Friday, March 30, 2007

Critical Outcome Technologies Inc. Provides Update on Multiple Sclerosis Library

Mar 30 2007, 6:03 AM EST



Critical Outcome Technologies Inc. (TSX VENTURE: COT), provided an update to the market today on its Multiple Sclerosis (MS) Library.

Critical Outcome Technologies Inc. (COTI) has been monitoring the synthesis of its first four MS compounds through regular meetings with its synthetic chemistry partner, Dalton Pharma Services (Dalton). "The COTI MS compounds are novel and therefore have not been made before. Each of the first four COTI MS compounds has required the research and development of some entirely new chemistry. As a result, this new chemistry will strengthen our patent position and add to the value realized by future customers" said Dr. Wayne Danter, President and Chief Scientific Officer of COTI.

Dalton has manufactured small amounts of the lead MS compound COT601-M06.1, but has encountered difficulty with scaling up production. Dalton will continue its work synthesizing the lead MS compound COT601-M06.1 and is confident that they will be successful in scaling up production.

Since the November 2006 start of the MS molecule synthesis, COTI has broadened its synthetic chemistry resource base in recognition of the complexity and issues surrounding compounds requiring new chemistry. Delmar Chemicals (Delmar)of Montreal has consulted since February 2007 to synthesize the second two MS compounds starting with the lead MS compound COT604-M06.2. Delmaris also confident that hey will be successful in scaling up production.

"COTI together with our synthetic chemistry partners remain confident that these novel compounds will be successfully synthesized in the near future" said Dr. Wayne Danter. "We will continue our pursuit of seeking an effective treatment for acute MS and we will remain focused on engaging prospective partners and customers with this library of novel, optimized lead compounds."

About Critical Outcome Technologies Inc.

COTI is formed around a unique computational platform technology called CHEMSAS(R), which allows for the accelerated identification, profiling and optimization n of targeted small molecules potentially effective in the treatment of human diseases for which current therapy is either lacking or ineffective. COTI's business is focused on the discovery and pre-clinical development of libraries of novel, optimized lead molecules for the treatment of specific cancers, HIV and multiple sclerosis. Currently, five targeted libraries of lead compounds (small cell lung cancer, multiple sclerosis, HIV integrase inhibitors, colorectal cancer, and acute myelogenous leukemia in adults) are under active development.

The TSX Venture Exchange does not accept responsibility for the adequacy or accuracy of this release.

Critical Outcome Technologies Inc.
Dr. Wayne Danter
President & CSO
(519) 858-5157

Critical Outcome Technologies Inc.
Michael Barr
Director of Marketing & Business Development
(519) 858-5157

SOURCE: Critical Outcome Technologies Inc.

MS patients need better socio-economic support as well as medical care

Housing and transport prove key issues

People with multiple sclerosis need much more practical help and better care support, according to a study published in the latest Journal of Advanced Nursing.

Researchers from King’s College London explored the aspirations of 445 patients with different levels of multiple sclerosis (MS), who were taking part in a wider study to evaluate MS specialist nurses.

They believe that their findings could form the basis for developing an MS satisfaction tool, which could be used to assess quality of care in services.

The tool could also identify the gaps in provision that still exist despite the MS guidelines issued by the National Institute for Health and Clinical Excellence, which advises the UK Government on health issues.

29 per cent of those who took part in the survey said that medical treatment was their number one priority when it came to meeting their current needs, but 19 per cent specified socio-economic support, with 67 per cent of those specifying household adaptations, better transport provision and re-housing.

The need for help with financial and employment problems was also identified.

A further 18 per cent pointed to the need for enhanced care provision, including improvements in the availability, accessibility and continuity of health and social care provision.

Respondents felt health care professionals needed greater knowledge about MS and how to manage it and wanted better co-ordinated services with one central point of contact. They also felt that specialist MS nurses had an important role to play.

Nine per cent of respondents wanted more information about MS treatments and services and some felt that families and society needed to improve their understanding of MS and how it affects people.

Seven per cent wanted better access to rehabilitation therapies, notably physiotherapy. Occupational therapy and rehabilitation therapies were also mentioned.

Six per cent wanted non-professional care – including support with personal, home and child care – and a further three per cent needed help with psychological issues.

"The aim of the study was to identify what people with MS needed most and to compare the responses between people with different levels of MS" explains lead researcher Dr Angus Forbes.

"People with minimal levels of MS rated medical treatment as their highest priority, followed by enhanced care, as did people with severe MS.

"Patients with mild MS also rated medical care first, with socio-environmental help and enhanced care in joint second place. But people with moderate MS, rated medical care in second place behind socio-environmental help."

The 714 people taking part in the wider MS study were recruited from seven neurological centres across five English regions.

435 responded to the question "What one thing would be most helpful in meeting your current needs" in the first questionnaire and 424 responded to the question in the second survey a year later. 270 people answered the question on both occasions.

The average age of the respondents was just over 48 and 69 per cent were female. Average time since diagnosis was just over 11 years and 83 per cent of respondents lived with others.

60 per cent had progressive MS, 29 per cent had relapse-remitting MS. Other forms of MS accounted for 11 per cent of the sample.

More than one in three had moderate MS (35 per cent), followed by severe (28 per cent), mild (20 per cent) and minimal (17 per cent).

"Since our research was carried out, the UK’s National Institute for Health and Clinical Excellence has produced MS care guidelines which seem to echo the aspirations expressed by the MS patients who took part in our study. But a 2006 study suggested that little had changed, with few health authorities implementing the guidelines" says Dr Forbes.

"Such deficits are not confined to the UK and have been reported in wider surveys across Europe."

"Our survey, which was funded by the MS Society for Great Britain, shows very clearly that people’s needs change as their MS develops.

"Developing a needs assessment tool specifically for MS would be an important first step in ensuring that healthcare meets those individual and changing needs, as it would show how well care is currently being provided, identify gaps in provision and point to areas for future research."

Notes to editors

What people with multiple sclerosis perceive to be important to meeting their needs. Forbes et al. Journal of Advanced Nursing. 58.1, 11-22.

Journal of Advanced Nursing is read by experienced nurses, midwives, health visitors and advanced nursing students in over 80 countries. It informs, educates, explores, debates and challenges the foundations of nursing health care knowledge and practice worldwide. Edited by Professor Alison Tierney, it is published 24 times a year by Blackwell Publishing Ltd, part of the international Blackwell Publishing group.

Blackwell Publishing is the world’s leading society publisher, partnering with 665 medical, academic, and professional societies. Blackwell publishes over 800 journals and has over 6,000 books in print. The company employs over 1,000 staff members in offices in the US, UK, Australia, China, Singapore, Denmark, Germany and Japan and officially merged with John Wiley & Sons, Inc's Scientific, Technical and Medical business in February 2007. Blackwell’s mission as an expert publisher is to create long-term partnerships with our clients that enhance learning, disseminate research, and improve the quality of professional practice. For more information on Blackwell Publishing, please visit or

King's College London is the fourth oldest university in England with approximately 13,700 undergraduates and 5,600 graduate students in nine schools across five London campuses. The College has had 24 of its subject-areas awarded the highest HEFCE rating of 5* and 5 for research quality and it is home to five Medical Research Council Centres. King's has a particularly distinguished reputation in the humanities, law, social sciences, natural sciences, biomedicine and nursing and has played a major role in many of the advances that have shaped modern life, such as the discovery of the structure of DNA.

Contact: Annette Whibley
Blackwell Publishing Ltd.

Wednesday, March 28, 2007

Think herbal supplements are safe?

People are mixing supplements, herbs and over-the-counter medications and prescription drugs to cure themselves of ills, unaware that they could be making themselves sicker, says George Grossberg, M.D., director of the division of geriatric psychiatry at Saint Louis University.

Dr. Grossberg is about to change all that. He is the co-author of a new book, "The Essential Herb-Drug-Vitamin Interaction Guide," which is a comprehensive listing of what various herbs and supplements do, possible side effects and how they might interact with other medications and foods.

"People think if it doesn't require a prescription, it's got to be safe, and that's not true. There could be life-thr eatening effects."

Dr. Grossberg first became interested in the topic after a routine six-month visit with a patient he had successfully treated for depression. He had been seeing the patient for four or five years, and asked if the man was dealing with any new health problems.

The patient mentioned that he was scheduled to go in for cystoscopy in a couple weeks because there had been blood in his urine. The procedure involves inserting the pencil-thin tip of a probe through the urethra, up to the bladder to detect the cause of the problem.

The patient had undergone thousands of dollars of MRIs and CAT scans of his lower abdomen and pelvis, which had not revealed the reason for the bleeding, and the test was the next diagnostic step.

Dr. Grossberg asked if the patient had changed anything – perhaps had started taking a new medication.

No new medicine. Then the patient's wife pulled from her purse a vial containing a supplement she had purchased from the health food store to enhance memory. Both husband and wife had started taking the herbal memory enhancer, which largely contained ginkgo biloba.

"One of the side effects of ginkgo biloba is an increased risk of bleeding. He had no awareness of this. I told him to stop taking the herb and get rechecked before having cystoscopy. The bleeding stopped, and he didn't need the test."

