Friday, April 13, 2007
Ex-employer ordered to pay disabled worker
Symptoms worse.
Canadian Press
Published: Friday, April 13, 2007
The B.C. Human Rights Tribunal has ordered Violetta Industries of Burnaby to pay a former employee almost $19,000 in compensation for refusing to accommodate his illness.
Dennis Chong has multiple sclerosis and was working a shift starting at 6 a.m. that allowed him to compensate for his chronic fatigue.
Four months after Chong started working for Violetta, his boss, Douglas Sommerville, found out Chong had MS.
Chong told a tribunal hearing Sommerville then changed his hours, turned down his request for paid leave and wouldn't accommodate his disability.
Tribunal member Barbara Junker ordered Violetta and Sommerville to pay Chong more than $11,000 in lost wages and $7,500 for injury to his dignity, feelings and self-respect.
Junker ruled that Sommerville's absolute refusal to accommodate Chong's illness caused Chong more stress and made his MS
© The Vancouver Province 2007
Canadian Press
Published: Friday, April 13, 2007
The B.C. Human Rights Tribunal has ordered Violetta Industries of Burnaby to pay a former employee almost $19,000 in compensation for refusing to accommodate his illness.
Dennis Chong has multiple sclerosis and was working a shift starting at 6 a.m. that allowed him to compensate for his chronic fatigue.
Four months after Chong started working for Violetta, his boss, Douglas Sommerville, found out Chong had MS.
Chong told a tribunal hearing Sommerville then changed his hours, turned down his request for paid leave and wouldn't accommodate his disability.
Tribunal member Barbara Junker ordered Violetta and Sommerville to pay Chong more than $11,000 in lost wages and $7,500 for injury to his dignity, feelings and self-respect.
Junker ruled that Sommerville's absolute refusal to accommodate Chong's illness caused Chong more stress and made his MS
© The Vancouver Province 2007
NEW ONE-YEAR PHARMACOECONOMIC STUDY SHOWS AVONEX® IS COST-EFFECTIVE RELATIVE TO OTHER INTERFERON THERAPIES FOR MULTIPLE SCLEROSIS
Cambridge, MA - April 13, 2007- Biogen Idec Inc. (NASDAQ: BIIB) announced today that one-year data presented at the Academy of Managed Care Pharmacy's (AMCP) 2007 Annual Meeting show that AVONEX® (Interferon beta-1a) is a cost-effective therapy in multiple sclerosis (MS) when compared to other interferon beta treatments. Using a comprehensive analysis of medical and pharmacy costs, the results of the research concluded that patients treated with AVONEX, the most prescribed MS therapy worldwide, have the lowest total one-year cost to a health plan when compared to other interferon beta treatments.
Researchers analyzed 10,622 patients over one year to assess how demographic, administrative and clinical variables affect MS costs and utilization patterns and to examine the economic impact of treating MS. The independent data contained in Multiple Sclerosis Benchmarksä , the retrospective, claims-based, observational study, showed that patients treated with AVONEX had the lowest average one-year cost compared to patients receiving other interferon beta treatments. It has been estimated that the total annual economic burden of MS in the United States exceeds $6.8 billion with a lifetime cost of $2.2 million per patient.
"MS is a disease that can have an impact beyond its debilitating effect on patients," said Michael Pollock, Vice President, Global Health Economics, Biogen Idec. "Cost-effectiveness is an increasingly important factor in treating chronic diseases like MS. This study shows that in addition to its clinical impact, AVONEX can also help to substantially reduce the cost of care for patients living with this disease, when compared to other interferon beta treatments."
The MS Benchmarks analysis showed the total costs over one-year to MS patients on interferon beta therapy were: AVONEX, $19,896.15; Rebif® (Interferon beta-1a) sc, $22,207.85; and Betaseron® (Interferon beta-1b), $21,073.33.
In addition, AVONEX patients were more likely to refill their prescriptions (avg.9.6/yr vs. 8.1 and 8.2/yr for other interferon beta therapies) and were less likely to use certain concomitant medications. Over the one-year period, use of disease-modifying therapies (interferon beta and glatiramer acetate) was almost always observed as monotherapy, reflecting little evidence of combination use or switching between products.
Additionally, according to data from the Quality Assessment of Multiple Sclerosis Therapy (QUASIMS) study presented at the AMCP Conference, patients do not derive additional clinical benefit from switching among interferon beta therapies. QUASIMS, an open-label, retrospective, observational study conducted in 14 countries, analyzed 7,156 MS patients who had received two years of uninterrupted therapy with interferon beta as initial therapy or follow-up therapy.
