Genzyme Reports Strong Fourth-Quarter Revenue Growth to Conclude Productive Year

January 10, 2007 - 8:22 AM

Company Expects 2007 Revenue of $3.6-$3.8 Billion Non-GAAP EPS of $3.10-$3.20

CAMBRIDGE, Mass., Jan. 9 /PRNewswire-FirstCall/ -- Genzyme Corp. (NASDAQ:GENZ) announced today that revenue increased 17 percent in the fourth quarter of 2006 to $852 million, up from $729 million in the fourth quarter a year earlier. For the year, revenue grew 16 percent to $3.2 billion from $2.7 billion in the previous year.

Genzyme reported these and other preliminary, unaudited revenue figures today in conjunction with a presentation by Chairman and Chief Executive Officer Henri A. Termeer at the JPMorgan 25th Annual Healthcare Conference in San Francisco. The company will report full financial results for 2006 on February 14.

"Record top-line results in the fourth quarter culminated a year that truly demonstrated the sustainability of our business," said Mr. Termeer. "It was also a year in which we set the stage for future growth by further building our commercial and manufacturing infrastructure and by advancing or completing many late-stage clinical trials. During the coming year, we expect to report results from approximately ten pivotal studies and to push forward with efforts to introduce new products that promise to change the clinical picture for a number of devastating diseases."

Genzyme also reported today that it expects 2007 revenue of $3.6-$3.8 billion and non-GAAP earnings of $3.10-$3.20 per share. This earnings estimate does not reflect the impact of the company's fourth-quarter acquisition of AnorMED Inc. because the accounting for that transaction has not been completed. Genzyme intends to provide earnings estimates that reflect the impact of the AnorMED acquisition on Feb. 14 when it provides more detailed financial guidance with its audited 2006 results. Non-GAAP estimates also exclude amortization and stock-compensation expenses, along with the dilutive impact of contingent convertible debt.

Genzyme's performance in 2006 caps a six-year period in which sales have increased at a compound annual rate of approximately 27 percent, driven by the company's strategy to diversify its product portfolio and further extend its global reach. During this period, Genzyme's reliance on its first product, Cerezyme(R), to sustain its growth has decreased markedly. Cerezyme sales in 2006 represented 32 percent of all revenue, down from 71 percent in 2000. Moreover, Genzyme's international sales from 2000-2005 increased at a compound annual rate of 31 percent, compared with a 28 percent rate for U.S. sales, underscoring the benefit of the company's investment in its global infrastructure.

Genzyme's diverse set of products and its commitment to operate in a broad range of global markets provide a platform for consistent and sustainable future growth. Based on the growth of its current marketed products alone, the company expects its annual revenue to approximately double over the next five years. Behind these products is a robust late-stage pipeline of potential new therapies. This year, Genzyme expects to initiate, conduct or complete 20 pivotal trials for new products or new indications to further expand and diversify its portfolio and contribute to its longer-term growth.

Genetic Diseases


Genzyme now markets treatments for four lysosomal storage disorders. Last year, the company obtained approval for Myozyme(R) (alglucosidase alfa), the first product ever developed for Pompe disease, a progressive, debilitating and often fatal neuromuscular disorder. Myozyme is off to a strong start. It was launched in Europe and the United States during the second quarter of 2006, and more than 550 patients in approximately 35 countries are currently on therapy. Sales grew significantly in the fourth quarter, increasing to $30 million. This year, Genzyme expects to launch Myozyme in Japan, Brazil and a number of additional markets. Myozyme recently received the prestigious Panorama del Medicamento award as the most innovative drug of 2006 in Spain, as deemed by the National Pharmaceutical Council, the highest professional body of Spanish pharmacists. In September, Myozyme earned the 2006 UK Prix Galien Gold Medal, presented bi-annually to new products judged to be the most innovative.

Results from the pivotal clinical trial of Myozyme were published last month in Neurology. Results from the ongoing study of Myozyme involving patients with late-onset Pompe disease are expected later this year and will be submitted to regulatory authorities in 2008. The 90-patient trial is intended to provide further support for Myozyme's use. Using an innovative adaptive design procedure, the duration of this trial has been extended for six months and will now end this fall when all patients will have completed 18 months of treatment.

Fourth-quarter sales of Fabrazyme(R) (agalsidase beta) for Fabry disease were $96 million, up 18 percent from $82 million in the same quarter a year ago. For the year, Fabrazyme sales grew 18 percent to $359 million, compared with $305 million in the previous year. More than 1,900 patients in approximately 45 countries are currently treated with Fabrazyme. Results from the Phase 4 clinical trial of Fabrazyme were published last month in Annals of Internal Medicine. The trial showed that Fabrazyme reduced the risk of major clinical events that cause death and disability in Fabry disease. It is the only major outcomes study to be conducted involving Fabry patients.

Fourth-quarter sales of Cerezyme(R) (imiglucerase for injection) enzyme replacement therapy for Type 1 Gaucher disease were $262 million, 13 percent greater than sales of $232 million in the fourth quarter a year ago. For the year, Cerezyme sales were $1.0 billion, up 8 percent from $932 million the year before. More than 4,800 patients in approximately 90 countries are currently receiving Cerezyme.

Sales of Aldurazyme(R) (laronidase) enzyme replacement therapy for MPS I were $27 million in the fourth quarter, compared with $21 million in the same quarter a year ago. For the year, Aldurazyme sales were $96 million, compared with sales of $76 million in the previous year. Aldurazyme is marketed through a joint venture with BioMarin Pharmaceutical Inc., and product sales are not included in Genzyme's revenue figures. More than 500 patients in approximately 40 countries are currently receiving Aldurazyme. The product was approved in Japan during the fourth quarter.

Sales of Thyrogen(R) (thryotropin alfa for injection) increased 18 percent in the fourth quarter to $25 million, compared with $21 million in the same period a year ago. For the year, Thyrogen sales rose 21 percent to $94 million from $78 million in the previous year.

Renal


Within the Renal business, Genzyme markets Renagel(R) (sevelamer hydrochloride), a phosphate binder for patients with end-stage renal disease on hemodialysis, and Hectorol(R) (doxercalciferol), a line of Vitamin D2 products for secondary hyperparathyroidism in dialysis patients and those with earlier stages of chronic kidney disease.

Fourth-quarter revenue for Renagel grew 22 percent to $135 million, compared with $110 million in the same quarter a year ago. For the year, revenue grew 23 percent to $515 million, compared with $417 million in the previous year. More than 350,000 patients in approximately 50 countries are currently treated with Renagel. The product's growth is being driven by a number of factors, including the communication of data highlighting the clinical and economic benefits of the product. Results from the RIND study published this month in Kidney International showed that patients using Renagel experienced a significantly lower rate of death compared with patients using calcium-based phosphate binders. At the American Society of Nephrology meeting in November, investigators presented three-year hospitalization and health economic data from the DCOR study showing that patients using Renagel experienced lower rates of hospitalization, fewer days in the hospital, and reduced overall health care expenditures compared to patients treated with calcium-based phosphate binders.

The development of sevelamer carbonate, a next-generation version of Renagel, took a major step forward in the fourth quarter when Genzyme submitted a New Drug Application to the FDA seeking approval of sevelamer carbonate for the control of serum phosphorus in patients with chronic kidney disease on dialysis. Genzyme expects to launch the product commercially in 2008 under the trade name Renvela(TM). Following the anticipated approval of Renvela, Genzyme plans to submit a supplemental NDA seeking marketing approval for the product's use in treating hyperphosphatemic patients with chronic kidney disease who are not on dialysis. The company also intends to seek approval for a powder form of Renvela taken once per day, which would provide patients with a more convenient formulation and dosing schedule that could help improve compliance.

Hectorol sales were $27 million in the fourth quarter, 30 percent greater than sales of $20 million in the same quarter a year ago. For the year, Hectorol sales were $93 million. Genzyme began selling Hectorol in mid-2005 following its acquisition of Bone Care International. More than 85,000 patients are currently being treated with Hectorol in the United States. Genzyme is working to register the product globally.

Biosurgery


Fourth-quarter sales of Synvisc(R) (hylan G-F 20) were $60 million, compared with sales of $58 million in the same quarter a year ago. For the year, Synvisc sales were $233 million, compared with $219 million in the previous year. Synvisc is a market-leading viscosupplement used to treat pain caused by osteoarthritis of the knee. Last month, the Centers for Medicare and Medicaid Services preserved a separate reimbursement code and rate for Synvisc for 2007, reversing an earlier decision that would have assigned a single reimbursement code to all viscosupplement products.

This action not only maintains the current reimbursement structure for Synvisc, but also continues to encourage innovation in the field. Genzyme has invested in developing potential next-generation approaches to viscosupplementation to reduce the burden of treatment and overall cost of therapy. In December, the company reported preliminary results from a study showing that patients who received Synvisc through a single-injection regimen achieved a statistically significant improvement in pain from osteoarthritis of the knee over 26 weeks compared with those using placebo. Currently Synvisc is delivered through three injections given at one-week intervals. Genzyme plans in the first half of this year to request an amendment to the Synvisc product label in the United States and Europe to include a single- injection regimen, which would significantly improve the product's ability to compete with products requiring a greater number of injections.

Sales of Sepra(TM) anti-adhesion products were $23 million in the fourth quarter, 31 percent greater than $17 million in the fourth quarter a year ago. For the year, sales of Sepra products were $85 million, an increase of 25 percent compared with $68 million a year earlier.

Transplant


Within the Transplant area, combined sales of Thymoglobulin(R) (anti- thymocyte globulin, rabbit) and Lymphoglobuline(R) (anti-thymocyte globulin, equine) increased 14 percent in the fourth quarter to $39 million, up from $35 million during the same period last year. For the year, sales were $149 million, 17 percent greater than $128 million in the previous year.

Diagnostics/Genetics


Total revenue for the Diagnostics/Genetics business increased to $93 million in the fourth quarter, up 8 percent compared with $86 million in the fourth quarter a year ago. For the year, revenue was $356 million, up 9 percent compared with $327 million a year ago. This year, Genzyme introduced six new personalized medicine tests, which are designed to provide physicians and patients with critical information to help determine how patients are likely to respond to targeted therapies.

Other revenue-including oncology revenue, sales of pharmaceutical intermediates, R&D revenue, and royalties from the sale of WelChol(R) (colesevelam hydrochloride)-was $44 million in the fourth quarter, 19 percent greater than $37 million in the same quarter last year. For the year, other revenue was $158 million, a 17 percent increase from $135 million in the previous year.

Oncology


Oncology revenue was $17 million in the fourth quarter, an increase of 44 percent compared to $12 million in the same period last year. For the year, oncology revenue was $59 million, 31 percent greater than $45 million for the previous year. Oncology revenue includes profits and royalties from Campath(R) (alemtuzumab for injection), which is marketed by Schering AG and its U.S. affiliate Berlex; sales of Clolar(R) (clofarabine for intravenous infusion); and R&D revenue.

Genzyme is working to broaden the indications for Campath and Clolar to benefit larger patient populations. Data from the CAM 307 trial presented at the annual American Society of Hematology meeting demonstrated that Campath significantly improved progression-free survival in comparison to chlorambucil in previously untreated patients with B-cell chronic lymphocytic leukemia, with Campath reducing the risk of disease progression or death by 42 percent. Campath received accelerated U.S. approval in 2001, and CAM307 was the primary post-approval commitment study designed to support full approval. Campath is currently indicated for the treatment of B-CLL in patients who have been treated with alkylating agents and who have failed fludarabine therapy. Genzyme and Schering AG expect to submit U.S. and European applications this year to expand the product's current label to include first-line treatment of B-CLL patients.