Dr. Grossberg ticks off other common herbs that people take without realizing their side effects or how they might interact with medications.

St. John's wort sometimes is taken for anxiety and depression. Those who also are taking antidepressants or anti-anxiety medications, such as Prozac, Zoloft or Paxil, should beware. Mixing St. John's wort with these medicines can cause serotonin syndrome -- with symptoms that may include agitation, rapid heart beat, flushing and heavy sweating -- that may be fatal.

Dong quai, which some women take for menstrual disorders and to ease symptoms of menopause, has been linked to cardiovascular problems, such as irregular heart rhythm and low blood pressure. If a patient takes the herb along with an antihypertensive drug, her blood pressure could plummet, putting her at risk of stroke.

Some people take echinacea, which enhances the immune system, for the common cold. However, those who also take Lipitor, Celebrex and Aleve face an increased risk of liver damage. Echinacea also can be harmful for those who have multiple sclerosis, diabetes, HIV infections or allergies.

Dr. Grossberg and his co-author Barry Fox make it clear that they're not anti-herb or anti-medicine.

"There just are a lot of things people can take that have a lot of bad interactions. And on some level it makes sense for them to think that what they're doing is safe. They associate natural remedies with nature and think if the supplement wasn't safe, they couldn't pick it up without a prescription.

"Hopefully this will get them to think more about it so they look before they leap. People can look up what they're thinking of taking and see if there's efficacy. And they should always talk to their doctor about everything they're taking."

Many doctors don't know much about herbal remedies, which have been used as medications for thousands of years.

"When I trained, there was nothing like this in our medical education," says Dr. Grossberg, who graduated from medical school in 1975. "The younger doctors are more likely to know this than older doctors."

Elderly people, he says, use herbal remedies and don't always tell their doctors and pharmacists. They should.

"A lot of our older patients are buying herbals and botanicals. In addition, while those over 65 represent about 14 percent of the population, they consumer 40 percent of over-the-counter medications," he says.

The book, published by Broadway Books, a subsidiary of Random House, is being released in mid-April.

New Oral Agents for Multiple Sclerosis, Including Novartis/Mitsubishi Pharma's Novel Drug, Will Capture 25% of Market Share by 2020

Concerns Over Safety and Efficacy Will Prevent Emergence of a Blockbuster Drug Through 2020, According to a New Report from Decision Resources

WALTHAM, Mass., March 28 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that emerging oral therapies for multiple sclerosis, including a new drug from Novartis/Mitsubishi Pharma, will capture 25% of the market share by 2020 in the United States, Japan, France, Germany, Italy, Spain, and the United Kingdom.

The new Pharmacor report Multiple Sclerosis 2005-2020: Will Emerging Oral Agents Unseat Current Therapies? finds that Novartis/Mitsubishi Pharma's new agent, currently known as fingolimod (also called FTY-720) will outperform other emerging therapies because of its oral formulation, superior efficacy, and acceptable safety profile, although experts temper
their excitement with caution because the drug's side-effect profile has not yet fully emerged.

Physicians' and experts' wariness concerning drug safety was prompted by the development of serious infections (three of which proved fatal) in five patients who received Biogen Idec/Elan's Tysabri, which launched in the U.S. market in 2004. For safety concerns, Tysabri was pulled from shelves in 2005 -- following a safety review, the drug was re-approved by the Food and Drug Administration in 2006.

"The history of serious side effects associated with Tysabri has not only impaired its once-promising market potential but also negatively influenced physician opinion of emerging therapies," said Decision Resources Analyst Bethany Kiernan, Ph.D. "As a result of overarching concerns over safety and efficacy, we forecast that no emerging therapies will obtain blockbuster status through 2020."

About Pharmacor from Decision Resources
Pharmacor is a unique family of studies that assesses a host of market-impacting factors and analyzes the commercial outlook for drugs in research and development.

About Decision Resources
Decision Resources ( is a world leader in market research publications, advisory services, and consulting designed to help clients shape strategy, allocate resources, and master their chosen markets.

All company, brand, or product names contained in this document may be trademarks or registered trademarks of their respective holders.

For more information, contact:
Elizabeth Marshall
Decision Resources, Inc.

SOURCE Decision Resources, Inc.

Tuesday, March 27, 2007

The Immune Response Corporation injects first patient in Trial of NeuroVaxä for treatment of Multiple Sclerosis

Investigational Immune Based Therapy Could Provide New Hope to the 2.5 Million Patients Who Suffer from MS

CARLSBAD, CA - March 7, 2007 - The Immune Response Corporation (OTCBB: IMRP) today announced the injection of the first patient in a large multi-center Phase II study of NeuroVax™, an investigational T-Cell Receptor peptide vaccine for the treatment of relapsing-remitting multiple sclerosis (MS). NeuroVax™ may represent a significant advance in the treatment of MS, which affects more than 2.5 million people worldwide, including more than 400,000 in the United States.

“We are pleased to initiate this important trial,” said Dr. Joseph O’Neill, President and CEO of The Immune Response Corporation. “This study will allow us to examine the potential of NeuroVax™ to help patients with multiple sclerosis, to better understand our platform technology in autoimmune diseases, and position our MS program for a strong commercial partnership.”

In MS, a specific subset of a patient’s own white blood cells, pathogenic T-cells, attack myelin, a fatty tissue in the central nervous system, which surrounds and protects nerve fibers. This pathologic process creates multiple areas of inflammation that ultimately lead to scarring (sclerosis) and that interfere with normal transmission of nerve impulses. This nerve damage, in turn, leads to a variety of chronic and often debilitating neurological symptoms, ranging from serious movement and balance problems to vision impairment.

NeuroVax™, which is based on the Company’s patented T-cell receptor (TCR) peptide vaccine technology, has shown potential clinical value in the treatment of relapsing forms of MS. NeuroVax™ has been shown to stimulate strong, disease-specific cell-mediated immunity in nearly all treated patients. NeuroVax™ appears to work by enhancing levels of FOXP3+ regulatory T-cells (Treg cells) which may help regulate expression of pathogenic T-cells in MS patients. Previous clinical trials conducted by the Company and other independent researchers have associated diminished levels of FOXP3+ Treg cell responses with the pathogenesis and progression of MS and other autoimmune diseases such as rheumatoid arthritis (RA), psoriasis and Crohn’s disease. In addition to MS, the Company has proprietary technology and prior clinical experience for evaluation of TCR peptide-based immune-based therapies for RA and psoriasis.

“By restoring FOXP3+ Regulatory T-cell functions to levels seen in healthy individuals, NeuroVax™ may offer a new and highly targeted mechanism to control pathogenic T-cell activity and limit or prevent nerve tissue damage in MS patients,” said Dr. O’Neill. “Additionally, NeuroVax™’s once-a-month dosing, attractive side effect profile and ease of manufacture could benefit the millions of MS patients in need of effective and more tolerable treatment options.”

The goal of The Immune Response Corporation’s research program is to develop safe effective and affordable therapies for patients suffering from devastating diseases. The Company’s investigational vaccines for MS and other autoimmune diseases, as well as for treatment of HIV, are highly targeted, potentially less toxic medicines that seek to harness the body’s own defenses to control and possibly prevent disease. This approach may prove valuable in the discovery of novel immune-based therapies for a host of autoimmune and infectious diseases.

About the Study

This trial is a multi-center, randomized, double-blind, placebo-controlled 48-week study to assess the safety and efficacy of NeuroVax™. Two hundred subjects with relapsing-remitting MS, with an Expanded Disability Status Scale (EDSS) score of ≤ 5.5 and meeting all inclusion/exclusion criteria, will be enrolled in the study in several Central and Eastern European countries. The first trial patient was injected at a study site in Bulgaria and regulatory approval to begin enrolling has been obtained in Slovakia. Enrollment will continue in other countries as pending regulatory approvals to initiate the trial are approved.

The primary clinical endpoint of the study is to compare the cumulative number of new gadolinium enhancing lesions, a key marker of MS disease activity, using MRI scans at 24, 32, 40, and 48 weeks. Secondary objectives include additional MRI measurements, analysis of clinical relapses, measures of neurologic disability, immunologic evaluations, and safety.

Study participants will be randomized equally to receive NeuroVax ™ (100 micrograms/mL of each of three selected TCR Peptides), emulsified in Incomplete Freund’s Adjuvant (IFA) or placebo (IFA) intramuscularly in the deltoid muscle every four weeks. Evaluation will occur every eight weeks by brain MRI scan and patients will also undergo evaluation by neurology examinations at 12, 24, 36, and 48 weeks. Safety will be monitored by routine physical exams that will be performed at 24 and 48 weeks, and lab tests of hematology, chemistry panel and urinalysis will be performed at weeks 4, 12, 24, 36, and 4.

About The Immune Response Corporation

The Immune Response Corporation (OTCBB: IMRP, formerly IMNR) is an immuno-pharmaceutical company focused on developing products to treat autoimmune and infectious diseases. The Company’s lead immune-based therapeutic product candidates are NeuroVax™ for the treatment of MS and REMUNE® and IR103 for the treatment of HIV infection. These therapies are in Phase II clinical development and are designed to stimulate disease pathogen-specific immune responses aimed at slowing or halting the rate of disease progression.