About AVONEX
AVONEX is the most prescribed treatment for relapsing forms of MS worldwide, with more than 130,000 patients on therapy. It was launched in the U.S. in 1996 and later in Europe for the treatment of relapsing forms of MS to slow the progression of disability and reduce relapses. AVONEX is marketed internationally in more than 90 countries. AVONEX was the first treatment approved for patients who have their first clinical MS attack and have a brain MRI scan consistent with MS; this use was approved in Europe in 2002 and in the U.S. in 2003.
The most common side effects associated with AVONEX multiple sclerosis treatment are flu-like symptoms, including myalgia, fever, fatigue, headache, chills, nausea, vomiting, pain and asthenia.
AVONEX should be used with caution in patients with depression or other mood disorders and in patients with seizure disorders. AVONEX should not be used by pregnant women. Patients with cardiac disease should be closely monitored. Patients should also be monitored for signs of hepatic injury. Routine periodic blood chemistry and hematology tests are recommended during treatment with AVONEX. Rare cases of anaphylaxis have been reported. Please see complete prescribing information available at www.AVONEX.com.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.
For more information contact:
Media Contacts:
Amy Brockelman
Associate Director, Public Affairs
Biogen Idec
(617) 914-6524
Biogen Idec Investment Community Contact:
Eric S. Hoffman
Associate Director, Investor Relations
Biogen Idec
(617) 679-2812
Thursday, April 12, 2007
Jefferson Immunology Researchers Show Blood-brain Barrier Damage Could Affect MS Severity
Immunology researchers at the Kimmel Cancer Center at Jefferson studying a multiple sclerosis (MS)-like disease in mice have shown that the amount of "damage" to the central nervous system's protective blood-brain barrier - in essence, opening it - almost always correlates to the severity of the disease. The findings, reported online in the Proceedings of the National Academy of Sciences, can be used for testing potential MS therapies and for better understanding the role of the blood-brain barrier in disease processes.
Scientists led by D. Craig Hooper, Ph.D., associate professor of cancer biology at Jefferson Medical College of Thomas Jefferson University in Philadelphia, and Hilary Koprowski, M.D., professor of cancer biology at Jefferson Medical College and director of Jefferson's Center for Neurovirology and the Biotechnology Foundation Laboratories, wanted to find out what factors might affect the onset and severity of EAE (experimental allergic encephalomyelitis), an MS-like autoimmune disease often used as a model. They studied various strains of mice, each lacking some genes associated with inflammation and immunity, and looked at what happened to the blood-brain barrier.
They discovered that the amount of blood-brain barrier damage and subsequent permeability increase correlated to the severity of disease, and surprisingly, in nearly every case, the mouse's genetic make-up didn't matter. The mice developed EAE even without supposedly crucial factors in inflammation and autoimmunity - and disease.
"We've now shown in all of these mice missing certain components of the immune system that, as expected, opening the blood-brain barrier and letting cells and factors in from the circulation is critical to the development of disease," Dr. Hooper says. "The fact that the extent of the permeability change correlates with the severity of clinical disease signs shows that this is an important element in determining how sick these animals can get.
"This puts an emphasis on the fact that blood brain permeability changes are an important aspect of the development of a CNS inflammatory disease like EAE, an animal model of MS," he says.
According to Dr. Hooper, previous studies by his group and other researchers have shown that blood-brain barrier permeability is critical in the development of MS. To study this permeability, he and his co-workers looked at a range of mice lacking certain genes for various types of immune system and inflammatory cells such as NF kappaB, TNF-alpha, and interferon alpha, beta and gamma that contribute to disease. The researchers established EAE in each mouse strain and examined what was common to all of the animals when they developed disease.
"What's astounding is that mice that wouldn't be expected to develop EAE because they have major defects in their immune system are still able to develop disease," though at different rates, he notes.
However, mice missing the immune protein TNF-alpha often did not show disease, despite the increase in brain barrier permeability, causing the scientists to speculate about its role in the disease. "This is the first proof that there are permeability changes in all of these animals and the first hint that permeability doesn't always equal disease," he says.
Dr. Hooper notes that the work is part of the long-range goal of determining the exact role of blood-brain barrier permeability in disease. "These results tell us a great deal about the mechanisms that damage the blood-brain barrier," he says. "All of these factors that are missing in the mice aren't essential to opening the blood brain barrier."