Genzyme is seeking to expand Clolar's indication to include adult patients with acute myelogenous leukemia (AML). The product is currently indicated for the treatment of pediatric patients with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. In November, Genzyme began a trial examining the safety and effectiveness of Clolar in previously untreated, older adult patients with AML who are unlikely to benefit from standard induction therapy. This was the second pivotal clinical study of clofarabine in adult patients with AML to begin last year, and it is expected to provide substantial support for expanding the current product label.

Additional Pipeline Highlights


* Results from the phase 3 trial of tolevamer are expected to be available during the second half of this year. Pending a positive outcome, the first commercial approval is anticipated in 2008. Tolevamer is a novel polymer therapy that could be the first non-antibiotic treatment for Clostridium difficile-associated diarrhea, a widespread and growing global problem primarily affecting patients in hospitals and nursing homes. The prevalence and impact of Clostridium difficile are becoming increasingly more visible as public health officials and others look for new ways to manage this disease.

* Following an encouraging meeting with the FDA in November, Genzyme expects to initiate during the first half of this year a phase 3 study of alemtuzumab (Campath) for the treatment of relapsing/remitting multiple sclerosis. The company is currently developing the study protocol to submit to the agency for review. Two-year results from a pre-planned interim analysis of the three-year phase 2 study were released in September and showed a robust, statistically significant treatment effect for alemtuzumab compared with Rebif(R) (interferon beta-1a). The IND for this trial remains on clinical hold in the United States, and Genzyme is working closely with clinical investigators and regulatory agencies to complete the study and ensure that the risk of immune thrombocytopenic purpura (ITP) is well understood and managed. Genzyme has implemented a comprehensive risk management plan to help physicians and patients participating in the trial detect ITP early and minimize the risk of complications.

* Through its November 2006 acquisition of AnorMED, Genzyme obtained a promising new product candidate, Mozobil(TM) (plerixafor) for use in stem cell transplantation procedures. Mozobil is an experimental product in late-stage clinical development that is designed to improve the outcome of stem cell transplantation in patients with blood cancers. Enrollment is complete in a pivotal Phase 3 trial for Mozobil in multiple myeloma and a second pivotal Phase 3 trial in non-Hodgkin's lymphoma. Results from both studies are expected in mid-2007.

* In the lysosomal storage disease area, enrollment is continuing in an international, multi-center phase 2 clinical trial evaluating the safety and efficacy of the small molecule GENZ-112638 for the treatment of Gaucher disease. The trial will help determine the potential of this compound as an alternative or adjunct to enzyme replacement therapy. GENZ-112638 also may be applicable to several other lysosomal storage disorders in addition to Gaucher disease. Initiation of the phase 2 program follows completion of an extensive pre-clinical research effort and a phase 1 program that involved more than 120 subjects in three separate studies.

* Genzyme and partner Dyax Corp. have completed the double-blind portion of the Phase 3 clinical trial known as EDEMA3 for DX-88 (ecallantide) for the treatment of hereditary angioedema (HAE). The second phase of the study, which continues to treat patients, allows for open-label DX-88 to be administered for acute attacks. Results from the study are expected to be available in the first half of this year.

About Genzyme


One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 9,000 employees in locations spanning the globe and preliminary, unaudited 2006 revenues of $3.2 billion. Genzyme has been selected by FORTUNE as one of the "100 Best Companies to Work for" in the United States.

With many established products and services helping patients in more than 80 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant and immune diseases, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as heart disease and other areas of unmet medical need.

This press release contains forward-looking statements, including statements regarding: 2006 unaudited revenues; 2007 revenue and earnings estimates; plans for the launch of Myozyme in Japan, Brazil and additional markets and the timing thereof; plans for Renvela, including anticipated approval, launch timing and label scope; plans to seek approval of a single- injection administration of Synvisc and the timing thereof; plans for tolevamer, including timing of commercial launch; the initiation of a phase 3 trial of alemtuzumab for MS and the timing thereof; plans to expand the use of Campath and Clolar into earlier-line and additional indications; 2011 revenue estimates; the timing of the receipt of clinical trial data for Myozyme, tolevamer, Mozobil and DX-88; expectations regarding the number of pivotal trials initiated, conducted or completed in 2007; as well as other statements regarding Genzyme's future performance and strategy. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those forecast in these forward-looking statements. These risks and uncertainties include, among others, Genzyme's ability to successfully complete preclinical and clinical development and post-marketing commitments for its products and services; Genzyme's ability to expand the use of current products in existing and new indications and geographic areas; the content and timing of actual submissions to and decisions made by the FDA, EMEA and other regulatory agencies; Genzyme's ability to successfully identify and market to new patients; the availability of reimbursement for Genzyme's products and services, including Synvisc, the extent of that coverage and the accuracy of Genzyme's estimates of the payor mix; and the risks and uncertainties described in Genzyme's SEC reports filed under the Securities Exchange Act of 1934, including the factors discussed under the caption "Factors Affecting Future Operating Results" in Genzyme's Quarterly Report on Form 10-Q for the period ended September 30, 2006. Genzyme cautions investors not to place substantial reliance on the forward-looking statements contained in this press release. These statements speak only as of January 9, 2007, and Genzyme undertakes no obligation to update or revise the statements.

Genzyme(R), Cerezyme(R), Myozyme(R), Fabrazyme(R), Aldurazyme(R), Thyrogen(R), Renagel(R), Hectorol(R), Synvisc(R), Campath(R), Clolar(R), Thymoglobulin(R) and Lymphoglobuline(R) are registered trademarks, and Renvela(TM), Mozobil(TM), and Sepra(TM) are trademarks of Genzyme Corporation or its subsidiaries. WelChol(R) is a registered trademark of Sankyo Pharma Inc. All rights reserved.

This press release includes certain non-GAAP financial measures that involve adjustments to GAAP figures. Genzyme believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of Genzyme's past financial performance and its prospects for the future. The non-GAAP financial measures are included with the intent of providing both management and investors with a more complete understanding of underlying operational results and trends. In addition, these non-GAAP financial measures are among the primary indicators Genzyme management uses for planning and forecasting purposes. These non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP figures.

Webcast Information


Mr. Termeer's presentation will be Webcast live at 12:00 p.m. Eastern Time on the investor events section of www.genzyme.com. A replay of the presentation will be available immediately and will be accessible until January 16, 2007.


Upcoming Events


On February 14, 2007, Genzyme will announce its financial results for the fourth quarter of 2006 and financial guidance for 2007. There will be a conference call at 11:00 a.m. Eastern. If you would like to participate in the call, please dial (706) 679-8722. This call will also be Webcast on the investor events section of www.genzyme.com. A replay of the Webcast and call will be available from 2:15 p.m. Eastern through midnight on February 21, 2007. For the replay, please dial (706) 645-9291 and refer to reservation number 4245727.

Genzyme's press releases and other company information are available at www.genzyme.com and by calling Genzyme's investor information line at 1-800-905-4369 within the United States or 1-703-797-1866 outside the United States.


Media Contact: Investor Contact:
Bo Piela Sally Curley
(617) 768-6579 (617) 768-6140

Source: Genzyme Corp.

CONTACT: Media, Bo Piela, +1-617-768-6579, or Investors, Sally Curley,
+1-617-768-6140, both of Genzyme Corp.


Web site: http://www.genzyme.com/

Biogen Idec Begins Phase III Clinical Program of Medicine for Multiple Sclerosis

Biogen Idec (NASDAQ: BIIB) announced today that it has initiated the Phase III clinical program of BG-12, an oral fumarate in development for relapsing-remitting multiple sclerosis (MS).

The DEFINE (determination of the efficacy and safety of oral fumarate in relapsing-remitting MS) and CONFIRM (comparator and an oral fumarate in relapsing-remitting MS) studies will include more than 2,000 total patients in North America, Europe and rest of world.

These studies have been initiated internationally, and Biogen Idec plans to initiate these studies in the U.S. later this year. DEFINE and CONFIRM are two-year, randomized, multi-center, double-blind, placebo-controlled, dose-comparison studies to determine the safety and efficacy of BG-12 in subjects with relapsing-remitting MS. CONFIRM will also include a glatiramer acetate (Copaxone(R)) reference comparator arm.

Endpoints of both studies include evaluating the effect of BG-12 on measurements of clinical relapse, the progression of disability, and various MRI measures.

"Earlier studies of BG-12 support its potential as an oral therapy for multiple sclerosis. The extensive Phase III clinical program of

BG-12 will provide greater understanding of its promise in MS," said DEFINE lead investigator Ralf Gold, MD, Professor and Chair of the Department of Neurology, St. Josef-Hospital/Ruhr-University Bochum.

"MS is a disease that continues to have an unmet need for safe and effective oral therapeutic options."

"The development of BG-12 furthers Biogen Idec's commitment to advancing the treatment of MS. We have a diverse portfolio of therapeutic candidates and are dedicated to the pursuit of innovative research that will yield multiple options for people living with this devastating disease,"said Alfred Sandrock, MD, PhD, Senior Vice President, Neurology Research and Development, Biogen Idec.

BG-12 Phase II Study Results

Data from a Phase II study designed to evaluate the efficacy and safety of BG-12 were presented at two European neurological medical meetings in 2006. The Phase II multi-center, double-blind, placebo-controlled, dose-ranging study enrolled 257 patients at sites in 10 countries in Europe. Patients were randomized to receive placebo or BG-12 at 120 mg, 360 mg, or 720 mg per day orally for six months.

The patient group treated with 720 mg of BG-12 per day had a 69% reduction (p<0.001) in the mean number of new gadolinium-enhancing lesions versus placebo as measured monthly from weeks 12 to 24 of the study. The 720 mg dose group also had a 48% reduction (p<0.001) in new or newly enlarging T2-hyperintense lesions at six months compared to baseline. Although the study was not powered to achieve statistical significance for this endpoint, there was a 32% reduction (p=0.272) in relapse rate compared to placebo at the 720 mg dose. The results of the 120 mg and 360 mg BG-12-treated groups were not statistically significant versus placebo on any endpoints.

The most common adverse events were flushing, gastrointestinal disorders, headache, and nasopharyngitis. The incidence of liver enzyme elevation greater than or equal to three times the upper limit of normal at any time during the placebo controlled phase of the study was between 2% and 8% in the three active treatment groups, compared with 5% in the placebo group. Improvement in liver enzyme levels was seen after discontinuation of BG-12. The overall rate of infection was the same in the total BG-12-and placebo-treated groups, and no opportunistic infections occurred.

About BG-12

Data suggest that BG-12, an oral fumarate derivative, is an immunomodulator with a novel mechanism of action with a combination of cytoprotective and anti-inflammatory properties. Based on available clinical and scientific information with BG-12 and fumarates, there is strong technical rationale for development of BG-12 in a number of T-cell mediated autoimmune and/or inflammatory diseases.