NeuroVax™, REMUNE® and IR103 are in clinical development by The Immune Response Corporation and are not approved by any regulatory agencies in any country at this time. Please visit The Immune Response Corporation at for additional information.

This news release contains forward-looking statements. Forward-looking statements are often signaled by forms of words such as should, could, will, might, plan, projection, forecast, expect, guidance, potential and developing. Actual results could vary materially from those expected due to a variety of risk factors, including whether the Company will continue as a going concern and successfully raise proceeds from financing activities sufficient to fund operations and additional clinical trials of NeuroVax™ or IR103, the uncertainty of successful completion of any such clinical trials, the fact that the Company has not succeeded in commercializing any drug, the risk that NeuroVax™ or IR103 might not prove to be effective as either a therapeutic or preventive vaccine, whether future trials will be conducted and whether the results of such trials will coincide with the results of NeuroVax™ or IR103 in preclinical trials and/or earlier clinical trials. A more extensive set of risks is set forth in The Immune Response Corporation's SEC filings including, but not limited to, its Annual Report on Form 10-K for the year ended December 31, 2005, and its subsequent Quarterly Reports filed on Form 10-Q. The Company undertakes no obligation to update the results of these forward-looking statements to reflect events or circumstances after today or to reflect the occurrence of unanticipated events.

REMUNE® is a registered trademark of The Immune Response Corporation. NeuroVax™ is a trademark of The Immune Response Corporation.

MediciNova Announces Positive Clinical Results From MN-166 Phase II Multiple Sclerosis Trial

Conference Call to Discuss Results On Thursday, March 29, 2007, At 2:00 p.m. Pacific Time

SAN DIEGO, Mar 27, 2007 (PrimeNewswire via COMTEX News Network) -- MediciNova, Inc., a biopharmaceutical company that is publicly traded on the Nasdaq Global Market (Nasdaq:MNOV) and the Hercules Market of the Osaka Securities Exchange (Code Number:4875), today announced positive clinical findings from the 12-month core period of a Phase II clinical trial of MN-166 that measures both surrogate (radiological) and clinical outcomes over two years of treatment in 297 patients with relapsing multiple sclerosis (MS).

The randomized, double-blind, placebo-controlled trial showed a significant increase in the proportion of patients who remained relapse-free over the first 12 months of treatment with 60 mg per day of MN-166 compared to placebo (p=0.03). The time to first relapse was also significantly increased in patients treated with 60 mg of MN-166 per day compared to placebo (p=0.04). Positive trends were also observed in the annualized relapse rate (p=0.08) and number of relapses (p=0.10) among patients who completed the full first 12 months of treatment with 60 mg of MN-166 per day compared to those patients completing the first 12 months of treatment on placebo.

A significant reduction in brain volume loss (p=0.04), as measured by cranial magnetic resonance imaging (MRI) scans, was observed in patients treated with 60 mg per day of MN-166 compared to placebo. Loss of brain volume on MRI has been shown to correlate with clinical progression and disability in MS patients. Positive trends were also observed in several other radiological outcome measures, including the volume of gadolinium-enhancing (T1) lesions (p=0.09) in patients treated with 60 mg of MN-166 per day compared with placebo. However, no reduction in the cumulative number of active (gadolinium-enhancing (T1) and non-enhancing new/enlarging (T2)) lesions on cranial MRI scans over 12 months of treatment was observed in patients treated with MN-166 compared to placebo, which was the protocol-defined primary endpoint of the study. No clinical or radiological benefit was observed in patients treated with 30 mg per day of MN-166. MN-166 was well tolerated at all doses in this trial. Eighty-nine percent of patients completed the first 12 months of the trial with only mild gastrointestinal side effects observed with MN-166 compared to placebo (3-6% vs. 1-3%, respectively).

The independent Data Safety Monitoring Board (DSMB) has recommended that the trial continue beyond the first year of treatment without modification and was supportive of further clinical evaluation of MN-166 in MS patients.

"We are pleased with the benefit of MN-166 observed in MS patients in this trial; they confirm the results of previous pilot trials of MN-166 in MS patients conducted by Japanese academic investigators," said Yuichi Iwaki, M.D., Ph.D., Executive Chairman and CEO of MediciNova, Inc. "The divergence of clinical benefit and radiological findings suggest that MN-166 may be acting by a different mode of action than current treatments. We will carefully analyze the clinical data with our independent advisors to determine next steps in the development program and to advance this compound into Phase III clinical testing."

In July 2005, MediciNova initiated a randomized, double-blind, placebo-controlled multi-center Phase II clinical trial of MN-166 in MS patients in five Eastern European countries. A total of 297 patients with at least one gadolinium-enhancing lesion on a screening visit MRI scan were randomized to receive placebo or one of two doses of MN-166 (30 or 60 mg per day) in this trial. Safety and efficacy assessments were performed at months 1, 2, 4, 6, 8, 10 and 12 of the trial. Efficacy assessments were based on the evaluation of the cumulative number of active (gadolinium-enhancing (T1) and non-enhancing new/enlarging (T2)) cranial MRI lesions (the primary endpoint of the trial) and other MRI-related, exacerbation and disability-related endpoints (relapse rate and Expanded Disability Status Scale (EDSS) score) after 12 months of treatment. Eligible patients who elected to continue their participation in the trial after 12 months of treatment will continue to receive treatment and will be assessed at months 13, 14, 16, 18, 20, 22 and 24 of the trial; patients who received placebo during the first 12 months of the trial were randomized to receive either 30 or 60 mg of MN-166 per day (double-blind maintained) during the second 12 months of the trial.

About Multiple Sclerosis and MN-166

Multiple sclerosis (MS) is an inflammatory demyelinating disease of the central nervous system (CNS), affecting approximately 250,000 - 350,000 people in the U.S. The most obvious effect of MS is the progressive loss of muscle control, but multiple brain and CNS functions are also affected. There is no cure for the disease. Relapsing-remitting MS (RRMS), which is the most common type of the disease, affects approximately 65% of MS patients according to a Cognos study published by Decision Resources, Inc. Most patients with RRMS eventually progress to the secondary progressive (SPMS) form of the disease.

MN-166 is a novel, orally administered compound being evaluated for the treatment of MS. MN-166 inhibits leukotriene activity, phosphodiesterases and nitric oxide synthase, all inflammatory mechanisms known to be involved in MS. MN-166 may also suppress the production of pro-inflammatory cytokines (IL-1beta, TNF-alpha) and may enhance the production of the anti-inflammatory cytokines (IL-4, IL-10). In two pilot clinical trials sponsored by academic investigators in Japan, MN-166 was found to have certain beneficial effects with respect to the treatment of MS.

MediciNova acquired an exclusive, worldwide (excluding Japan, China, Taiwan and South Korea), sublicensable license to MN-166 for the treatment of MS, excluding ophthalmic solution formulations, from Kyorin Pharmaceutical Co. Ltd. For the past 17 years, MN-166 has been marketed in Japan and South Korea as Ketas(r) for the treatment of asthma and cerebrovascular disorders. Data from the existing clinical trial and post-marketing surveillance databases, which includes treatment of an estimated 3.2 million patients with these disorders, indicate that Ketas(r) is well tolerated.

Conference Call

Management will discuss the results in a conference call on March 29, 2007 at 2:00 p.m. Pacific Time. The dial-in numbers for the conference call are as follows: 800-479-9001 (Domestic); 719-457-2618 (International).

About MediciNova

MediciNova, Inc. is a publicly-traded biopharmaceutical company that acquires well characterized small-molecule drugs through strategic alliances with Japanese and other international pharmaceutical companies and accelerates their development in a diversified portfolio of therapeutic product candidates targeting significant disease markets. MediciNova's pipeline, which includes six compounds in clinical testing, targets a variety of prevalent medical conditions, including asthma, multiple sclerosis, status asthmaticus, interstitial cystitis, cancer, Generalized Anxiety Disorder, insomnia, preterm labor, urinary incontinence and thrombotic disorders. For more information on MediciNova, Inc., please visit

The MediciNova, Inc. logo is available at

Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding MediciNova's clinical trials supporting efficacy of a product candidate and the potential novelty of such product candidate as a treatment for disease, plans and objectives for present and future clinical trials, and plans and objectives for product development. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements, include, but are not limited to, the risks and uncertainties inherent in clinical trials and product development and commercialization, including the results of clinical trials, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, and the timing, cost and design of future clinical trials and research activities, and the other risks and uncertainties described in MediciNova's filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2006 and its periodic reports on Forms 10-Q and 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements.

This news release was distributed by PrimeNewswire,

SOURCE: MediciNova, Inc.

MediciNova, Inc.
Kenneth W. Locke, Ph.D., Chief Business Officer
Bonnie Feldman, D.D.S., M.B.A., Vice President of
Investor Relations
(C) Copyright 2007 PrimeNewswire, Inc. All rights reserved.