###
Contact: Steve Benowitz
Thomas Jefferson University
Wednesday, April 11, 2007
Nutra Pharma Announces ReceptoPharm Patent for a Method of Treating Multiple Sclerosis
Apr 11 2007, 9:30 AM EST
Nutra Pharma Corp. (OTCBB: NPHC), a biotechnology company that is developing drugs for HIV and Multiple Sclerosis has today announced that its drug discovery division, ReceptoPharm, has filed a patent for a method of treating autoimmune diseases, including Multiple Sclerosis (MS) and Rheumatoid Arthritis.
The patent discusses a method of treatment that uses ReceptoPharm's lead drug candidate, ReceptoPharm, to induce gamma-interferon and interleukin-27 (IL-27). IL-27 is a recently discovered and important anti-inflammatory regulator in cells of the immune system.
"We are pleased to announce this important discovery by ReceptoPharm," commented Rik J Deitsch, Chairman and CEO of Nutra Pharma Corporation. "Recently, larger biotechnology companies, including Genentech (NYSE: DNA), have shown interest in ways to control this pathway as a means to treat several autoimmune diseases. Some have even proposed the direct use of IL-27 to down regulate the autoimmune process," he added.
The ReceptoPharm patent provides a new way of controlling autoimmune diseases. Inducing IL-27 and gamma-interferon shut down the inflammation process by influencing the release of another interleukin, IL-17, that is a newly discovered component in maintaining the inflammation and autoimmune process.
"This discovery is significant to our continued research and development, as it identifies the mechanism of action for RPI-78M," explained Paul Reid, CEO of ReceptoPharm, Inc. "We believe that our drug is the first to induce the expression of IL-27, which represents a novel way to approach the treatment of several autoimmune diseases," he concluded.
In March, ReceptoPharm received notification of acceptance of its paper, entitled "Alpha-Cobratoxin as a possible therapy for Multiple Sclerosis; a review of the literature leading to its development for this application," for publication in the Critical Reviews in Immunology special conference issue. In addition, the Company recently announced its nonbinding letter of intent with Nanogene Biotechnology to create a joint venture in China aimed at developing its antiviral drug, RPI-MN, for the Chinese market.
About Nutra Pharma Corp.
Nutra Pharma Corp. is a biopharmaceutical company specializing in the acquisition, licensing and commercialization of pharmaceutical products and technologies for the management of neurological disorders, cancer, autoimmune and infectious diseases. Nutra Pharma Corp. through its subsidiaries carries out basic drug discovery research and clinical development and also seeks strategic licensing partnerships to reduce the risks associated with the drug development process. The Company's holding, ReceptoPharm, Inc, is developing technologies for the production of drugs for HIV and Multiple Sclerosis ("MS"). The Company's subsidiary, Designer Diagnostics is engaged in the research and development of diagnostic test kits designed to be used for the rapid identification of infectious diseases such as Tuberculosis (TB) and Mycobacterium avium-intracellulare (MAI). Nutra Pharma continues to identify and acquire intellectual property and companies in the biotechnology arena.
http://www.NutraPharma.com
http://www.ReceptoPharm.com
This press release contains forward-looking statements. The words or phrases "would be," "will allow," "intends to," "will likely result," "are expected to," "will continue," "is anticipated," "estimate," "project," or similar expressions are intended to identify "forward-looking statements." Actual results could differ materially from those projected in Nutra Pharma's ("the Company") business plan. The Company's business is subject to various risks, which are discussed in the Company's filings with the Securities and Exchange Commission ("SEC"). The recently filed ReceptoPharm patent for a method of treating autoimmune diseases should not be construed as an indication in any way whatsoever of the value of the Company or its common stock. The Company's filings may be accessed at the SEC's Edgar system at www.sec.gov. Statements made herein are as of the date of this press release and should not be relied upon as of any subsequent date. The Company cautions readers not to place reliance on such statements. Unless otherwise required by applicable law, we do not undertake, and we specifically disclaim any obligation, to update any forward-looking statements to reflect occurrences, developments, unanticipated events or circumstances after the date of such statement.