About Biogen Idec

Biogen Idec creates new standards of care in oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. © 2007 NoticiasFinancieras - Business Wire Latin America - All rights reserved

Letter: MS measure will help cover therapy

By LYNDA CHOTT, Chapter President and MAUREEN HOWARD, Board Member/AGRC chair
National Multiple Sclerosis Society Greater Illinois

At this very moment, someone with multiple sclerosis (MS) is battling the bureaucracy of her insurance company so that she can continue getting coverage for the physical therapy services that have kept her out of a wheelchair, stopped atrophy in her muscles and kept her active in her community. It’s a battle that’s fought across the country, but here in Illinois, we are close to passing a law that will ensure that it will never happen to another person living with MS again.

The National Multiple Sclerosis Society -- Greater Illinois Chapter is urging Governor Blagojevich to sign into lAt this very moment, someone with multiple sclerosis (MS) is battling the bureaucracy of her insurance company so that she can continue getting coverage for the physical therapy services that have kept her out of a wheelchair, stopped atrophy in her muscles and kept her active in her community. It’s a battle that’s fought across the country, but here in Illinois, we are close to passing a law that will ensure that it will never happen to another person living with MS again.

The National Multiple Sclerosis Society -- Greater Illinois Chapter is urging Governor Blagojevich to sign into law SB 2917, which would secure insurance coverage of preventative physical therapy for people living with MS in Illinois. SB 2917 passed unanimously in both the Illinois House and Senate. The bill, drafted in cooperation with Blue Cross Blue Shield, will help thousands of people with MS maintain their mobility, enhance the quality of their lives, and remain vital members of the community.

The MS community extends its deepest appreciation to Speaker Michael Madigan for his leadership and support for this legislation. We sincerely thank our sponsors, Sen. Maggie Crotty, Sen. William Haine, and Rep. Robert Rita for their commitment to this legislation, as well as our many co-sponsors.

Physical therapy has been cliniclly proven to help thousands of MS patients maintain their mobility and strength. But currently, once a patient stops getting “better,” insurers decline coverage for continued physical therapy. The goal of physical therapy for MS patients is to maintain current mobility -- not to improve it so coverage is typically denied -- SB 2917 will right that wrong. By signing the bill, Gov. Blagojevich will help improve the access to care that people living with MS need.

Stem cell centre plan confirmed

Stem cells could be used to treat a number of human diseases

A world-leading centre in stem cell science and regenerative medicine is to be built in Edinburgh, ministers have confirmed.
Additional Scottish Executive funding of £24m will allow Edinburgh University to develop the £59m centre in collaboration with Scottish Enterprise.

The Scottish Centre for Regenerative Medicine (SCRM) is thought to be equalled only one in Kobe, Japan.

Prof Ian Wilmut, formerly of the Roslin Institute, will be the director.

The state-of -the-art facilities are expected to house 220 academic researchers and will include a centre for "scale-up" development and manufacture of cells. Space will also be made available for commercial regenerative medicine.

It is hoped that the SCRM, which will be part of the new Centre for Biomedical Research at Edinburgh's Little France, will create about 560 jobs and generate £18.2m per year for the Scottish economy.


The technologies and potential health treatments based on stem cell research have tremendous potential for both health and economic development
Jack McConnell
First Minister

"This will be a fantastic development for Edinburgh, a significant boost to the Scottish economy and will be at the forefront of improving the lives of people right around the world for decades to come," said First Minister Jack McConnell during a visit to the site.

The project will draw on the country's well-established strengths in regenerative medicine using stem cell technologies and allow Scotland to become a European leader in medical research, according to Mr McConnell.

"The technologies and potential health treatments based on stem cell research have tremendous potential for both health and economic development, with the prospect of delivering significant breakthroughs in the clinical treatment of some of the most degenerative diseases," he added.

The announcement comes as the Human Fertilisation and Embryology Authority is expected to make an announcement about research into hybrid embryos.

The research, which involves the creation of part-animal, part-human embryos, has attracted controversy but leading scientists believe its use could help patients with serious diseases such as Alzheimer's and motor-neurone disease.


Mr McConnell hopes Scotland will be leading centre for research

Prof Wilmut, who joined other experts earlier this week in urging the fertility watchdog not to bar research into hybrid embryos, stressed his belief that it was necessary and claimed the procedure would be carried out using transplanting cells at the new centre, if allowed.

Prof Timothy O'Shea, University of Edinburgh principal, said the centre would make a significant contribution to the health of many people across the world.

"Scotland has a world lead in fundamental stem cell sciences," he added. "The most important area of application is regenerative medicine, particularly in relation to degenerative diseases such as multiple sclerosis and Parkinson's disease."

As well as the £24m package announced by the executive, the University will put in £19m and a further £16m will be provided by the Scottish Enterprise, subject to its board's approval later this month.

"My colleagues within the Scottish Enterprise Network have been working extremely closely with our partners to bring this project to fruition and position Scotland as a global leader in stem cell research and development," said Jack Perry, chief executive of Scottish Enterprise.

Anne Glover, chief scientific adviser for Scotland, added: "Scotland is internationally renowned for the breadth and depth of its stem cell expertise.

"This initiative has the potential to significantly expand areas for research and development and further strengthens Scotland's international profile in this area."

It is anticipated that the centre will be completed by 2010.

Stem cell treatment did not work for Mt’mellick patient

By: Chris Fingleton

A MOUTMELLICK resident, who last year under-went radical stem cell treatment in his battle against multiple sclerosis, has admitted that, “the treatment did not work” and has branded the doctor who carried it out as “a cheat and a fake”.
Vernon Mulqueeney, who is originally from Newbridge, was struck down with multiple sclerosis in 2002. Last year, Vernon turned himself into a human guinea pig in his battle against the dis-ease and after a major fund-raising effort under-taken by his family and friends, was able to fork out •20,000 to have the revolutionary treatment at an Irish hospital. He still refuses to name the exact location, other than say it was in the south of the country.

Now, all most a year later and confined to a wheelchair, Vernon has admitted that the treat-ment did not work, even though he initially thought it had been successful.

We knew from the word go it wasn’t what it was meant to be, but you’re always hoping for the best. I should feel a lot worse than I do,” said Vernon.

“I’m in a wheelchair now and my eyesight is a little worse and this all happened just a few months after the treat-ment,” he added.

Describing his current condition Vernon told the Laois Nationalist: “I now have very little mobility in my limbs and I still can’t read a newspaper or a book. Maybe that is why I feel it safer to be in a wheelchair.”

Although disappointed the stem cell treatment did not work, Vernon admitted that if someone came knocking on his door, he would still “take hand and all” if they offered him a cure.

“I still have a positive outlook. I have to because I’ve a wife and three children. You have to remain positive.

Asked if he felt cheated by the doctor who carried out the treatment Vernon said: “Of course I do - if I was to dwell on it and yes of course I feel cheated but I wanted a miracle and I put myself in that situation. I trying to be polite but I don’t know what they were. When I look back I often ask myself was that a bloody doctor at all? I now realise he was a fake.”

“I’ve moved on, there is no point dwelling on it. I’m still gob-smacked at the generosity of the people. . I would have loved to move on in a different direction but it wasn’t meant to be,” he said.

Air base project gets conditional OK

State wants details on cleanup, impact
By Emily Sweeney, Globe Staff | January 11, 2007

Developers of the former South Weymouth Naval Air Station have won initial state environmental approval -- it came on Dec. 15 -- but several hurdles remain before the suburban commuter village named SouthField becomes a reality.

State Environmental Secretary Robert W. Golledge Jr. , in his 24-page approval of the development's draft enviro n mental impact report, wrote that SouthField is "a project that has the potential to establish a new standard for environmentally responsible development," but that the developers need to provide more detailed information in their final report.

Specifically, he asked for updates on the hazardous waste sites, more details about the proposed roadway that will be built, and additional analysis of the project's impact on wetlands.

The final environmental impact report "should briefly summarize measures that will be implemented to recognize and respond to unknown hazardous waste sites and cite plans . . . that identify specific measures to be implemented," Golledge wrote.

Golledge also requested that the developers work closely with town officials in Weymouth, Abington, and Rockland to address concerns about traffic as the former World War II blimp base is transformed into what is believed to be the largest planned community in New England.

"We're going to work hard to meet those conditions," said Bill Ryan, the former Weymouth selectman who works as a consultant for the developer, LNR Property Corp. "We're optimistic that there's not any showstoppers in there."

LNR is still negotiating with the Navy on getting rights to the rest of the property.

There are 10 Superfund sites on the base, and the Environmental Protection Agency and state Department of Environmental Protection are overseeing the Navy's environmental cleanup. Plans to clean up five of those contaminated sites are still being finalized.

The Massachusetts Department of Public Health has been evaluating cases of multiple sclerosis near the former air station, and a report is scheduled to released in the next few months.

Tonight, the South Weymouth Naval Air Station Restoration Advisory Board will hold its regular monthly meeting to discuss the environmental issues and clean up activities at the former military base, the largest underdeveloped parcel on the South Shore.

The property is approximately 1.5 square miles, about the size of Boston's financial district and Back Bay combined. In phases over the next 10 years, LNR Property Corp. aims to build 2,855 houses and condos, 2 million square feet of commercial space, a sports center, a golf course, and recreation fields . The sweeping redevelopment plan has earned praise from the Massachusetts Office for Commonwealth Development, which gave it a 2006 Smart Growth Award in December.
LNR has permission to start a portion of the project -- construction of 500 housing units -- and a 150,000-square-foot office complex is expected to begin in the fall, according to Ryan.

Already the entrance to the old base is getting a makeover. The guard shack that faced Route 18 has been demolished, gray stone walls are being installed, and a landscaped entry way will soon display the site's new name: SouthField.
LNR Property Corp. has tapped the marketing power of Cushman & Wakefield to lure potential tenants to the new development.

SouthField now has its own website, southfield.com, featuring interactive maps, illustrations of people pedaling bicycles through the "SouthField Highlands" neighborhood, and detailed information on development opportunities ranging from residential townhouses to biopharmaceutical manufacturing facilities.

The South Weymouth Naval Air Station Restoration Advisory Board will hold its monthly meeting tonight at 7 in the conference center on Shea Memorial Drive. To view the project's draft environmental impact report, go to ssttdc.com.

Emily Sweeney can be reached at esweeney@globe.com.
© Copyright 2007 Globe Newspaper Company.

Biogen Idec Initiates Phase III Clinical Program of Oral Compound BG-12 for Multiple Sclerosis

Canada Newswire English - Jan. 09, 2007

Attention Business Editors, Health Writers

CAMBRIDGE, MASS., January 9 /CNW/ - Biogen Idec (NASDAQ: BIIB) announced today that it has initiated the Phase III clinical program of BG-12, an oral fumarate in development for relapsing-remitting multiple sclerosis (MS).

The DEFINE (determination of the efficacy and safety of oral fumarate in relapsing-remitting MS) and CONFIRM (comparator and an oral fumarate in relapsing-remitting MS) studies will include more than 2,000 total patients in North America, Europe and rest of world. These studies have been initiated internationally, and Biogen Idec plans to initiate these studies in the U.S. later this year. DEFINE and CONFIRM are two-year, randomized, multi-center, double-blind, placebo-controlled, dose-comparison studies to determine the safety and efficacy of BG-12 in subjects with relapsing-remitting MS. CONFIRM will also include a glatiramer acetate (Copaxone(R)) reference comparator arm.

Endpoints of both studies include evaluating the effect of BG-12 on measurements of clinical relapse, the progression of disability, and various MRI measures.