Monday, March 26, 2007

Novartis to launch its own branded version of a leading multiple sclerosis therapy through agreement with Bayer Schering Pharma

A Novartis-branded version of interferon beta-1b to be launched in first half 2009

Move strengthens Novartis multiple sclerosis (MS) portfolio ahead of on-track submission in 2009 of once-daily oral therapy FTY720, currently in Phase III trials.

Novartis will transfer manufacturing responsibility for Bayer Schering Pharma's interferon beta-1b (marketed as Betaseron®[1]) to Bayer Schering Pharma.

Bayer Schering Pharma to pay approximately USD 200 million for transfer of production equipment, inventory and leasing of buildings at California site.

Novartis to continue receiving royalties from global sales of Bayer Schering Pharma's Betaseron until October 2008.

Basel, March 26, 2007 - Novartis has signed an agreement with Bayer Schering Pharma AG that will provide Novartis the opportunity to introduce in the first half of 2009 its own branded version of interferon beta-1b for patients with the debilitating neurological disease multiple sclerosis (MS).

The planned launch of a Novartis-branded version, which requires approval from regulatory authorities, will give Novartis an increasing presence in helping patients with MS ahead of the anticipated submission in 2009 of its oral once-daily therapy FTY720 (fingolimod), which is currently in Phase III trials.

Bayer Schering Pharma will support Novartis in the regulatory filing process of a Novartis-branded version of interferon beta-1b. They will also assume manufacturing responsibility for its interferon beta 1b from Novartis and supply Novartis with this product for its own branded version in return for a double-digit royalty payment. Novartis has the right to further develop new formulations and presentations of its branded version of this medicine.

"This agreement gives us an opportunity to strengthen our Neuroscience portfolio and build our presence in multiple sclerosis while preparing for the submission of FTY720 as planned for 2009," said Thomas Ebeling, CEO of Novartis Pharma AG. "As a truly new treatment approach with once-daily oral dosing, we believe FTY720 can offer significant therapeutic benefits to MS patients."

Under the terms of the agreement, Novartis will transfer manufacturing responsibility for interferon beta-1b to Bayer Schering Pharma, which will purchase the related equipment and lease certain buildings at a Novartis site in Emeryville, California, for a one-time cash payment of approximately USD 110 million. Bayer Schering Pharma will also purchase related interferon beta-1b product inventory for an estimated USD 90 million cash, which is subject to adjustment at closing.

Bayer Schering Pharma will continue to pay Novartis royalties on worldwide net sales of Betaseron® until October 2008 when the original regulatory filing, development and supply agreement expires.

Novartis plans to maintain in Emeryville the operations of its Vaccines and Diagnostics division, including the headquarters for its diagnostics business, as well as pharmaceutical research conducted by the Novartis Institutes for Biomedical Research (NIBR).

This agreement with Bayer Schering Pharma is subject to regulatory approvals, including antitrust review, and is expected to be completed by the third quarter of 2007.

Multiple sclerosis is estimated to affect more than 2.5 million patients worldwide and is one of the leading causes of neurological disability in young adults. This disease typically presents in relapsing forms involving acute self-limiting attacks of neurological dysfunction (or relapses), followed by complete or partial restoration of function.[2]

Betaseron is marketed by Bayer Schering Pharma AG, which Bayer AG acquired in 2006. In 1993 Bayer Schering Pharma signed an agreement covering the regulatory filing, development and supply of Betaseron with Chiron, which Novartis acquired in 2006. Novartis assumed Chiron's rights to this product, and since then has continued to produce Betaseron.

This release contains certain forward-looking statements relating to the business of Novartis, which can be identified by the use of forward-looking terminology such as "to launch", "to be launched", "on track", "will", "to pay", "to continue", "to introduce", "planned", "anticipated", "to further develop", "believe", "plans", "expected", or similar expressions, or by express or implied discussions regarding the potential regulatory approval and completion of the announced agreement with Bayer Schering, or regarding potential future regulatory submissions or approvals or regarding potential future revenues from interferon beta-1b, new formulations or presentations of interferon beta-1b, or FTY720. Such forward-looking statements reflect the current views of Novartis regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with interferon beta-1b or FTY720 to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that the announced deal will receive the necessary regulatory approvals, or if approved, will be completed, or that interferon beta-1b, new formulations or presentations of interferon beta-1b, or FTY720 will be submitted for approval or will be approved for sale for any indications or labeling in any market. Nor can there be any guarantee that interferon beta-1b, new formulations or presentations of interferon beta-1b, or FTY720 will achieve any sales or any particular level of sales. In particular, management's expectations could be affected by, among other things, unexpected clinical trial results, including additional analysis of existing clinical data or new clinical data; unexpected regulatory actions or delays or government regulation generally; competition in general; government, industry and general public pricing pressures; Novartis' ability to obtain or maintain patent or other proprietary intellectual property protection, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis
Novartis AG (NYSE: NVS) is a world leader in offering medicines to protect health, cure disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. Novartis is the only company with leadership positions in these areas. In 2006, the Group's businesses achieved net sales of
USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 101,000 associates and operate in over 140 countries around the world. For more information, please visit

[1] Marketed as Betaferon® in Europe
[2] Multiple Sclerosis International Federation

# # #

Novartis Media Relations

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Friday, March 23, 2007

Scientists on brink of breakthrough in MRI scanning

GRAEME SMITH March 22 2007

A quarter of a century ago an elderly Fraserburgh man with terminal cancer became the first in the world to undergo an MRI body scan in a development which has saved thousands of lives.

Now, just yards from that pioneering scanner, Aberdeen scientists and clinicians are on the brink of another global MRI breakthrough which could save thousands more.

A prototype of an MRI scanner has been developed which will help earlier diagnosis of cancer, Alzheimer's, and Parkinson's disease and multiple sclerosis. Now funding has been approved to build one which can be used in clinical trials.

Since the first scan to highlight the tumours on the patient's liver, MRI has become one of modern medicine's most important diagnostic tools all over the world.

The developments by Professor John Mallard and his team in 1980 earned Aberdeen University tens of millions of pounds and it is hoped the latest breakthrough could provide similar financial rewards.

Professor David Lurie and a team of university and industrial collaborators - physicists, engineers, chemists, biologists and medical scientists - have been awarded £2.5m from the Engineering and Physical Sciences Research Council to build the working scanner over the next four years.

Professor Lurie said standard MRI allows images from inside a patient's body to be taken using a single magnetic field which is set when the machine is installed. The new technique, which has proved successful in principle and in tissue trials, should allow images of the patient to be taken at several different magnetic fields.

"It's a bit like having at our disposal a hundred or more MRI scanners, each one operating at a different magnetic field - but all in the one scanner," said Professor Lurie.

"It will be of use in research and diagnosis into conditions such as Parkinson's disease, which involves proteins in the brain, Alzheimer's disease, which also involves proteins in the brain, multiple sclerosis and, potentially, cancer."

He said there was also potential for non-clinical uses, like measuring protein changes during food processing.

© All rights reserved. Reproduction in whole or in part without permission is prohibited.

Thursday, March 22, 2007

Argos Therapeutics Awarded U.S. Patent for CD83 Protein for Use in Immunological Disorders

Mar 22 2007, 8:05 AM EST

Business Wire

Argos Therapeutics today announced the issuance of United States Patent 7,169,898, which covers soluble forms of the protein CD83. Soluble forms of CD83 can be used to treat a variety of disease indications resulting from unabated cellular immune responses, including autoimmune disorders such as multiple sclerosis, as well as for transplantation rejection.

"CD83 has shown promising activity as an efficient immunosuppressant and Argos is leveraging its expertise in immune system function and dendritic cells in the development of this compound," said John Bonfiglio, Ph.D., President and CEO of Argos. "This patent further extends our CD83-related intellectual property portfolio and protects our continued development of this exciting, novel asset."

CD83 is a glycoprotein expressed on the cell surface of mature dendritic cells (DCs), the most potent stimulators of immune responses. The strong upregulation of this protein during DC maturation suggests that it plays an important functional role in the induction of immune responses. Experimental data demonstrate that soluble CD83 can potently down-regulate immune responses, indicating that it can be developed to treat transplantation rejection and variety of autoimmune disorders. Importantly, data from animal models demonstrate that soluble CD83 exerts its effects without a requirement for chronic administration and does not leave the subject globally immunosuppressed. In April 2006, Argos obtained exclusive therapeutic use rights for CD83 from Beckman Coulter.

"Argos plans to build on this positive data and has planned additional studies in transplantation and autoimmune models, the results of which will help drive our clinical development strategy for this candidate," said Dr. Charles Nicolette, Chief Scientific Officer and Vice President of Research and Development of Argos.

About Argos Therapeutics, Inc.

Argos Therapeutics is developing breakthrough immunotherapies that target the unique features of a patient's disease. This new generation of personalized cancer and infectious disease therapeutics trains the immune system to recognize and attack the disease. Argos' scientific leadership in RNA-loaded dendritic cells and advanced manufacturing processes provide a platform to tackle virtually all forms of cancers and infectious diseases.