Pharmos Completes Phase 1 Study of Topical Diclofenac NanoEmulsion Cream
April 11, 2007 - 1:55 PM
Data Indicate Positive Results Achieved on Safety, Tolerability and Pharmacokinetics
ISELIN, N.J., Nov. 14 /PRNewswire-FirstCall/ -- Pharmos Corporation (NASDAQ:PARS) announced today it has completed its initial analysis of data from a recently completed Phase 1 study of its proprietary NanoEmulsion topical drug delivery technology formulated with diclofenac. Diclofenac is an approved and widely-used non-steroidal anti-inflammatory drug (NSAID). The analysis of the data indicates the formulation was safe and well tolerated with no severe or serious adverse events; subject compliance with the 14-day treatment period was excellent. In addition, the pharmacokinetic analysis demonstrated low systemic exposure of diclofenac with no drug accumulation following repeated daily administrations. These pharmacokinetic results in humans confirm the preclinical data previously obtained in animals showing reduced systemic plasma levels following topical administration of the NanoEmulsion cream.
Alan L. Rubino, President and COO, said, "Based on strong market demand for safe and effective delivery vehicles for medications, and analgesics in particular, we feel our NanoEmulsion technology may offer new value and be a timely therapeutic alternative in the US and other major markets given current treatment voids and patient needs in this disease category."
The single-center, open label, multiple-dose, topical application study included 16 healthy male and female volunteers. The trial evaluated the safety, tolerability and pharmacokinetic profile of 3% NanoEmulsion diclofenac topical cream following 14 days of three daily administrations and was conducted at Harrison Clinical Research in Munich, Germany.
Pharmos is developing the NanoEmulsion topical diclofenac cream as a potential treatment for Osteoarthritis (OA) pain. OA is a painful condition affecting more than 30 million people in the US, and is the most frequent cause of physical disability among adults, mainly elderly. Topical diclofenac is also being considered as treatment for soft tissue injuries, sprains and strains. It is estimated that 20% of OA patients are not receiving treatment, mainly due to gastrointestinal side effects of oral NSAIDs and cardiovascular risk of COX-2 inhibitors. A topical NSAID offering adequate pain relief targeted to the site of injury with an improved safety profile could become a treatment alternative for these patients. In the US, there are no approved topical NSAIDs for the treatment of OA.
Topical application of drugs directly to pathological sites offers potential advantages over systemic delivery by producing high drug concentration in the affected tissue while avoiding unwanted side-effects due to high systemic drug levels. Topical preparations of NSAIDs are commonly used as analgesics and anti-inflammatory agents to treat various disorders such as arthropathies and myalgias. Many topical formulations employ chemical penetration enhancers to improve dermal penetration of drugs. Chemical enhancers, which are usually organic solvents, may cause skin irritation and sensitization. An advantage of Pharmos' NanoEmulsion is that it is composed of natural lipids and oils designed to minimize irritation.
Pharmos' NanoEmulsion technology consists of an efficient solvent-free topical vehicle based on drug entrapment in stable, submicron particles of oil-in-water emulsions with a mean droplet size between 100 and 200 nm that are uniformly dispersed in an aqueous phase. One of the unique characteristics of the NanoEmulsion technology is the relatively high percentage of total particle volume occupied by the internal hydrophobic oil core of the droplets. This provides high solubilization capacity for lipophilic compounds compared to other lipoidal vehicles such as liposomes. Viscosity-imparting agents are used for NanoEmulsion thickening to produce creams with the desired semisolid consistency for application to the skin.
The skin penetrative properties of the solvent-free NanoEmulsion delivery technology and its low irritancy make this novel topical nanovehicle a promising candidate for effective transcutaneous delivery of lipophilic drugs. Pharmos owns a family of patents covering novel NanoEmulsion formulations as vehicles for localized delivery of lipophilic drugs. A topical application of the nanotechnology has already demonstrated excellent targeted delivery of lipophilic drugs to muscle and joints in animal models.
Preclinical data using a paw edema animal model showed enhanced anti- inflammatory activity with NSAIDs encapsulated in NanoEmulsion creams compared to commercial formulations. Pharmacokinetic studies using NanoEmulsion topical creams containing radiolabeled diclofenac and ketoprofen were performed to assess drug penetration through skin and to determine local tissue (muscle and joint) and plasma levels of drugs following topical administration. Compared to oral administration, diclofenac and ketoprofen administered via NanoEmulsion topical creams demonstrated 4-6 fold lower drug concentration in plasma, 60-80 fold more drug in muscle tissue, and about 9 fold more drug in joints.
The Company's NanoEmulsion containing diclofenac was also tested in a previous Phase 1 human skin irritancy study involving 25 healthy volunteers. No irritation or allergic responses were observed after topical application.