"Earlier studies of BG-12 support its potential as an oral therapy for multiple sclerosis. The extensive Phase III clinical program of BG-12 will provide greater understanding of its promise in MS," said DEFINE lead investigator Ralf Gold, MD, Professor and Chair of the Department of Neurology, St. Josef-Hospital/Ruhr-University Bochum. "MS is a disease that continues to have an unmet need for safe and effective oral therapeutic options."

"The development of BG-12 furthers Biogen Idec's commitment to advancing the treatment of MS. We have a diverse portfolio of therapeutic candidates and are dedicated to the pursuit of innovative research that will yield multiple options for people living with this devastating disease,"said Alfred Sandrock, MD, PhD, Senior Vice President, Neurology Research and Development, Biogen Idec.

BG-12 Phase II Study Results

Data from a Phase II study designed to evaluate the efficacy and safety of BG-12 were presented at two European neurological medical meetings in 2006. The Phase II multi-center, double-blind, placebo-controlled, dose-ranging study enrolled 257 patients at sites in 10 countries in Europe. Patients were randomized to receive placebo or BG-12 at 120 mg, 360 mg, or 720 mg per day orally for six months. The patient group treated with 720 mg of BG-12 per day had a 69% reduction (p(less than)0.001) in the mean number of new gadolinium-enhancing lesions versus placebo as measured monthly from weeks 12 to 24 of the study. The 720 mg dose group also had a 48% reduction (p(less than)0.001) in new or newly enlarging T2-hyperintense lesions at six months compared to baseline. Although the study was not powered to achieve statistical significance for this endpoint, there was a 32% reduction (p=0.272) in relapse rate compared to placebo at the 720 mg dose. The results of the 120 mg and 360 mg BG-12-treated groups were not statistically significant versus placebo on any endpoints.

The most common adverse events were flushing, gastrointestinal disorders, headache, and nasopharyngitis. The incidence of liver enzyme elevation greater than or equal to three times the upper limit of normal at any time during the placebo controlled phase of the study was between 2% and 8% in the three active treatment groups, compared with 5% in the placebo group. Improvement in liver enzyme levels was seen after discontinuation of BG-12. The overall rate of infection was the same in the total BG-12-and placebo-treated groups, and no opportunistic infections occurred.

About BG-12

Data suggest that BG-12, an oral fumarate derivative, is an immunomodulator with a novel mechanism of action with a combination of cytoprotective and anti-inflammatory properties. Based on available clinical and scientific information with BG-12 and fumarates, there is strong technical rationale for development of BG-12 in a number of T-cell mediated autoimmune and/or inflammatory diseases.

About Biogen Idec

Biogen Idec creates new standards of care in oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. For product labeling, press releases and additional information about the company, please visit http://www.biogenidec.com.

Safe Harbor/Forward-Looking Statements

This press release contains forward-looking statements regarding the development of BG-12 for multiple sclerosis. These statements are based on our current beliefs and expectations. They are subject to the risks inherent in drug development, including the risks that the effects of the product in larger clinical trials may not be as expected or that there may be safety issues or other problems or delays that arise during clinical trials, unexpected technical or manufacturing hurdles, or intellectual property disputes. There is no certainty that the risk/benefit profile of the product will be acceptable to the Company or to regulatory authorities for a particular indication. Drug development involves a high degree of risk. Only a small number of research and development programs result in the commercialization of a product. Success in early stage clinical trials does not ensure that later stage or larger scale clinical trials will be successful. For more detailed information on the risks and uncertainties associated with these forward looking statements and Biogen Idec's other activities, see the periodic and other reports that Biogen Idec has filed with the SEC. Biogen Idec does not undertake any obligation to publicly update any forward-looking statements.

Biogen Idec MEDIA CONTACTS: Amy Brockelman, 617-914-6524 or INVESTOR CONTACTS: Eric Hoffman, 617-679-2812

Incyte to Report Positive Preliminary Clinical Results from HIV and Diabetes Programs and Highlight Progress in Several Drug Development Programs at t

WILMINGTON, Del.--(BUSINESS WIRE)--Jan 8, 2007 - Incyte Corporation (Nasdaq: INCY) will announce today at the 25th Annual JPMorgan Healthcare Conference positive preliminary results from a Phase IIa placebo-controlled trial designed to evaluate the anti-viral effects and safety of INCB9471, Incyte's lead CCR5 antagonist that is being developed as a once-a-day oral treatment for patients with human immunodeficiency virus (HIV) infections. In the first seven treated patients the compound was well tolerated over the 14-day trial period with a 1.7 log10 viral load drop at day 14. Consistent with the compound's long half-life of 60 hours, viral replication continued to be suppressed after the last dose with a nadir in viral load reduction of 2.1 log10 seen at day 20.

Incyte will also announce today preliminary proof-of-principle results from a Phase IIa trial for INCB13739, its oral inhibitor of 11-beta hydroxysteroid dehydrogenase type 1 (11beta-HSD1) that is being developed as a treatment for type 2 diabetes. While this trial is still ongoing, in the six treated obese insulin resistant individuals who have completed the trial, a single dose of INCB13739 completely inhibited 11beta-HSD1 activity in both adipose tissue and liver - Incyte believes this is the first time such results have been reported for any 11beta-HSD1 inhibitor in man.


The ability to fully inhibit 11beta-HSD1 in these tissues, which are major contributors to the body's control of glucose metabolism, shows that INCB13739 has the necessary properties to demonstrate the potential therapeutic effect of 11beta-HSD1 inhibition in type 2 diabetes and related cardiovascular risk factors.

Incyte intends to submit for presentation, at appropriate scientific meetings, the full results from these two studies.

In his presentation at the JPMorgan Conference, Dr. Friedman will also describe progress in several of the company's drug development programs, including:

-- The initiation of a Phase I trial for a follow-on CCR5 antagonist, INCB15050, a potential once-a-day therapy for use in HIV-infected patients. This study is expected to complete in the first quarter of this year.

-- The filing of an Investigational New Drug Application (IND) for its lead CCR2 antagonist, INCB8696, which Incyte intends to develop first as an oral treatment for multiple sclerosis. Incyte may also pursue a second indication, lupus nephritis, and potentially other autoimmune nephritides. The Phase I trial is expected to initiate in the first quarter of this year.

-- The announcement of several new programs in inflammation and oncology involving oral inhibitors of the janus-associated kinases (JAKs). There are four JAK enzymes, JAK1, JAK2, JAK3 and TKY2, which are an essential part of the intracellular signaling mechanisms used by a number of cytokines and growth factors. Incyte has identified a range of potent, moderately selective, oral JAK2 inhibitors from multiple chemical scaffolds. A number of these compounds are expected to enter clinical trials beginning in the first quarter of this year.

"The JAK2 program has the potential to significantly expand our pipeline in areas that we can pursue on our own. We expect to file INDs for several indications beginning this quarter and to have proof-of-concept data for at least one of these before year-end," stated Dr. Friedman.

New JAK2 Program Has Therapeutic Potential in Multiple Disease Areas

Incyte's focus on developing oral JAK2 inhibitors is based on a growing body of clinical data suggesting that blocking signaling through the JAK2 pathway has therapeutic potential in a number of inflammatory and myeloproliferative diseases, and potentially other cancers. Clinical studies of monoclonal antibodies that inhibit cytokines which signal through JAK2, as well as with a moderately selective oral JAK3 inhibitor that also inhibits JAK2, have shown impressive clinical efficacy in rheumatoid arthritis and psoriasis, suggesting that the JAK2 pathway plays a pivotal role in inflammation. Given the dramatic efficacy of biological agents that act upon JAK2-driven signaling pathways, and given that inhibition of the JAK3 pathway is known to be immunosuppressive, Incyte has focused on the identification of inhibitors with greater selectivity for JAK2.

Additionally, Incyte believes there is strong genetic and early clinical evidence suggesting that blocking signaling through the JAK2 pathway may provide therapeutic benefits in a number of myeloproliferative diseases (MPDs), such as polycythemia vera, essential thrombocythemia and myeloid metaplasia.

Program Objectives for 2007

In today's presentation, Dr. Friedman will also review a number of 2007 objectives for the company's drug discovery and development programs including: -0-
1. In our HIV program, for our lead CCR5 antagonist, INCB9471,
present the final viral load reduction and safety data from the
Phase IIa trial, complete the required drug interaction studies,
and initiate a Phase IIb clinical study. For our follow-on CCR5
antagonist, INCB15050, complete Phase I and then determine
whether to further progress its development.

2. Present the final proof-of-principle data from the adipose fat
biopsy study and initiate and complete a one-month Phase IIa
clamp study in type 2 diabetics for INCB13739, our most advanced
11beta-HSD1 compound.

3. For our oral sheddase inhibitor INCB7839, complete the Phase
Ib/IIa dose-escalation trial in refractory cancer patients,
establish the maximum tolerated dose (MTD) and select a dose to
take forward in Phase II breast cancer trials and possibly one
other solid tumor type. In parallel, enroll additional cancer
patients into the Phase Ib/IIa trial, at the MTD, to assess
safety and potentially relevant biomarkers of sheddase inhibition
including HER2 extracellular domain levels, ECD.

4. For our lead CCR2 antagonist, INCB8696, initiate development as a
treatment for MS, beginning with a Phase I trial in healthy
volunteers.

5. For our JAK2 program, initiate several clinical trials, with the
potential to provide proof-of-concept results for at least one
indication before year-end.

6. Continue to advance additional follow-on compounds in our lead
programs as well as identify and progress new molecular entities,
targeted to clinically relevant targets, into IND-enabling
studies.

The Incyte presentation at the JPMorgan Healthcare Conference will be webcast live today at 11:30 am Eastern Time / 8:30 am Pacific Time and can be accessed at www.incyte.com under Investor Relations, Events and Webcasts. A replay of the presentation will be available for 30 days. Investors interested in listening to the live webcast should log on before the start time in order to download any required software.

Incyte is a Wilmington, Delaware-based drug discovery and development company with a growing pipeline of oral compounds to treat HIV, inflammation, cancer and diabetes. For additional information on Incyte visit the company's web site at www.incyte.com.

Forward-Looking Statements

Except for the historical information contained herein, the matters set forth in this press release, including statements with respect to expectations of advancing Incyte's preclinical and clinical compounds, completing and presenting data from several clinical 'proof-of-concept' Phase IIa and Phase I clinical trials for its compounds including Incyte's CCR5 antagonist compound INCB9471, its 11betaHSD-1 inhibitor compound INCB13739 and compounds from its new JAK2 program and expectations regarding the potential utility of Incyte's CCR5 antagonists, INCB13739 and its JAK compounds, expectations regarding the initiation of a Phase IIb study of INCB 9471 and a three month study for INCB 13739, expectations regarding the initiation and completion of Phase I clinical trials for Incyte's follow-on CCR5 antagonist compound INCB15050, expectations regarding the timing of initiation of Phase I for the CCR2 antagonist for the treatment of multiple sclerosis and plans for pursuing a second indication, expectations regarding the timing of IND filings and the initiation of several Phase I clinical trials for the new JAK2 inhibitor compounds currently in preclinical development, completion of the Phase Ib/IIa clinical trial and initiation of several Phase II trials for Incyte's sheddase inhibitor, INCB7839, and expectations regarding the advancement of new follow-on compounds and new molecular entities into IND-enabling studies, are all forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the high degree of risk associated with drug development and clinical trials, results of further research and development, the impact of competition and of technological advances and the ability of Incyte to compete against parties with greater financial or other resources, unanticipated delays, unanticipated cash requirements and the ability to raise additional capital, the ability to implement technological improvements, Incyte's ability to enroll a sufficient number of patients for its clinical trials, and other risks detailed from time to time in Incyte's filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2006. Incyte disclaims any intent or obligation to update these forward-looking statements.