Argos is a private biotechnology company headquartered in Research Triangle Park, NC. The Company has clinical trial programs in cancer and human immunodeficiency virus (HIV) and has an ongoing co-development and commercialization alliance with the Pharmaceutical Division of Kirin Brewery Company, Limited.

Alternative Medicine: Traditional Chinese medicine for multiple sclerosis

Multiple sclerosis is an inflammatory, autoimmune disease of the central nervous system, generally striking during early adult years. Its most frequent symptoms include numbness, impaired vision, loss of balance, weakness, bladder dysfunction and psychological changes. While there is no cure for the disease, acupuncturists can offer significant help managing symptoms and side effects. In a 2002 survey of multiple sclerosis patients at the Rocky Mountain MS Center in Boulder, Colo., more than 50 percent of patients receiving acupuncture noted significant improvement in symptoms of pain, anxiety, depression, fatigue, muscle stiffness and numbness. Additionally, many noted improvement in walking problems, weakness and balance, while others saw positive changes in urinary and bowel problems.

Traditional Chinese medicine, a 5,000-year-old medical tradition, has no definitive diagnosis of multiple sclerosis. Many classical texts refer to a syndrome known as a Wei (or atrophy) syndrome. There are multiple presentations of a Wei syndrome, and each can result from different factors. These may include any combination of improper diet, emotional stress, shock and possibly heredity.

Visits to a licensed acupuncturist for multiple sclerosis may include traditional acupuncture, electroacupuncture (gentle electrical stimulation of meridian points) as well as dietary advice, Qi Gong and Chinese herbs. Treatment will be designed to help resolve symptoms as well as address underlying conditions that may cause symptoms. Traditional Chinese medicine is in no way a replacement for conventional therapies. The medical advice of a board-certified neurologist should be followed during any course of treatment.

Michael Spano, Bastyr University Center for Natural Health

Bastyr is a non-profit, private university offering graduate and undergraduate degrees, with a multidisciplinary curriculum in science-based natural medicine. The university's Seattle teaching clinic, Bastyr Center for Natural Health, is the Northwest's largest natural medicine clinic. Go to or

Inhibiting Blood to Save the Brain

Researchers at the UCSD School of Medicine have identified a fibrin-derived peptide that inhibits this specific inflammation process in mouse models of MS, reducing MS symptoms.

Newswise — A fibrous protein called fibrinogen, found in circulating blood and important in blood clotting, can promote multiple sclerosis (MS) when it leaks from the blood into the brain, triggering inflammation that leads to MS-related nerve damage. Researchers at the University of California, San Diego (UCSD) School of Medicine have identified a fibrin-derived peptide that inhibits this specific inflammation process in mouse models of MS, reducing MS symptoms.

“Current strategies to develop therapies to fight MS primarily target T cells,” said Katerina Akassoglou, Ph.D., assistant professor in UCSD’s Department of Pharmacology, whose study was published in the March 19 issue of Journal of Experimental Medicine. “Blood proteins have been neglected as a therapeutic target, but this research shows that a blood clotting factor is an important player in MS.”

MS is an inflammatory disease that affects the central nervous system, causing symptoms such as loss of balance and muscle coordination, and changes in cognitive function. The disease is marked by loss of myelin, a material that coats nerve fibers. Past studies showed that the destruction of the myelin sheath is associated with the accumulation of fibrinogen deposits in the brain of human MS patients. In this study, Akassoglou and colleagues showed that fibrinogen is not merely associated with the damage in MS, but an active participant. Fibrinogen activates macrophage cells in the brain called microglia, causing inflammation which damages myelin.

The scientists sought to design a therapeutic strategy that would block the damaging effects of fibrinogen without affecting its beneficial blood coagulation. Studying a mouse model, the researchers identified a specific receptor called Mac-1 that is expressed by microglial cells and binds to fibrinogen. Mice expressing a mutant form of fibrinogen that failed to bind Mac-1 had fewer inflammatory lesions and less severe MS symptoms. Blocking the interaction between Mac-1 and fibrinogen after the first episode of paralysis using the fibrin peptide prevented subsequent relapses. It also prevented further microglia activation and damage to myelin in the diseased mice, allowing them to survive with improved motor function.

“Importantly, this approach blocks fibrin’s interaction with microglia, but not with platelets, so clotting wouldn’t be impacted,” said Akassoglou, adding that this potential MS therapy might also have applications to other blood-brain barrier diseases where blood leakage and microglia activation is present such as spinal cord injury, Alzheimer’s disease or stroke.

Additional contributors to the paper include Ryan A. Adams, Shoana L. Sikorski and Tal Nuriel of UCSD’s Department of Pharmacology; Jan Bauer and Hans Lassmann, Center for Brain Research, Medical University of Vienna; and Matthew J. Flick and Jay L. Degen, Children’s Hospital Research Foundation and University of Cincinnati College of Medicine.

Funding for the study was provided in part by the National Institute for Neurological Disorders and Stroke, part of the National Institutes of Health, and by the National Multiple Sclerosis Society.

Lipitor (atorvastatin) As A Treatment For Spinal Cord Injuries Following Trauma

In a multidisciplinary investigation led by Inderjit Singh, Ph.D, a breakthrough has been made in relation to the treatment of spinal cord injuries (SCI). Set for publication in the April issue of the Journal of Neurochemistry (101, 182-200), the study investigates the efficacy of atorvastatin (AT), commonly known as Lipitor, as a treatment for spinal cord injuries following trauma. The report demonstrates, for the first time, that by using AT in treating spinal cord injuries after they have occurred, animal models with hind-limb paralysis showed significant functional recovery and less secondary tissue damage. Importantly, scientists discovered that AT also protects the cells responsible for producing myelin in the spinal cord, a substance which maintains normal function by insulating nerve fibers that carry signals through the spinal cord. Therefore, this discovery of post-injury AT treatment may be extremely valuable in preserving neurological function and walking following spinal cord injuries.

Singh is a Pediatrics distinguished university professor, Division of Developmental Neurogenetics director and Darby Children's Research Institute scientific director.

Spinal cord injury is a major cause of disability, and the current therapy with high dose steroids offers little benefit. Statins, including AT, belong to a class of drugs that are known to affect numerous cellular processes. Experimental investigations and clinical trials in patients have established the neuroprotective efficacy of statin treatment in multiple sclerosis, Alzheimer's disease, stroke and spinal cord injuries.

"These exciting findings suggest that AT shelters myelin producing cells and neurons during the inflammatory storm produced by trauma, and that when the storm has passed that such cells resume myelin production," said DCRI executive director, neurologist and neuroscientist Bernard Maria, M.D. "It opens up a new paradigm for treatment of spinal cord injury by preserving the integrity of progenitor cells that would otherwise have died off."

It is now accepted that the site, nature, and duration of secondary inflammations occurring immediately after a spinal cord injury determine the extent of functional loss or paralysis, and early reduction of these events is shown to minimize functional loss and enhance recovery. As a result, anti-inflammatory and neuroprotective agents, including statins, are the favored first line of defense as therapeutic agents in spinal cord injuries.

Singh said, "I am blessed to be leading a team of talented investigators who do pioneering work to delineate the mysteries of nature to develop novel treatments for neurological disorders. I'm especially proud of the pioneering work performed in the Darby Children's Research Institute to protect the brain stem cells for regeneration in various disease processes, such as multiple sclerosis and spinal cord injury. Presently, these drugs are being evaluated for therapy in inflammatory neurological disorders."

Neurodegeneration post-injury is evident in the form of white matter destruction that includes loss of tissue viability, degeneration of severed axons and myelin destruction. AT treatment post-SCI reduced these processes. Furthermore, AT treatment prevented apoptotic neuronal loss. This is of critical value in spinal cord injuries, as neuroprotective treatments after injury have the potential to lead to improved functional recovery and only a few residual axons (5-10%) are needed to achieve significant functional recovery.

While considering regenerative approaches, depending on the nature and extent of injury, it is likely that AT by itself or maybe in combination with other therapeutic approaches, such as stem cell transplantation, could prove beneficial and augment functional recovery. As immune suppression has been found beneficial for survival of transplanted cells, it is likely that anti-inflammatory actions of post-injury AT treatment could compliment cell grafting by creating a growth supportive environment to augment survival and differentiation of these cells to enhance the reparative process.

Emphasizing the therapeutic potential of post-injury AT treatment in spinal cord injuries, the investigation also strengthens the idea of long-term benefits that include reduction of secondary pathology through suppression of inflammation, Wallerian degeneration, gliosis, and most importantly - neuronal apoptosis.

This study is only the beginning of an endeavor to uncover the extensive potential of AT in treating spinal cord injuries as the various facets of this drug need to be carefully examined to more precisely determine the clinical effects of statins, the differential potency of statins, and to evaluate whether combination therapy might be more effective than monotherapy. However, due to the long-established human safety of statins, this report is likely to have positive clinical implications for spinal cord treatment.