About Pharmos Corporation
Pharmos discovers and develops novel therapeutics to treat a range of indications including specific diseases of the nervous system such as disorders of the brain-gut axis (GI/IBS), pain/inflammation, and autoimmune disorders. The Company's lead product, dextofisopam, has completed Phase 2a testing in IBS, a common GI disorder particularly prevalent in women, with positive effect on primary efficacy endpoint (n=141, p=0.033). The Company plans a Phase 2b study of dextofisopam for the treatment of IBS in 2007. The Company's core proprietary technology platform focuses on discovery and development of synthetic cannabinoid compounds. Cannabinor, the lead CB2- selective receptor agonist candidate, is undergoing Phase 2a testing in pain. Other compounds in Pharmos' pipeline are in clinical and pre-clinical studies targeting pain, multiple sclerosis, rheumatoid arthritis and other disorders.
Safe Harbor Statement
Statements made in this press release related to the business outlook and future financial performance of the Company, to the prospective market penetration of its drug products, to the development and commercialization of the Company's pipeline products and to the Company's expectations in connection with any future event, condition, performance or other matter, are forward-looking and are made pursuant to the safe harbor provisions of the Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties which may cause results to differ materially from those set forth in these statements. Additional economic, competitive, governmental, technological, marketing and other factors identified in Pharmos' filings with the Securities and Exchange Commission could affect such results.
Source: Pharmos Corporation
CONTACT: Colin Neill, CFO, or Gale Smith, both of Pharmos U.S. at
+1-732-452-9556, or Irit Kopelov, Pharmos Israel, +011-972-8-940-9679; or John
Quirk, investors, +1-646-536-7029, or Janine McCargo, media, +1-646-536-7033,
both of The Ruth Group, Inc. for Pharmos Corporation
Web site: http://www.pharmoscorp.com/
XANTHUS ACQUIRES FROM JOHNS HOPKINS UNIVERSITY EXCLUSIVE LICENSE TO
- Research project to focus on Xanthus’ novel class of FLT3 inhibitors for autoimmune diseases - CAMBRIDGE, Mass., April 11, 2007 - Xanthus Pharmaceuticals, Inc. today announced that the company has acquired an exclusive worldwide license to a patent estate from Johns Hopkins University for treating immune-related disorders by inhibiting the FLT3 tyrosine kinase. FLT3 is highly expressed on dendritic cells, which are responsible for the stimulation of T cells. In preclinical studies conducted by Johns Hopkins researchers, FLT3 signaling modulated autoimmune responses, suggesting that inhibition of the FLT3 pathway may reverse the course and severity of autoimmune disease. Xanthus and Johns Hopkins have also initiated a research project to assess novel compounds for FLT3 inhibitory activity and the downstream pathways relevant to a range of autoimmune diseases. The research program will focus on a new class of compounds being developed by Xanthus,
imidazoacridinones, which includes Symadex™. Symadex™ is currently in Phase 2 clinical trials in oncology and Xanthus is exploring its use for the treatment of a number of autoimmune diseases where early preclinical studies have shown encouraging signs of activity.
“The group at Johns Hopkins is comprised of world-class leaders in the FLT3 field, including Drs. Katharine Whartenby and Donald Small, who discovered the role of FLT3 inhibitors in autoimmune disorders. This license deal and research project are important steps for Xanthus as we build upon our early findings that Symadex™ and our other imidazoacridinones have the potential to be developed into an important new class of autoimmune therapies,” said Michael A. Boss, Ph.D., Xanthus’ Chief Business Officer.
“Inhibiting dendritic cells by first blocking FLT3 would represent a novel way of treating immune-related disorders by stopping unwanted activity at its point of initiation. If successful, this approach would be a significant therapeutic improvement because it appears to leave the normal immune response intact,” said Alfred M. Ajami, Ph.D., Xanthus’ Chief Scientific Officer.
In a prior study from the Johns Hopkins researchers (PNAS, November 15, 2005, vol. 2, no. 46, 16741- 16746), inhibition of FLT3 signaling induced dendritic cell death in mice and in human cell cultures, making the FLT3 pathway a potential target for immune modulation. Additionally, FLT3 inhibition significantly improved the course of existing disease in a mouse model of multiple sclerosis, suggesting its potential as an autoimmune disease treatment. This latter finding from John Hopkins supports similar experimental observations reported recently by Xanthus and collaborating researchers.
About Xanthus Pharmaceuticals, Inc.
Xanthus Pharmaceuticals, Inc. is developing a portfolio of novel, clinical-stage, small-molecule therapeutic candidates through a management team whose accomplished track record encompasses all aspects of drug development, from discovery through regulatory approval and commercialization.
Xanthus is applying its expertise to advance its current pipeline to address significant unmet medical needs in oncology and autoimmune diseases.