Contact

Incyte Corporation
Pamela M. Murphy, 302-498-6944
Vice President, Investor Relations/Corporate
Communications

Doctors ‘kept policeman’s illness secret for 12 years’

A policeman from East Sussex has accused the medical profession of "playing God" for not telling him he had multiple sclerosis for more than ten years.

PC Gary Dimmock, 42, from Westham, has received more than £10,000 compensation in an out-of-court settlement from the East Sussex Hospitals NHS Trust.

His GP suspected multiple sclerosis in 1992 but he was not diagnosed until 2003.

His lawyers successfully argued that he should have begun treatment at least 12 years ago. They said he developed far worse symptoms as a result of not being treated.

The officer said doctors hid the news from him by exercising their right to "therapeutic privilege".

He feared he had MS after researching the condition on the internet but said he was dismissed as a "cyberchondriac" by his GP when he raised his suspicions.

Multiple sclerosis is a disabling neurological condition whereby the body's immune system attacks itself, causing fatigue and limb weakness. There is no cure for the condition and some sufferers experience difficulty in swallowing and muscle spasms or tremors.

PC Dimmock said he was "ping-ponged" back and forth for years between his GP, his consultant neurologist at Eastbourne District General Hospital, and an ophthalmologist. All their notes made reference to him having MS but no one told him the truth.

He said: "When I saw the medical notes for the first time I cried. They were littered with references to MS."

Stem cell breakthrough that could end the storm

A major breakthrough in stem cell science could quell the controversy surrounding the cutting-edge medical research, it was revealed.

Scientists have shown for the first time that amniotic fluid is a rich source of stem cells, suggesting the powerful cells can be ethically harvested. Stem cells are hugely important in the hunt for new treatments for conditions such as Parkinson's disease, Alzheimer's, multiple sclerosis, heart disease and strokes. Blank cells, capable of turning into different types of tissue, they are seen as a repair kit, with the potential to regenerate damaged parts of the body.

Embryonic stem cells - plucked from an embryo in the first days of life - are more versatile than those gleaned from adults as they are capable of turning into virtually any form of cell. However, research on embryonic stem cells is mired in controversy, as extraction of the cells lead to the death of the embryo - and protests that human life, even in its earliest stages, is being sacrificed in the interests of medical research.

Now, US researchers have shown that amniotic fluid could provide an alternative - and more ethically acceptable - source of stem cells. They found that human stem cells, shed by the unborn baby into the surrounding amniotic fluid, can be coaxed into turning into muscle, bone, fat, blood vessel, nerve and liver cells in the lab. When the nerve cells were transplanted into mice with a degenerative brain disease, they grew and repopulated the diseased areas. Bone and liver cells also functioned well, the journal Nature Biotechnology reports. In addition to being easily obtainable, the cells can be grown quickly in large quantities.

Although stem cells have been extracted from amniotic fluid before, this is the first time they have been shown to have such broad potential. Researcher Professor Anthony Atala, of Wake Forest University in North Carolina, said: 'These cells are capable of extensive self-renewal, a defining property of stem cells.

'They can also be used to produce a broad range of cells that may be valuable for therapy.

'Our hope is that these cells will provide a valuable resource for tissue repair and for engineered organs as well.'

The scientists also showed that the same cells are found in the placenta. However, stem cells taken from the umbilical cord are much harder to grow and so not so useful. The amniotic fluid - which would otherwise have been discarded - was taken from pregnant women for amniocentesis, a test commonly used to detect Down's Syndrome and other genetic conditions in the unborn baby. In the future, the cells could be collected after amniocentesis tests or from the placenta when it is expelled after the birth of the baby. They could then be banked until needed later in life either by the individual or by others.

Prof Atala said: 'In the future, banking of these stem cells may provide a convenient source for both therapy in later life and for matching of donor cells with recipients.'

Professor Malcolm Alison, a stem cell expert from the University of London, said the researchers had found a new, ethically-acceptable source of stem cells that are at least as versatile as the much-feted embryonic stem cells.

'It is a readily available source and an attractive source that would otherwise be thrown away,' said Prof Alison. 'They appear to be at least as malleable as embryonic stem cells but without all the ethical baggage.'

Reproductive ethics campaigner Josephine Quintavalle said:'The extras of childbirth have wonderful life-giving potential,' she said. 'We need to outline to the public that these cells can be obtained ethically, without any sacrifice of embryos.'

Paul Tully, of the Society for the Protection of Unborn Children, said it was wrong to invest so much time and hope in embryonic stem cell research,' he said. 'It is entirely unreasonable to suggest that the only possible treatment offers hope to someone with Parkinson's disease, motor neurone disease or other conditions,' he said.
'There are many avenues of stem cell research apart from embryonic stem cells which are proving very exciting and have great possibilities.'

Jim Dobbin, chairman of the All-Party Party Pro-Life Group, said he would welcome the use of stem cells from the amniotic fluid, provided they could be extracted without harming the unborn baby. However, other scientists cautioned that more work has to be done to establish the true potential of these stem cells. Professor Stephen Minger, a stem cell expert from King's College London, said that while it would be useful to have other sources of stem cells, there would always be a place for embryonic stem cells in research. 'This isn't a way of saying we don't need embryonic stem cells,' he said. 'This is interesting work but it needs to be reproduced on a large scale.' He added that it is unclear whether the cells would still be of use after being stored for a long period.

Stem cell research offers hope for treating and curing a host of conditions. Powerful opponents of embryonic stem cell research include the Vatican and George Bush. President Bush, who has banned government funding of stem cell research in the US, is said to view the use of embryonic stem cells as 'murder'.

Vetoing funding, he said: 'It crosses a moral boundary that our decent society needs to respect.'

However, the work has also attracted much praise with actor Michael J Fox, who suffers from Parkinson's disease campaigning for politicians who support research on human embryos. And, in the last few days of his life, Superman actor Christopher Reeve recorded an advert which stated stem cells were 'the future of medicine'.

Last month, it emerged that London doctors are about to start injecting heart attack patients with stem cells in bid to repair damaged muscle damaged during the attack. Also in recent weeks, British scientists have revealed they have grown a mini-liver - a tiny bundle of liver cells - from stem cells and used stem cells to restore the sight in blind mice.

Last week, UK researchers warned that stem cell research aimed at finding cures for a range of crippling diseases could be jeopardised because of government plans to outlaw the creation of stem cell-rich part human, part animal 'chimera' embryos.

For kids, MS itself just half the battle

Correctly diagnosing disease can be tricky; sometimes, so is talking about it

By Judith Graham
Tribune staff reporter

December 28, 2006

Tiffany Jones stood before her classmates at Hillcrest High School, trembling. It was time to present her anatomy class project--and reveal a secret she'd closely guarded.

Eyes downcast, Jones described a high school senior with multiple sclerosis, a degenerative illness of the nervous system. "Numbness, tingling, poor balance, muscle weakness, bladder [problems] and forgetfulness" are among the girl's symptoms, she explained.

The 18-year-old "tries to stay positive because she has a lot of support from her family, friends and her church," Jones continued, her voice cracking. "[But] it makes her feel less of a person at times because she is living with a disease that she can't do anything about. Her name is--Tiffany Jones."

Jones paused, trying to keep her composure, as her classmates stared, some with their mouths open.

"There have been many nights that I sit up and cry just thinking about how I will live the rest of my life with this disease. I often wonder if I will be able to do the things I want in life," she continued, as the paper in her hand fluttered. "Will people think of me as a different person when they find out I have a disease or will they think of me as just being Tiffany?"

Until recently, multiple sclerosis was considered an adult illness. The medical community largely overlooked children with MS symptoms--a type of neglect unfortunately common for chronically ill children, especially those with relatively uncommon nervous system disorders, medical experts say.

But now, youngsters with MS are getting more attention as researchers search for the origins of this incurable illness, which strips nerves of their protective myelin coating and interferes with the brain's functioning, leading to the kind of problems Jones described to her classmates.



Diagnosis usually after puberty

As many as 10,000 U.S. children and teenagers--some as young as 5--have MS; another 10,000 to 15,000 have symptoms but can't be diagnosed with certainty, according to the National Multiple Sclerosis Society.

The youngest known patient with MS was 18 months old, but more commonly the disease surfaces after puberty when teenagers' bodies are changing and flooded by hormones.

Resources are scarce for these patients. With few exceptions, support groups are designed for adult MS patients. There are no medical guidelines for treating MS in children. None of the drugs used for adult MS patients has been tested extensively in school-age youngsters or teens. And it's still common for pediatricians and family doctors to assume children can't get the disease, making misdiagnoses routine.

"Neurologists know about this disease, but they're reluctant to treat children and adolescents because there are so many issues--dealing with school, with development, with behavioral issues, with the family," said Dr. Lauren Krupp, a neurologist who directs the National Pediatric MS Center at Stony Brook University Hospital in New York.

"And pediatricians know how to treat kids, but they don't understand MS or know anything about the medications."

Adding to the confusion, MS in youngsters is quite different than the disease in adults--so much so that researchers aren't certain if it's the same illness or a closely related variant.

For instance, in adults MS overwhelmingly afflicts white people, but at younger ages far more African-Americans, Asians and Hispanics are affected, according to Dr. John Richert, executive vice president of research and clinical programs at the National MS Society.

The disease also appears to progress more slowly in children, and "when we look at imaging studies of the brain, they look different in children with MS than adults," said Dr. Nancy Kuntz, a pediatric MS specialist at the Mayo Clinic in Rochester, Minn.

That may be because young people's brains are still developing, suggested Dr. Tanuja Chitnis, director of a pediatric MS center at Boston's Massachusetts General Hospital, noting that young people with MS appear to have more problems with processing language and visual/spatial perception.

Perhaps most puzzling is the relationship between MS and a separate condition known as acute disseminated encephalomyelitis, which afflicts children more often than it does adults. ADEM, as it's known, is an abnormal immune system response to a viral illness that typically lasts a few days or weeks but sometimes can recur.

"Often, it's hard to sort through what constitutes a bout of ADEM and what is an initial episode of multiple sclerosis in a child," said Dr. Joy Derwenskus, an assistant professor of neurology at Northwestern University's Feinberg School of Medicine. The distinction is important because treatments for the two conditions differ.

Understanding the link between viruses and MS is one of the main goals of a new network of six pediatric MS centers established by the National MS Society late last year.

Improving clinical care and support services for young people is another objective of the centers, whose Midwest location is the Mayo Clinic in Rochester, Minn.

"The biggest single problem these kids have is they don't know anyone else like them," said Maria Milazzo, a pediatric nurse practitioner at the Stony Brook MS center.



Learning to adjust

Nicole Caron was so scared after being diagnosed with MS last year at 15 that she didn't tell any of her friends what was wrong--or even admit the truth of her illness to herself. A basketball and soccer player, Nicole first felt numbness in her fingers, then extreme fatigue. Within a few months, she began getting excruciating headaches, blurred vision and pain behind her left eye.