About MUSC

Founded in 1824 in Charleston, The Medical University of South Carolina is the oldest medical school in the south. Today, MUSC continues the tradition of excellence in education, research, and patient care. MUSC is home to over 3,000 students and residents, as well as nearly 10,000 employees, including 1,300 faculty members. As the largest non-federal employer in Charleston, the University and its affiliates have collective budgets in excess of $1.3 billion per year. MUSC operates a 600 bed medical center, which includes a nationally recognized Children's Hospital and a leading Institute of Psychiatry. For more information on academic information or clinical services visit or

Medistem Laboratories Announces Tolerostem(TM) Platform as Second Pipeline Product for Potential U.S. Commercialization

Product Aims to Reprogram Immune System, Providing New Therapy for Autoimmune Diseases and Transplant Rejection

SCOTTSDALE, AZ -- (MARKET WIRE) -- March 21, 2007 -- Medistem Laboratories, Inc. (OTCBB: MDSM) (FRANKFURT: S2U) announced today its second pipeline candidate, Tolerostem™, a cellular therapy platform aimed at controlling harmful immunological responses through the use of adult stem cells undergoing a proprietary modification.

If approved for human use, the Tolerostem™ platform could make a significant contribution in the treatment of multiple autoimmune diseases ranging from rheumatoid arthritis, to multiple sclerosis, to Type I diabetes. Additionally, Tolerostem™ offers the possibility of "tricking" the immune system of transplant recipients, so as to prevent the need for chronic immune suppression, which has been shown to cause significant adverse effects.

The Tolerostem™ platform is based on the fundamental concept that the regulatory T cell, a type of anti-inflammatory cell in the immune system is activated by stem cells of specific lineages. Regulatory T cells subsequently home to areas of pathological inflammation and "teach" the inflammatory cells to stop attacking the host's tissue. If successful, Tolerostem™ opens the door to a therapeutic approach whereby the body regulates itself without the need for other types of medical intervention.

"Proof-of-principle that stem cells are capable of controlling harmful immune responses is being demonstrated by companies such as Osiris Therapeutics who are in Phase III clinical trials" said Neil Riordan Ph.D, President and CEO of Medistem. "Our Tolerostem™ platform leverages these prior successes with the aim of introducing a simple, patient-specific solution that could be widely commercialized."

Thomas Ichim, Medistem's Chief of Scientific Development, added, "While circumstantial evidence of stem cell mediated immune modulation has been suspected for some time, we believe based on clinical data from our licensees, that we have identified a completely novel use for manipulated stem cells. This application is covered directly and indirectly in several Medistem patent applications."

Currently Medistem is in discussions with immunology laboratories for performing preclinical safety and efficacy experiments to hopefully enable Investigational New Drug (IND) filing with the FDA in the last quarter of 2007. If accepted by the FDA, the company will then work towards initiating U.S. clinical trials.

About Medistem Laboratories, Inc.

Medistem Laboratories ( is an innovative biotechnology company committed to the creation and commercialization of advanced medical therapies based on non-controversial adult stem cells. Medistem's corporate mission is to transform these stem cells into valuable medical treatments. The Company's business strategy calls for the licensing of a series of clinics and laboratories around the world to deliver unprecedented, next-generation cell therapies to help millions of patients while seeking to commercialize products in the U.S. market. Clinic treatments use proprietary technology and cells sourced from umbilical cords, fat, bone marrow, and muscle for the treatment of cerebral palsy, stroke, cardiovascular disease and orthopedic diseases. Medistem believes it may hold a substantial competitive edge in the worldwide emerging market for stem cell-sourced medical solutions, positioning it to become a leading global provider of stem cell treatments on a fee-for-service basis, while accumulating intellectual property based on clinical and laboratory findings.

Cautionary Statement

This document does not constitute an offer to sell or a solicitation of an offer to buy any of our securities. This document contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements may include projections of matters that affect revenue, the ability to develop or license certain technologies; operating expenses or net earnings; projections of capital expenditures; projections of growth; hiring plans; plans for future operations; financing needs or plans; plans relating to the company's products and services; and assumptions relating to the foregoing.

Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking information.

Some of the important factors that could cause the company's actual results to differ materially from those projected in forward-looking statements made by the company include, but are not limited to, the following: technology development limitations, intense competition, risk of business interruption, management of rapid growth, need for additional financing, regulatory approvals and requirements, dependence on key personnel and research, management and other administrative costs.

These factors are discussed in greater detail in the company's quarterly and annual periodic reports, all as filed with the Securities and Exchange Commission.

Medistem Laboratories, Inc.
Chris McGuinn

SOURCE: Medistem Laboratories

Tuesday, March 20, 2007

NEOUCOM professor seeks cure to neurodegenerative disease

Priscilla Tasker

Issue date: 3/20/07 Section: News

Neurodegenerative diseases such as Alzheimer's disease, multiple sclerosis, Parkinson's disease and others affect more than 20 million people worldwide.

Researchers at Northeastern Ohio Universities College of Medicine and Pharmacy in Rootstown, have been conducting research to develop a drug that could stop the processes that cause such diseases. The focus of the research is a molecule called NGP1-01, which has the potential to treat several factors that result in the deterioration of neurons in the brain, said Dr. Neels Van der Schyf, founding chair of NEOUCOM and professor at Kent State.

"Each individual has 80 to 90,000 dopaminergic neurons," Van der Schyf said. "Now that sounds like a lot, but you reach your peak in your early 20s. After that they start to die down one by one."

Dopaminergic neurons control brain functions including voluntary movement and behaviors associated with stress, mood and addiction, according to the National Center for Biotechnology Information Web site. Loss of this type of neuron is characteristic of Parkinson's disease.

A person may lose up to 80 percent of those neurons and still operate normally, never knowing that something is happening. Symptoms of a neurodegenerative disease would begin to surface when the neurons are depleted to about 20 percent, Van der Schyf said.

The theory behind the drug research is that the neurodegeneration can be slowed down before reaching that 20 percent range.

"Arguably if we could catch an individual with 30 percent of the (neurons) still intact we could probably prevent the neurodegeneration and have them live out a normal life," Van der Schyf said.

NGP1-01 has the potential to treat certain causes of neurodegeneration because of its ability to cross the blood-brain barrier. This means that the molecule is able to access cells in the brain, which is a rare discovery, Van der Schyf said.

The molecule's mechanism as a calcium-channel blocker balances the calcium influx in the brain cells that leads to the deterioration of the neurons, he said. It also has the ability to weaken or lessen excitotoxicity in the brain. Excitotoxicity refers to an excessive release of the chemical that transports messages from cell to cell, according to the Harvard Center for Neurodegeneration and Repair.

"If we have a mechanism by where we could very effectively and accurately diagnose an individual's propensity to develop Parkinson's, I believe we that have the tools to prevent that," Van der Schyf said, "Here's the dilemma, you may argue that OK, it's great to give a drug to everybody because we already know that the drug's going to prevent (it), but you don't know what the drug's going to do elsewhere. It may cause heart problems, it may do all kinds of things, which is why we cannot do that ethically."

In 2004, Vioxx, an inflammatory medication produced by Merck Inc., was pulled from the market because a study had found a higher rate of heart attack and stroke in patients who were on the drug.

"It was never discovered when they went to market, so we need to be extremely careful when giving any kind of molecule to a group of people," Van der Schyf said.

The Food and Drug Administration has strict rules for developing and marketing new drugs, he said. On average it takes about 12 years of research and clinical trials before the FDA approves a drug, and additional post-marketing studies are required as well, according to the Alliance Pharmaceutical Corp. Web site.

NGP1-01 is still in the pre-clinical testing phase of drug development, and researchers are testing the affect of the molecule in mice.

About five of nearly 5,000 drugs enter clinical trials (human testing sequences), according to Alliance Pharmaceutical's Web site, but only one of the five drugs receives approval from the FDA.

NGP1-01 will probably never make it to market, Van der Schyf said, but the goal of the research is to open the doors to other discoveries in neuro-drug development.

Contact health trends and NEOUCOM reporter Priscilla Tasker at

Chromos Announces Corporate Developments

For Immediate Release: March 19, 2007

Burnaby, British Columbia, Canada, Chromos Molecular Systems Inc. (“Chromos”) (TSX:CHR) announced today corporate developments related to its lead product candidate, CHR-1103, its convertible bridge loan and its Board of Directors.

Proposed CHR-1103 Collaboration
Chromos announced a non-binding term sheet with a U.S.-based biotechnology company under which it will enter into a collaboration agreement to co-develop its lead product, CHR-1103. Under the proposed collaboration, the U.S. biotechnology company will pay to Chromos US$3,000,000 upon execution of definitive agreements as well as additional future milestone payments. The partner company will assume the funding for a significant majority of the development expenses for the CHR-1103 program. Based on this expense funding ratio, the parties will share proportionately revenues related to the commercialization of CHR-1103, including all clinical indications. No other financial terms were disclosed. The transaction is subject to completion of final due diligence and execution of definitive agreements, which is expected to take place in April 2007.

“The formation of this collaboration will provide Chromos with a co-development partner for CHR-1103 that is led by a seasoned leadership team with the financial resources to assist driving this product through clinical development,” said Alistair Duncan, President and CEO of Chromos. “This collaboration will also allow us to mitigate risk in the development of our first therapeutic product candidate and to maintain our focus on continuing to grow our cell line engineering business utilizing our proprietary ACE System.”

CHR-1103 is a humanized monoclonal antibody directed against VLA-2, an integrin involved in maintenance of inflammation. In preclinical studies, it has been demonstrated that anti-VLA2 therapy reduces clinical signs of inflammation in animal models of multiple sclerosis (MS), inflammatory bowel disease and arthritis. The initial focus CHR-1103 is the acute treatment of relapse in MS. It is anticipated that an Investigational New Drug (IND) application for CHR-1103 will be filed at the beginning of 2008.

Amendments to the Terms of the Convertible Bridge Loan

Chromos has increased the convertible bridge loan financing arrangement that was previously announced on October 20, 2006 by $150,000 to $2,150,000. The additional proceeds of the loan will be used to fund operations of Chromos as it seeks to complete the proposed CHR-1103 collaboration and to raise additional financing.

In addition, for the promissory notes issued under the bridge loan, effective anytime after March 29, 2007 the note holders may demand repayment of the notes together with any accrued interest on one days’ notice. This is a reduction in the notice period from the previous 10 days notice. In addition, if Chromos does not provide, on or before March 21, 2007, evidence to the satisfaction of the note holders that an equity financing is being arranged for a specified minimum size with a portion of the proceeds being used to repay the notes, then the notes will become immediately due and payable. The Company is actively pursuing an equity financing that is intended to provide the required evidence. The note holders, who are also significant common shareholders of the Chromos, have assured the Company of their endorsement for both a successful equity financing outcome and the proposed CHR-1103 collaboration. The conversion feature for the bridge loan has also been amended so that it is at the option of the note holders.

Chromos’ current funds on hand, anticipated revenues from existing contractual agreements and the $150,000 of additional funds available from the bridge loan financing are expected to be sufficient to fund its operations until approximately the end of April of 2007. This assumes that in the interim the note holders of the bridge loan have not otherwise demanded repayment, in accordance with their rights as noted above, in which case Chromos would have insufficient funds to satisfy repayment requirements. There can be no assurance that Chromos will be able to complete the proposed CHR-1103 collaboration transaction or that additional financing will be available at all or on acceptable terms to permit Chromos’ current operations to continue. If Chromos is unsuccessful in raising additional financing it may be required to scale back or terminate certain or all of its operations.

Director Resignation
Chromos also announced that Mr. David Barr has resigned from its Board of Directors. Mr. Barr is CFO and Investment Manager of PenderFund Capital Management Ltd. which manages funds that are holders of a portion of the convertible, secured promissory notes. Mr. Barr indicated that he tendered his resignation as a director to avoid any potential conflict of interest created by PenderFund’s ownership position of the convertible bridge loan referred to above.

This resignation brings the number of directors on the Board to four.

About Chromos
Chromos is a biopharmaceutical company with two drug development programs focused on inflammatory diseases and thrombotic disorders. The Company's lead product, CHR-1103, is a humanized monoclonal antibody being developed as an acute treatment for relapses associated with multiple sclerosis (MS). Chromos generates revenue from its proprietary ACE System technology to engineer production quality cell lines to manufacture biopharmaceutical products including monoclonal antibodies. For more information, please visit our website at

Risks and Uncertainties
Certain of the statements contained in this press release are forward-looking statements which involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Chromos (the “Company”), or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements.

To the extent possible, management implements strategies to reduce or mitigate the risks and uncertainties associated with the Company’s operations. Operating risks include (i) the continued availability of capital to finance the Company’s activities; (ii) the Company’s limited cash position, (iii) the ability to successfully obtain proof of the effectiveness of the Company’s technology (iv) the ability to complete and maintain corporate alliances, including the proposed CHR-1103 collaboration, relating to the development and commercialization of the Company’s technology; (v) the ability to obtain and enforce patent and other intellectual property protection for the Company’s technology; (vi) market acceptance of the Company’s technology; (vii) the competitive environment and impact of technological change; (viii) the Company’s ability to attract and retain employees to carry out its business plans; (ix) the timely development and commercialization of any technology or products that are contingent on the completion and maintenance of corporate alliances with third parties; (x) the demand for repayment of the outstanding notes by the note holders and (xi) regulatory approval of the conversion of the outstanding notes. Further details on Chromos’ operating risks can be found in the Company’s Quarterly and Annual Reports to Shareholders.

For Further Information:
Jeff Charpentier, CA
Vice President Finance and CFO

Monday, March 19, 2007

Acorda Therapeutics Presentation of Fampridine-SR Phase 3 Data Selected for Scientific Highlights Program at the American Academy of Neurology Meeting

HAWTHORNE, N.Y.--(BUSINESS WIRE)--March 19, 2007--Acorda Therapeutics (Nasdaq: ACOR) today announced that Andrew Goodman, M.D., Director of the Multiple Sclerosis Center at the University of Rochester, will present data from Acorda's MS-F203 Phase 3 clinical trial of Fampridine-SR in multiple sclerosis at the upcoming American Academy of Neurology (AAN) meeting. The platform presentation will take place on Wednesday May 2, 2007 at 4:15 pm Eastern Time (ET). This abstract was also selected to be part of the Scientific Highlights program, which spotlights the top five percent of the more than 1600 abstracts accepted for presentation at this meeting. The AAN meeting will take place at the Hynes Convention Center in Boston, MA.

Forward Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including Acorda Therapeutics' ability to successfully market and sell Zanaflex Capsules, the risk of unfavorable results from future studies of Fampridine-SR, delays in obtaining or failure to obtain FDA approval of Fampridine-SR, competition, the ability to obtain additional financing to support Acorda Therapeutics' operations, unfavorable results from its preclinical programs, and failure to protect its intellectual property or to defend against the intellectual property claims of others. These and other risks are described in greater detail in Acorda Therapeutics' filings with the Securities and Exchange Commission. Acorda Therapeutics may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. Acorda Therapeutics disclaims any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

About Acorda Therapeutics

Acorda Therapeutics is a biotechnology company developing therapies for SCI, MS and related nervous system disorders. The Company's marketed products include Zanaflex Capsules(TM) (tizanidine hydrochloride), a short-acting drug for the management of spasticity. For full prescribing information, please go to Acorda's lead clinical stage product, Fampridine-SR, recently completed a Phase 3 study in people with MS. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain.

CONTACT: Acorda Therapeutics
Erica Wishner, 914-347-4300 ext. 162

SOURCE: Acorda Therapeutics

Opexa Therapeutics to Be Featured in Live Interview

Mar 19 2007, 6:30 AM EST

Business Wire

Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company involved in the development and commercialization of cell therapies, announced that its chief executive officer, David McWilliams, will be featured in a live Market News First interview on Tuesday, March 20, 2007 at 9:30 am Central Time. The interview can be heard live on Market News First's website at

The interview will also be available in a podcast which can be downloaded from the Market News First website within 48 hours of the interview.

Mr. McWilliams will discuss the Company's ongoing clinical trials for its novel therapeutic, Tovaxin(TM), for multiple sclerosis as well as the innovative therapies the Company is developing to treat rheumatoid arthritis and diabetes.

About Opexa Therapeutics

Opexa Therapeutics develops and commercializes cell therapies to treat autoimmune diseases such as MS, rheumatoid arthritis, and diabetes. The Company is focused on autologous cellular therapy applications of its proprietary T-cell and stem cell therapies. The Company's lead product, Tovaxin(TM), a T-cell therapy for multiple sclerosis is in Phase IIb trials. The Company holds the exclusive worldwide license for adult multipotent stem cells derived from mononuclear cells of peripheral blood. The technology allows large quantities of monocyte derived stem cells to be produced efficiently for use in autologous therapy, thus circumventing the threat of rejection. The Company is in preclinical development for diabetes mellitus.


Market News First is an online, market news provider that brings investors current news on the market. Market News First is the only online, live radio web site that brings real market news to investors and features live interaction with companies from the Bulletin Board to NYSE.

Through daily, live interviews, we bring you up to date on all the established companies and inform the investors of the newest opportunities within the market. Market News First offers one-on-one interviews with the presidents and CFOs of companies to deliver answers to the questions that investors may ask and provides them insight into the companies' present condition and future plans.

Safe Harbor Statement

This press release contains "forward-looking statements," including statements about Opexa Therapeutics' growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. These forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to Opexa Therapeutics' ability to obtain additional funding, develop its stem cell technologies, achieve its operational objectives, and obtain patent protection for its discoveries, that may cause Opexa Therapeutics' actual results to be materially different from any future results expressed or implied by such forward-looking statements. Opexa Therapeutics undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

Thursday, March 15, 2007

A healthy high-risk pool

Point of View:
Adam Searing

RALEIGH - The General Assembly is finally working on a serious proposal to make health insurance more affordable. State Rep. Verla Insko's health insurance high-risk pool bill has already passed two House committees. The debate offered a preview of what's ahead for the state's first significant health reform in years.
Some people, because they have a serious health condition such as multiple sclerosis, are quoted $1,000 to $2,000 a month premiums when they try to buy insurance. A high-risk pool for health coverage -- like the high-risk insurance pool for automobile insurance -- puts people with serious health problems (or risks) into a pool where they pay still-high but more affordable premiums for decent coverage.