The final diagnosis came after a brain scan and a spinal tap, but relief at knowing what was wrong was quickly followed by fear and denial.

"I didn't want to believe anything was wrong," said Nicole, who lives in North Attleboro, Mass., and is being treated at Massachusetts General Hospital. "I thought if I kept it to myself it would be all right. And I knew everyone at school would gossip, and I didn't to be the center of attention."

But the more Nicole concealed her worries, the lonelier she became. "I felt like a bad person because I wasn't telling anyone the truth," she said. After a month, she began letting friends know what was going on, but none of them had ever heard of MS.

Twice a week, Nicole left school for doctors' appointments; once, a teacher commented in class on her excused absences. "I started to cry, I was so upset," said Nicole, who gives herself daily injections of the drug Copaxone to help stall the progress of MS. Several weeks later, she disclosed her illness to the teacher.

For her mother, Judy Caron, the hardest part is accepting the unpredictability of MS, with symptoms that can come and go without warning.

"As a parent, you always try to fix everything for your children, but with this disease you have absolutely no control," she said.

In south suburban Country Club Hills, Carol Jones--Tiffany's mom--repeats a similar lament: "What's so scary about MS is, you can't tell what the future holds. You just don't know day to day what tomorrow is going to be."



Coping, with help

Tiffany's symptoms first surfaced in July 2005; after multiple visits with doctors and medical tests, a definitive diagnosis came a year later. In between, this slim dancer and pompom squad member with big, dark eyes couldn't understand why her arms and legs were going numb or why she suddenly would stumble or drop a cup.

"It makes you feel so uncertain and so afraid," said the soft-spoken girl, who started thrice weekly injections of the drug Rebif in November.

For support, Tiffany and her mom turned to a group of adults with MS who meet monthly in nearby Crete.

"It's really helpful to know what other people go through," but many of the group members are in wheelchairs and "I was thinking one day that could be me," she said.

At school, Tiffany told a few close friends about her illness early this fall but kept it concealed from other classmates and her teachers. She felt conflicted. She wanted people at school to know how her life had changed, but she didn't want to tell them.

Then, an assignment for her anatomy class became an inspiration to come forward. The teacher, by coincidence, had asked her to write a report on multiple sclerosis.

Standing before her classmates, Tiffany spoke of her fear, her faith and her confusion about what it means to stand on the edge of adulthood, trying to accept a lifelong illness.

"At times, I still feel like MS is taking over my life. I'm still struggling with that," she said. But "I have to tell myself to stop wondering what will become of me. I know that no matter what, I won't give up."

----------

jegraham@tribune.com
Copyright © 2007, Chicago Tribune

Electrical Stimulation Combats Lower Limb Paralysis

New Hope for Stroke Survivors
January 4, 2007 - 7:03 AM

BETHESDA, Md., Jan. 3 /PRNewswire/ -- Stroke is the No. 1 cause of serious disability in adults in the United States. One in seven Americans will suffer a stroke. Many stroke survivors face months of rehabilitation and a lifetime of pain and paralysis.

Now there's hope. A growing number of patients nationwide are regaining mobility thanks to a new medical device called the WalkAide that uses electrical stimulation to restore functionality to patients with paralysis.

Cleared by the FDA in September 2005 and made available in the second half of 2006, the WalkAide by Innovative Neurotronics combats a form of paralysis known as "foot drop" due to stroke, spinal cord injury, traumatic brain injury, and other pathologies such as multiple sclerosis and cerebral palsy. Nearly 10.5 million people in the United States may benefit from this new technology.

By applying low level electrical currents directly to a motor nerve in the leg, the WalkAide instructs the muscle to flex the foot so the patient can walk more normally. Contrary to traditional therapies that require the patient to spend hours in hospitals or rehabilitation facilities, the WalkAide is portable and wireless. About the size of a cell phone, the wireless device is worn around the leg, just below the knee.

A study published in the September 2006 issue of the peer-reviewed journal Neurorehabilitation and Neural Repair challenges the way we've been rehabilitating stroke survivors for years. The study identifies a trend that suggests traditional rehabilitation is stopped before patients have reached their full potential for recovery. It also suggests the WalkAide can reveal hidden potential for additional patient recovery.

Traditional programs discharge patients three months post-stroke, as it is generally accepted that a stroke survivor's potential for recovery plateaus around the twelve week mark. This leaves little hope for additional improvement after that time. However, the results of this study produced encouraging results that challenge the traditional belief.

At the traditional three month mark, when rehabilitation is typically stopped, the walking speed of patients wearing the WalkAide increased by 15%. With continued usage, patients' walking speed increased by 32% after six months and by nearly 50% after twelve months. The study also showed the number of steps taken per day by WalkAide users increased significantly over the year. WalkAide patients are seeing an increase in mobility months and years after the traditional rehabilitation programs have ended, leaving much hope for future improvements.


Contact: Jennifer Bittner, 301-280-4869

jbittner@hanger.com


Source: Innovative Neurotronics

CONTACT: Jennifer Bittner, +1-301-280-4869, jbittner@hanger.com, for
Innovative Neurotronics

Web site: http://www.walkaide.com/

Uric acid may harbour cure for central nervous system diseases

Washington, Jan. 4 (ANI): Researchers at Rutgers University, New Jersey, have for the first time discovered that uric acid can play a crucial role in the treatment of spinal cord injury and other central nervous system disorders, such as stroke, multiple sclerosis, and Parkinson's disease.

The latest findings are significant for doctors because they give additional value to the role of uric acid, which is commonly associated with the excruciatingly painful joint disease known as gout.

"In spinal cord injury, as well as stroke, two kinds of damage can occur," said Bonnie Firestein, an associate professor of cell biology and neuroscience at the university.

"First there is the physical damage, but this is followed by secondary chemical damage to neurons [nerve cells] by compounds released in response to the trauma. We have found that uric acid can promote an early intervention step in combating this chemical damage through its action on astroglial cells," she added.

Astroglial cells or astrocytes are specialized cells that support neuron function with nutrients and protective buffering.

Firestein said that their findings are interesting because many researchers had successfully observed uric acid's effects on the health of neurons, but the mechanics of how it confers protection was a mystery.

"It is interesting to note that people with gout never seem to develop multiple sclerosis," Firestein said.

"In animal models of multiple sclerosis, the addition of uric acid reduces symptoms and improves prognosis. The same is true for one type of Parkinson's disease tested," she added.

The study shows that uric acid can stimulate astroglial cells to produce transporter proteins that carry harmful compounds away from neurons in jeopardy of chemical damage, opening the door to identifying a unique drug target for new therapies.

The study has been published in the online edition of the journal Glia. (ANI)

Botox: Helping Patients Move Again

Reported January 3, 2007

DURHAM, N.C. (Ivanhoe Broadcast News) -- You've seen the results of people who look years younger after Botox injections. But Botox is turning out to be more than a fountain of youth ... It's becoming a life saver for some people battling serious illness.

Nine-year-old Andrew Carter is not afraid to fall off a horse. And he refuses to let cerebral palsy get the best of him. "I like the jumping," he says. "That's my favorite part."

When Carter tried to move, his muscles would fight him -- jerking him around. It's a condition called spasticity. Botox injections help calm his muscles. He says, "It hurts but I really do think it helps because it loosens me up."

Botulinum toxin is what causes food poisoning, but in patients like Carter, it's targeted to specific muscles.

"It causes partial paralysis in the muscle you inject it into," Orthopedic Surgeon Lewis Andrew Koman, M.D., of Wake Forest University Baptist Medical Center in Durham, North Carolina, tells Ivanhoe.

Botox is also helping stroke patients, like Ginger Hinshaw, by relaxing muscles. Before Botox, Hinshaw could barely move after her stroke. "My left hand -- if it's not in this splint, my fingers will just be in a knot," she says.

Today, Hinshaw is able to write about what happened to her. She says, "I have a lot of exercises and stretches to do at home to get me ready for my next phase of recovery."

Wake Forest Neurologist Allison Brashear, M.D., says there's no risk -- and patients can take it again and again and again. "The beauty of the drug is that you put the Botox in the arm, and it just stays there."

Botox is also being used to help multiple sclerosis patients and patients with traumatic brain injuries. Injections need to be repeated about every four to six months. There are no known side effects.

This article was reported by Ivanhoe.com, who offers Medical Alerts by e-mail every day of the week. To subscribe, go to: http://www.ivanhoe.com/newsalert/.

If you would like more information, please contact:

Karen Richardson
Public Relations
Wake Forest University Baptist Medical Center
(336) 716-4453

UTEK Corporation and NeoStem, Inc. Announce Strategic Alliance

TAMPA, Fla. & NEW YORK--(BUSINESS WIRE)--Jan 4, 2007 - UTEK Corporation (AMEX:UTK) (LSE-AIM:UTK), a specialty finance company focused on technology transfer, and NeoStem, Inc. (OTCBB:NEOI), a provider of adult stem cell collection, processing and storage services, today announced that they have signed a strategic alliance.

"NeoStem, Inc. is pleased to execute this strategic alliance with UTEK in moving forward to expand our proprietary position in the adult stem cell collection and storage arena as well as the burgeoning field of regenerative medicine," said Dr. Robin Smith, M.D., M.B.A., Chief Executive Officer of NeoStem, Inc. The Company is focused on providing adults with a bio-insurance product - "your adult stem cells for your use".


"UTEK looks forward to working with NeoStem, Inc. to identify potential technology acquisition opportunities that fit its strategic vision," commented Clifford Gross, Ph.D., Chief Executive Officer of UTEK Corporation.

Through its strategic alliance agreements, UTEK assists companies in enhancing their new product pipeline with the acquisition of proprietary intellectual capital from universities and laboratory research centers. Strategic alliance agreements are generally cancelable by either party with thirty days advance written notice.

About NeoStem, Inc.

NeoStem, Inc. is a publicly traded company positioned to become a leader in the adult stem cell field and to capitalize on the increasing importance that adult stem cells are expected to play in the future of regenerative medicine. Using its proprietary process, NeoStem provides the infrastructure, methods and systems that allow adults to have their stem cells safely collected and conveniently banked for future therapeutic use, as needed, in the treatment of such life-threatening diseases as diabetes, heart disease and radiation sickness that may result from a bio-terrorist attack. Adult stem cell therapy has also been used for many years in treating blood cancer. Further potential uses include regenerative therapies for wound healing, autoimmune diseases such as multiple sclerosis and lupus, and age-related degenerative musculoskeletal diseases. For more information about NeoStem, Inc., please visit its website at www.neostem.com.

About UTEK Corporation

UTEK(R) is a specialty finance company focused on technology transfer. UTEK's services enable companies to acquire innovative technologies from universities and research laboratories worldwide. UTEK facilitates the identification and acquisition of external technologies for clients in exchange for their equity securities. This unique process is called U2B(R). In addition, UTEK offers companies the tools to search, analyze and manage university intellectual properties. UTEK is a business development company with operations in the United States, United Kingdom and Israel. For more information about UTEK, please visit its website at www.utekcorp.com.

Forward-Looking Statements

Certain matters discussed in this press release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements can generally be identified as such because the statement includes words such as "expects," "should," "believes," "anticipates" or words of similar nature. Similarly, statements that describe UTEK's or NeoStem's future plans, objectives or goals are also forward-looking statements. Such forward-looking statements are subject to certain known and unknown risks and uncertainties, including the financial performance of UTEK or NeoStem, the valuation of UTEK's investment portfolio, the identification of appropriate technology acquisition opportunities for NeoStem and the execution on such opportunities, which could cause actual results to differ materially from those currently anticipated. Although UTEK and NeoStem believe the expectations reflected in any forward-looking statements are based on reasonable assumptions, they cannot give any assurance that their expectations will be attained. Shareholders, potential investors and other readers are urged to consider these factors carefully in evaluating any forward-looking statements. Certain factors could cause results and conditions to differ materially from those projected in these forward-looking statements, and some of these factors are discussed below. These factors are not exhaustive. New factors, risks and uncertainties may emerge from time to time that may affect the forward-looking statements made herein. These forward-looking statements are only made as of the date of this press release and neither UTEK nor NeoStem undertake any obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

UTEK's operating results could fluctuate significantly due to a number of factors. These factors include the small number of transactions that are completed each quarter, the value of individual transactions, the timing of the recognition and the magnitude of unrealized gains and losses, UTEK's dependence on the performance of companies in its portfolio, the possibility that advances in technology could render the technologies it has transferred obsolete, the loss of technology licenses by companies in its portfolio, the degree to which it encounters competition in its markets, the volatility of the stock market and the volatility of the valuations of the companies it has invested in as it relates to its realized and unrealized gains and losses, the concentration of investments in a small number of companies, as well as other general economic conditions. As a result of these and other factors, current results may not be indicative of UTEK's future performance. For more information on UTEK and for a more complete discussion of the risks pertaining to an investment in UTEK, please refer to UTEK's filings with the Securities and Exchange Commission.

NeoStem's ability to enter the adult stem cell arena and future operating results are dependent upon many factors, including but not limited to (i) the Company's ability to obtain sufficient capital or a strategic business arrangement to fund its expansion plans; (ii) the Company's ability to build the management and human resources and infrastructure necessary to support the growth of its business and obtain appropriate state licenses; (iii) competitive factors and developments beyond the Company's control; (iv) scientific and medical developments beyond the Company's control; and (v) other risk factors discussed in the Company's periodic filings with the Securities and Exchange Commission which, are available for review at www.sec.gov under "Search for Company Filings."

Contact

UTEK Corporation, Tampa
Tania Bernier, 813-754-4330 x 223 (USA)
or
Consulting for Strategic Growth 1
Stan Wunderlich, 800-625-2236
or
Bankside Consultants (UK)
Steve Liebmann or Simon Bloomfield, + 44 (0) 20-7367-8883
or
Neostem, Inc.
Robin Smith, M.D., M.B.A., 212-584-4180

Contrasting Roles for Axonal Degeneration in an Autoimmune versus Viral Model of Multiple Sclerosis

(American Journal of Pathology. 2007;170:214-226.)
© 2007 American Society for Investigative Pathology
DOI: 10.2353/ajpath.2007.060683

When Can Axonal Injury Be Beneficial?

Ikuo Tsunoda, Tomoko Tanaka, Emily Jane Terry and Robert S. Fujinami
From the Department of Neurology, University of Utah School of Medicine, Salt Lake City, Utah


Although demyelination is a cardinal feature in multiple sclerosis, axonal injury also occurs. We tested whether a delay in axonal degeneration could affect the disease severity in two models for multiple sclerosis: experimental autoimmune encephalomyelitis (EAE) and Theiler’s murine encephalomyelitis virus (TMEV) infection. We compared wild-type C57BL/6 (B6) mice with C57BL/Wlds (Wld) mice, which carry a mutation that delays axonal degeneration. In EAE, both mouse strains were sensitized with myelin oligodendrocyte glycoprotein (MOG)35-55 peptide and showed a similar disease onset, MOG-specific lymphoproliferative responses, and inflammation during the acute stage of EAE. However, during the chronic stage, B6 mice continued to show paralysis with a greater extent of axonal damage, demyelination, and MOG-specific lymphoproliferative responses compared with Wld mice, which showed complete recovery. In TMEV infection, only Wld mice were paralyzed and had increased inflammation, virus antigen-positive cells, and TMEV-specific lymphoproliferative responses versus infected B6 mice. Because TMEV can use axons to disseminate in the brain, axonal degeneration in B6 mice might be a beneficial mechanism that limits the virus spread, whereas slow axonal degeneration in Wld mice could favor virus spread. Therefore, axonal degeneration plays contrasting roles (beneficial versus detrimental) depending on the initiator driving the disease.

Eye Center Detecting MS In Early Stages

07:12 PM, January 2nd 2007
by News Staff

Doctors in Houston are looking into their patients' eyes to search for early signs of multiple sclerosis.

Using four different and inexpensive eye exams, physicians at the Multiple Sclerosis Eye Center for Analysis, Research and Education search for abnormalities in the retina and damage to optic nerve fibers. Many doctors agree that, in more than half of patients, the neurological disorder first attacks the eyes, causing blurred vision, and temporary or permanent sight loss, the Wall Street Journal said Tuesday.

By concentrating on the eyes, "the center is helping patients identify irregularities and referring them for treatments that may slow the disorder's progression," says Rosa Tang, co-director at MS Eye Care.

No one test can either diagnose or eliminate MS, doctors said. Several tests, such as an MRI or a spinal tap, both expensive, are needed for a thorough diagnosis.

A number of doctors are pushing for more centers similar to MS Eye Care, based on its capability of early detection at a lower cost.


© 2007 UPI

New rules for Chinese meds

Wed, January 3, 2007

Regulation not endorsement, province says

By MEGAN GILLIS, OTTAWA SUN


Practitioners of traditional Chinese medicine are welcoming government regulation of their 5,000-year-old art.

It's a move the Liberal government says will ensure the treatments do no harm.

But a skeptic argues legislators are giving the mistaken impression the treatments have been proven to help.

Joanne Pritchard-Sobhani, a doctor of traditional Chinese medicine (TCM), argues Ontario's move to create a self-regulating college for her profession brings the therapy into the mainstream and protects patients.

"To increase standards of education and practice is the most important thing," said Pritchard-Sobhani, who has a dozen years of education in China, Sri Lanka and North America.


"Anyone in Ontario could practise acupuncture or Chinese medicine without being qualified. They could hang out a shingle.

"People can be assured now that practitioners can diagnose and have effective and safe treatments."

She touts TCM for treating everything from multiple sclerosis to cancer and argues regulating it amounts to an endorsement by Minister of Health George Smitherman.

"He's endorsing traditional Chinese medicine as a legitimate health-care profession alongside physiotherapists, chiropractors and doctors," she said.

Traditional Chinese medicine is based on the belief that illnesses are caused by imbalances in qi -- the life force in all living things. TCM practitioners use acupuncture, diet, exercise, massage and herbs -- along with cupping, applying hot inverted cups to the skin, and moxibustion, or burning herbs above points on the body.

Minister of Health George Smitherman argued that regulating TCM will ensure Ontarians who choose it get "safe, quality" care.

The government didn't try to judge whether it works -- only that a therapy more and more Ontarians are using is safe, spokesman David Spencer said.

"It was not for us to make a judgement on its level of effectiveness -- only to say these practices are in use," he said. "Our role as government is to ensure when people are using these practices no harm is done in the process."

But the group Canadians for Rational Health Policy argues that TCM is an unproven method that can leave patients poorer and sicker.

The studies proponents cite to prove therapies such as acupuncture work are usually poorly designed, argues psychologist Dr. Barry Beyerstein, who studies why people believe in what he calls bogus therapies.

He argues they can be useless but far from harmless, citing herbs that can cause liver damage and infections and perforated organs in botched acupuncture.

Beyerstein sent his diabetic brother to a dozen random TCM practitioners.

Despite his MedicAlert bracelet and classic symptoms, none diagnosed diabetes and some prescribed sugary remedies.

Beyerstein has mixed feelings about Ontario's move.

"On the one hand, it gives government imprimatur to some bad science," he said. "On the other hand, it puts some of the worst practitioners out of business."

$5 Million Gift Establishes Judith Jaffe Multiple Sclerosis Unit At Weill Cornell Medical College

The Feil Family Foundation, with matching funds from the Dean's Challenge, has pledged $5.33 million to establish the new Judith Jaffe Multiple Sclerosis Unit at Weill Cornell Medical College in New York City. The Unit is named for Gertrude and Louis Feil's daughter Judith Jaffe.

The gift will also endow two Feil Family Clinical Scholar Awards in Multiple Sclerosis to recognize outstanding research and treatment.

Scheduled to open later this month, the Jaffe Multiple Sclerosis Unit will be located in Weill Cornell Medical College's historic new Ambulatory Care and Medical Education Building on York Ave. and 70th Street.

"The Feils have been faithful supporters of the Medical College for more than 20 years. Jeffrey J. Feil has been a valued member of our Board of Overseers since 2003, and his counsel and vision have been invaluable. With this generous gift, he continues to lead by example," says Sanford I. Weill, chairman of Weill Cornell's Board of Overseers.

Dr. Antonio M. Gotto Jr., Stephen and Suzanne Weiss Dean of Weill Cornell Medical College, adds, "The new unit will further enhance our esteemed Multiple Sclerosis Clinical Care and Research Center, and offer patients access to the benefits of the latest research and highest quality patient care in multiple sclerosis."

"In addition to its national reputation for excellence in multiple sclerosis, Weill Cornell is well known for clinical and research excellence in all areas of medicine. Our family is very grateful for the care given by the Medical College and the Department of Neurology to my late father, Louis, late mother Gertrude, and our family," says Mr. Jeffrey Feil, president of the Feil Family Foundation.

The program is directed by Dr. Brian Apatoff, a nationally recognized authority in MS treatment and research, who says, "The Feil family's gift secures urgently needed expanded space in the new state-of-the-art Ambulatory Care and Medical Education Building. With the opening of the new unit and its additional staff, we expect patient visits to more than double."

Dr. Apatoff is also associate professor of neurology and neuroscience at Weill Cornell Medical College and associate attending neurologist at NewYork-Presbyterian Hospital/Weill Cornell Medical Center.

The Multiple Sclerosis Clinical Care and Research Center offers diagnosis and treatment options to patients with multiple sclerosis, optic neuritis and other autoimmune, inflammatory demyelinating disorders of the central nervous system. Recognized by the National Multiple Sclerosis Society, the Center provides the latest treatments for the disease, including approved and novel investigational therapies. The program is dedicated to providing comprehensive patient care in a comfortable patient- and family-friendly environment. The Center will employ a coordinated multidisciplinary approach of relevant clinical departments - including designated specialists from neurology, neuro-ophthalmology, nutrition, urology, psychiatry, rehabilitative medicine, physical and occupational therapy, and clinical social work services.

"For the first time in medical history, we're able to control the disease, limit the frequency and severity of attacks, and limit the neurologic disability that would otherwise accumulate over time," says Dr. Apatoff. "It's a lifelong condition, but if you control it at the earliest stages, keep it mild, then the long-term outcomes are greatly improved."

The Center is pursuing innovative research, including immune-modulatory therapies and ways to inhibit gene expression of the "bad lymphocytes" considered to be the disease's main culprit. "We're trying to understand the primary mechanisms of the disease, the immunologic components that determine the patient's course," Dr. Apatoff continues. "We want to selectively identify and control aberrant immune responses, as opposed to older therapies that globally suppress the immune system and have all sorts of complications and side effects."