Even though people in the pool pay a higher premium than those without serious health problems, it still costs more to insure them than the premiums collected to cover medical costs, because people in the pool are so sick. So all insurance companies are assessed a fee based on the number of people they insure, to help cover the excess cost.

This is exactly how the high-risk pool for automobile insurance works -- we spread the costs for riskier drivers out over the entire insurance pool. With more expensive but still-affordable coverage available, more people buy auto insurance. This means there are fewer uninsured drivers and rates for everyone are lower, because even the riskiest drivers pay premiums and fund the insurance pool, instead of driving uninsured and making everyone else pay if they have an accident.

As a result, according to the Insurance Information Institute, North Carolina has one of the lowest rates of uninsured drivers, and rates in our auto insurance market are low.

This type of conservative, common-sense health-care reform can drive its opponents into ideological knots. Some conservatives are all for the pool -- so long as taxpayers fund it, not the insurance industry. Their assumption is that if taxpayers save money for the insurance industry by helping fund sick people who are expensive to insure, the resulting savings will be passed along to customers, and won't go into insurance industry profits and executive salaries.

And I've got a lighthouse for sale on our beautiful Outer Banks at a great price, just for you.

Another argument against the high-risk pool is that costs will fall on only a relatively small percentage of those insured because of a restriction in federal law that prevents states from requiring fees from so-called self-insured plans. This is where a company, instead of buying insurance from Blue Cross or another carrier, funds its own insurance plan.

The high-risk pool bill gets around this restriction by requiring not only insurers to pay, but also the companies that administer self-insured plans, plus reinsurance companies that provide additional insurance to self-insured plans. The Society of Professional Benefit Administrators estimates that 91 percent of self-insured plans use some sort of third-party administrator, so almost every health insurer in the state will share in the cost of the pool.

Finally, there's the effect of this reform on people who have insurance right now. With about 5 million people privately insured in North Carolina, either individually or through their employers, spreading the pool costs above the premiums paid by the 8,400 people estimated to enroll in the pool means minimal individual impact. Any cost is reduced even more under Rep. Insko's bill because the state does kick some funding into the pool, based on the number of people enrolled in the State Health Plan. Also, some federal funding will be used for pool administration.

A high-risk pool is the essential first step to building an economy where everyone can afford health insurance coverage. If we don't have an option for those with serious health conditions that are the most expensive to insure, costs go up for every other health reform proposal.

Each insured person already pays $438 a year in extra premium costs just to cover health care for North Carolinians without health insurance. Bringing at least some of these people into the health insurance market means more security for those with serious illnesses and their families, and more premium dollars available to cover the cost of everyone's care.

(Adam Searing is project director of the N.C. Justice Center's Health Access Coalition.)

All rights reserved. This copyrighted material may not be published, broadcast or redistributed in any manner.

Researchers identify defective molecule that triggers inflammatory bowel diseases

[Date: 2007-03-15]

Inflammatory bowel diseases such as Crohn's and Ulcerative Colitis are caused by a vicious cycle of inflammatory signals triggered by a defective signalling molecule, researchers have found.

The work, which was partly funded by the EU's Sixth Framework Programme, is published online by the journal Nature.

Inflammatory bowel diseases such as Crohn's affect more than four million people around the world. Symptoms of Crohn's disease include pain, diarrhoea, tiredness and weight loss. There is currently no cure for this debilitating condition, although it can be managed by steroids and immunosuppressants. Understanding the factors which trigger the inflammation of the bowel is a key focus of research into these diseases.

In this latest piece of research, scientists looked at the role of a signalling molecule called NF-kB, which has been implicated in a range of diseases with inflammatory components such as multiple sclerosis.

Our guts contain large numbers of bacteria which help us to digest our food. However, if they penetrate the wall of the intestine, they can cause diseases. To stop this happening, our intestines are lined with a layer of cells called an epithelium which acts as a barrier, keeping the bacteria where they belong inside the intestine.

To investigate the role of NF-kB in all this, the researchers created mice whose intestinal epithelial cells did not produce a protein called NEMO, which activates NF-kB. The mice went on to develop severe intestinal inflammation, similar to colitis in humans, and closer inspection revealed that their gut linings had been damaged, allowing bacteria into the walls of the intestine and triggering a vicious cycle of inflammatory signals which cause the symptoms of the disease.

'NF-kB acts as a survival signal for cells,' explained Manolis Pasparakis of the University of Cologne. 'Without the molecule cells are much more likely to die and this is what happened in the intestines of our mice; individual epithelial cells died, disrupting the gut lining.'

When bacteria break through the gut epithelium into the intestinal wall, they trigger a strong immune response from the intestinal immune system. Some of the signals sent out by the immune system bring about the symptoms of inflammation.

'This is where the vicious cycle closes,' commented Markus Neurath of the University of Mainz. 'Inflammatory signals also reach the epithelial cells that due to the lack of NF-kB are very sensitive to them and die. The death of more epithelial cells creates bigger gaps in the gut lining so that more bacteria enter. The result is a constant immune response leading to chronic inflammation as we know it from inflammatory bowel diseases in humans.'

As the immune systems of mice and humans are similar, the researchers hope their work will lead to the development of new treatments for these painful diseases.

For more information, please visit:

Category: Projects
Data Source Provider: European Molecular Biology Laboratory (EMBL) and Nature
Document Reference: Nenci, A. et al. (2007) Epithelial NEMO links innate immunity to chronic intestinal inflammation. Nature, published online 14 March 2007.
Subject Index: Coordination, Cooperation; Medicine, Health; Scientific Research

RCN: 27314

Wednesday, March 14, 2007

Lawsuit looms for Parexel over drug trial disaster

By Kirsty Barnes

13/03/2007 - Legal action could begin today against Parexel if the firm does not come up with "an adequate proposal" to compensate the victims of last years drug trial disaster in Northwick Park, London.

Lawyers representing four of the six injured men are poised to begin immediate legal proceedings if last minute talks being held today with the US-owned contract research organisation (CRO) fail.

Parexel was at the centre of the drug trial disaster last year after six out of eight men it carried out Phase I trials on - under contract on behalf of small German biotech firm TeGenero - experienced a severe and systemic adverse reaction and were admitted to intensive care with hours of taking the experimental drug.

The drug behind the fury is called TGN1412, a monoclonal antibody (mAb) that was being developed by TeGenero to treat conditions including multiple sclerosis, rheumatoid arthritis and leukaemia.

TeGenero has since gone bust and Parexel has been left to weather the ensuing storm.

How it is weathering it though, remains questionable, according to Gene Matthews, a solicitor from Leigh Day & Co solicitors - the London law firm representing four of the victims.

"Their response to us to date, and to the media for that matter, has been total silence," Matthews told

"Our clients got sick of waiting for Parexel to acknowledge them and so have now instructed us to commence legal proceedings. Only now after hearing this - one year after the event - have Parexel's lawyers agreed to sit down and talk with us to see if we can come up with some kind of compensation settlement."

According to Matthews, although Parexel was cleared of any blame in a subsequent UK Medicines and Healthcare products Regulatory Agency (MHRA) investigation, the CRO still has a case to answer for its role in the debacle.

"There are a number of issues surrounding the trial itself and the handling of the situation following the adverse reactions that we find questionable," he said.

Firstly there are questions over Parexel's involvement in the design of the trial.

"We don't know the extent of their involvement in the trial design yet but it is very likely that TeGenero - being a small German firm - relied on Parexel - a large international firm - for getting the protocol approved by the regulatory bodies and ethics committees," said Matthews.

Secondly, the issue of drug dosing is being scrutinised by the victims' lawyers.

"According to documents we have, the subjects were administered the trial drug at five- to eight-minute intervals. It is our understanding after speaking to a clinical immunologist and another industry expert that this was against good clinical practice (GCP) for this type of drug," said Matthews.

"They said that when testing a mAb for the first time, extra caution should be taken, including allowing sufficient time to wait for and deal with any sideeffects that may arise."

Thirdly, the lawyers believe that the way that Parexel staff dealt with the drug reactions was inadequate.

"It clearly states in the regulatory documents submitted by Parexel that cytokine release syndrome (which the six subjects suffered) was a possible consequence of the drug being tested," said Matthews.

The investigator's brochure also states that in the event of such a reaction, appropriate counter-measures - of which the application of high dose glucocorticoids or anti-histamines was suggested - must be taken, he said.

"However, the subjects did not receive high dose steroids until they were administered by the National Health Service (NHS) in intensive care 16-18 hours later," said Matthews.

"Our industry expert said that this delay in treatment worsened the health outcomes of our clients."

On the same subject, Matthews believes that Parexel should have informed the Northwick Park hospital of the type of drug it was testing before the trials started.

"The treating physicians at the hospital were in the dark - they had no idea what they were dealing with and this lad to delays in treatment."

"Our expert said testing on a drug of this type has a very high risk of a cytokine release syndrome reaction, and the hospital should have been forewarned so they could be prepared for a rapid response in the event of an emergency," said Matthews.

Parexel was asked by to comment but failed to do so.