The Center is relatively unusual in that it not only serves a large patient population and conducts research but also trains residents from both NewYork-Presbyterian/Weill Cornell and NewYork-Presbyterian Hospital/Columbia University Medical Center.

With views over the courtyard to the south adding to the relaxing feel of the comfortable, inviting reception area, the Jaffe Multiple Sclerosis Unit will consist of patient examination rooms; doctors' offices; an infusion room; and a support suite for nurse practitioners, a social worker, clinical trials coordinator and compliance coordinator.

The Feil family has funded the Multiple Sclerosis Clinical Care and Research Center since 2000, when they established the Louis and Gertrude Feil Professorship of Clinical Neurology in honor of Dr. John Caronna. In addition, the family has long supported the initiatives, programs and people of Weill Cornell, including endowment of The Judith Jaffe Multiple Sclerosis Fund, The Yvette and Seymour Feil Prize in Medicine, The Louis and Gertrude Feil Professorship of Medicine, The Gertrude and Louis Feil Scholarship Fund, and most recently, a substantial contribution to the Friends' Fund of Dr. R.A. Rees Pritchett.

Multiple Sclerosis

An estimated 400,000 Americans suffer from multiple sclerosis (M.S.). It generally first occurs in people between the ages of 20 and 50, more commonly in women, causing inflammation in the white matter of the central nervous system. It can ultimately destroy myelin, the protective sheathing that insulates and protects nerve cell fibers in the brain, optic nerve and spinal cord. Unchecked, M.S. can be very debilitating, with the nerve damage causing bladder and bowel disorders, cognitive and memory problems, visual disturbance, sexual dysfunction, depression and other symptoms. The exact cause is not known, but the disease appears to be initiated when the immune system mistakes the body's own myelin as a foreign substance.

Weill Cornell Medical College

Weill Cornell Medical College - located in New York City - is committed to excellence in research, teaching, patient care and the advancement of the art and science of medicine. The Medical College, which is a principal academic affiliate of NewYork-Presbyterian Hospital, offers an innovative curriculum that integrates the teaching of basic and clinical sciences, problem-based learning, office-based preceptorships, and primary care and doctoring courses. Physicians and scientists of Weill Cornell Medical College are engaged in cutting-edge research in such areas as stem cells, genetics and gene therapy, geriatrics, neuroscience, structural biology, cardiovascular biology, AIDS, multiple sclerosis, cancer and psychiatry - and continue to delve ever-deeper into the molecular basis of disease in an effort to unlock the mysteries behind the human body and the malfunctions that result in serious medical disorders. Weill Cornell Medical College is the birthplace of many medical advances - from the development of the Pap test for cervical cancer to the synthesis of penicillin, the first successful embryo-biopsy pregnancy and birth in the U.S., and most recently, the world's first clinical trial for gene therapy for Parkinson's disease. Weill Cornell's Physician Organization includes 650 clinical faculty, who provide the highest quality of care to patients.

Joan and Sanford I. Weill Cornell Medical College
http://www.nyp.org

Balance training helps overcome MS symptoms

LEE NOBLE
The Herald Bulletin

ANDERSON, Ind. -- Susan Townsend's walker sits in the corner of the classroom where she teaches fifth grade in Summitville.

It used to help her walk, but she hasn't needed it lately.

"It's more of a bookshelf now than anything else," Townsend said.


Townsend used the walker for about four months earlier this year after she began chemotherapy treatments for multiple sclerosis. She was diagnosed in 1987, when she was just 18, and her condition worsened to the point where she needed a walker this year before age 40.

But she doesn't need it now. She credits St. John's Regional Balance Center for her improvements. Her therapist at the balance center credits new techniques and equipment made to retrain the body's senses to work together better, letting patients like Townsend regain their balance and independence.

Patients unlike Townsend may benefit, too, according to Brock Haut, her physical therapist at the balance center.

"We get 20-year-olds to 90-year-olds," he said.

They come in with problems like dizziness, vertigo and loss of balance.

Some common causes for dizziness are inner ear infections and injuries to the inner ear after head trauma. Common causes for balance problems are inactivity, Parkinson's Disease, MS and orthopedic problems.

Therapists make assessments of the patients they see based on a variety of tests, then ask a question -- will treatment help?

"If the person can't be helped, we talk to the family and caregivers about safety strategies to prevent falls," Haut said.

If he thinks treatment may help, he'll give the patient a therapy plan.

Townsend's plan was simple. She practiced. She walked around things, walked while looking up, then while looking down. She took strides with resistance from a weight machine and did "ball hand-offs," moving a ball between her hands at different positions.

She also sat down, and stood up, and sat down, and stood up.

"When I read the exercises, I thought they were silly, simple exercises, but when I tried them, they were really challenging," she said.

So challenging, in fact, she had to endure some pain.

"I had to walk on my tiptoes and heels," said Townsend who, with MS, doesn't have steady legs. "Oh my gosh, that hurts."

But whatever pain she withstood paid off, letting her move more easily than she has in years.

All it took was a referral from her doctor and a few visits a week with a therapist at the balance center.

Because of the complexity of the human body's balancing act, not all balance problems are the same.

"In a normal, healthy individual, the senses of touch, position, vision and inner ear motion sensors work together with the brain," said Haut, who has extensive training in balance rehabilitation. "If you have a balance disorder, however, you may have a problem in any one or combination of these systems."

The balance center, located in Carl D. Erskine Rehabilitation Center on St. John's campus, has several tools to help pinpoint what's causing balance problems.

Once the staff members get to know the patient, they can add exercises designed especially to meet the patient's needs.

For Townsend, they practiced household chores, like some she does at home, at the clinic.

While the therapy helped Townsend leave behind her walker, it can help others quit prescription drugs (under the supervision of their physicians) and solve months of confusion and misdiagnosis, Haut said.

Fifty-three months usually pass from a person's initial dizziness or balance complaint to a personal physician until a proper diagnosis and treatment is undertaken at a place like the balance center, Haut said. Misdiagnosed problems and prescription drugs that offer only temporary solutions to the problems contribute to that length of time.

It is estimated that as many as 40 percent of adults have problems with dizziness or imbalance that are severe enough to report to a doctor, according to the balance center. For some, balance problems can cause severe disruptions in daily life, making people unsteady and causing the elderly to fall.

In addition to the risk of falling, these disorders can shorten attention span, disrupt normal sleep patterns and cause excessive fatigue, according to a balance center spokesman.

"Problems with dizziness or lack of balance are often dismissed as being unimportant, or as simply an unavoidable part of growing older," Haut said.

It usually takes a few visits a week for a few months until patients take full benefit from therapy.

Doctors believe a common cause for balance problems may be lack of physical activity, something common in the elderly as well as many younger people.

Townsend, who lives on farmland in Gaston with her husband and 16-year-old daughter, prefers to be active, she says. But because her MS symptoms fluctuate, she has had trouble getting into a routine, leaving her with some insecurities.

"When I fell before, I didn't know why I fell -- I just lost balance and fell," Townsend said.

The therapy with Haut has reduced those falls, giving the school teacher the wherewithal to do the things she used to do confidently.

Townsend calls it retraining the brain.

"I live in the country. I have a clothesline. I put clothes on the line this summer for the first time in two years," Townsend said. "I think it's retrained my brain to do those simple things."

Distributed by The Associated Press

Trainers see benefits in very slow exercise

By Lisa Roberts
THE ORLANDO SENTINEL
ORLANDO, Fla. - Exercise has slowly -- very slowly -- changed Jan Love's life.

After breaking her neck and arm in an automobile accident, the 80-year-old Orlando, Fla., woman was determined to recover. She underwent physical therapy, but the exercises she learned failed to help restore much neck mobility.

Frustrated, Love decided to try SuperSlow training, which she had seen advertised in a newspaper. Less than a year later, she can move her head and neck freely. "I have a few kinks here and there," she says, "but this keeps me going."

At the SuperSlow Zone Research Center in Altamonte Springs, Fla., Love and other clients work out with a trainer in sessions of 30 minutes or less using four to six machines, each of which targets a group of muscles. The workouts might look a lot like a traditional weight-training session, but speed makes the difference in SuperSlow. Repetitions are done at a crawl, with weights raised and lowered in 10-second phases until the targeted muscles reach "momentary muscular failure." Then exercisers push on for an extra 10 seconds, which serves to build lean muscle.

In contrast, traditional lifting usually is executed at a speed of about two seconds up and four seconds down, says Dr. John Dobson, who teaches exercise physiology at the University of Florida in Gainesville.

Less risk of injury

The SuperSlow training regimen was developed by Ken Hutchins and his wife, Brenda, based on their observations during a 1982 osteoporosis study at the University of Florida. Although the study was unfinished, they observed that slow, less-numerous repetitions could build lean muscle without the risk of injury associated with traditional and high-velocity weight-training methods. Since developing the program, they have trained clients of all ages, including those with Parkinson's disease, multiple sclerosis and diabetes.

The brief workouts, performed on specially designed Nautilus equipment under supervision of a trainer, can be done once or twice a week to achieve results, Hutchins says.

That's plenty, says Love, who has slowly increased her strength, stamina, range of motion and stability under Hutchins' coaching. "I work hard with Ken. If you don't crawl out to your car (after a session), you haven't worked hard enough."

How she does it

Love has been training with Hutchins for more than a year, and from the looks of it, the workout's reputation for being intense is well deserved. She reclines slightly, knees bent, on a leg-press machine, the soles of her feet flat against the vertical platform in front of her. Then Hutchins fastens and tightens a web belt around her upper thighs.

"Moderate pressure," he instructs. Love presses against the belt with her thighs as if determined to break through it. Then Hutchins kicks it up a notch. "Almost as hard as you dare," he urges Love, who begins to perspire and breathe hard from the exertion. A few seconds later, he asks for even more. "As hard as you dare," he orders crisply. Love responds by pressing against the belt so hard that it leaves grooves in her skin when Hutchins removes it.

After the isometric exercises, Love slowly presses back with her legs, making the seat of the machine glide backward. At the count of 10, she arrives at the top of her range, then takes 10 more seconds to slide back. After completing a handful of repetitions, she climbs off the machine and moves to the next.

Less than 20 minutes and four machines later, she's finished. "My knees are buckling," she says with a laugh.

The jury is out

Research into the advantages of such training is scant and unstandardized, with studies often yielding contradicting findings.

"We do know that slow motion can enhance your strength," UF's Dobson says. "We just don't know if it's better than traditional lifting. Unfortunately, it's very difficult to get a consensus out of the (limited) studies. ... There's still a lot we don't know."

Not for everyone

Slow training might not be for everyone. "You really have to train in a way that is comparable to the desired outcome," Dobson says.

For instance, an Olympic weightlifter would train with speed. "You won't be able to lift the weight if you don't do it quickly."

On the other hand, because slow lifting enhances stability, the elderly especially stand to reap its benefits.

The bottom line: "I would say the most important thing to do is to be physically active. If getting into SuperSlow is fun and you're active, if you find it's your particular preference to get involved in and exercise, then you should do whatever it takes."

For Love, there's no question that slow is the way to go. "It'll never be perfect," she says of her neck, "but every day is gravy."

SuperSlow fans say intense, brief workouts build muscle and burn calories efficiently.