Xanthus is headquartered in Cambridge, Massachusetts with an additional facility in Montreal, Quebec.
More information is available at www.xanthus.com.
This press release contains forward-looking statements concerning Xanthus that involve a number of risks and uncertainties. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words, "believes," "anticipates," "plans," "expects," "estimates," "intends," "should," "could," "will," "may," and similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause Xanthus’ actual results to differ materially from those indicated by such forward-looking statements, including risks as to whether results obtained in early clinical studies or in preclinical studies such as the studies referred to above will be indicative of results obtained in future preclinical studies or clinical trials or warrant clinical trials; whether products based on Xanthus’ technology will advance through the clinical trial process and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether the company will have the cash resources to develop and commercialize its products; and whether the patents and patent applications owned or licensed by Xanthus, such as the patents and patent applications licensed from Johns Hopkins University, will protect the Company’s technology and prevent others from infringing it. Xanthus disclaims any intention or obligation to update any forward-looking statements.
Contacts:
Kari Watson, MacDougall Biomedical Communications, Inc. – kwatson@macbiocom.com or (508) 647- 0209
Lisa Terry, Xanthus Pharmaceuticals, Inc. – lisa.terry@xanthus.com or (617) 225-0522, x 105
Novosom AG Acquires Exclusive Option for CD40-Targeted Antisense Inhibitors From Isis Pharmaceuticals
Apr 11 2007, 12:08 AM EST
PRNEWSWIRE
HALLE, Germany, April 11 /PRNewswire/ -- Novosom AG today announced that it has purchased an exclusive option from Isis Pharmaceuticals, Inc. that, if exercised within six months, enables it to acquire an exclusive, worldwide license to antisense inhibitors targeting the CD40 membrane protein for all indications. CD40 is a validated target for both inflammatory diseases and B-cell cancers and Novosom plans to target CD40 for indications such as Crohn's disease, transplant, rheumatoid arthritis, cancer and multiple sclerosis. If acquired, the license from Isis would include rights to the target and to oligonucleotides targeting CD40 and incorporating Isis' second generation antisense chemistry, 2' MOE oligonucleotides in exchange for financial considerations including an upfront exercise fee, milestone payments and royalties.
Novosom is using its proprietary Smarticles(R) technology to enable systemic delivery of antisense targeting CD40. This encapsulated antisense approach has demonstrated targeted delivery to specific cell types with a rapid onset of action and greater in vivo efficacy than the anti-inflammatory blockbuster Remicade.
Elias Papatheodorou, CEO of Novosom AG, commented:
"We are very happy to have reached an agreement with the industry leader in oligonucleotide therapeutics for Novosom's first proprietary therapeutic program. We feel that of the current oligo-based technologies, Isis' antisense 2' MOE chemistry offers the most commercially mature option. We plan to further extend our pipeline with antisense and siRNA programs while taking advantage of the targeted properties of our Smarticles(R) technology in oncology and inflammation."
"Novosom is pioneering new formulation chemistries to improve systemic delivery of RNA-based drugs, a powerful new class of therapeutics," said Dr. Frank Bennett, Isis Senior Vice President of Research. "This agreement underscores how Isis is leveraging its IP to form productive outlicensing partnerships. We look forward to collaborating further with Novosom on the development of a CD40 antisense oligonucleotide."
Dr. Steffen Panzner, Founder and CSO of Novosom AG, commented:
"We have chosen CD40 because it is a key molecule in the development of autoimmune and oncology indications and a license from Isis will give us the freedom to develop novel therapeutics based on their 2' MOE antisense agents. CD40 further adds to a growing list of therapeutic projects where our Smarticles(R) technology is used to enable the delivery of oligonucleotide therapeutics. The preclinical studies we have already conducted support a very favorable safety profile and our ability to transfect selected cell types at the site of disease with high specificity."
About Novosom
Novosom is working with its partners to develop unique antisense and siRNA based therapeutics with a current focus in inflammation, oncology and liver diseases. Novosom's Smarticles(R) liposomal vectors allow partners to deliver their active substance (siRNA, antisense, decoy etc) inside the cell either for topical or systemic applications. Smarticles are an enabler of systemic treatments and an enhancer of topical treatments. The Company has several active therapeutically-relevant collaborations in oncology and inflammation. Novosom AG main investors include IBG Beteiligungsgesellschaft Sachsen-Anhalt mbH and MBG Mittelstandische Beteiligungs-gesellschaft Sachsen Anhalt.
Notes to editors:
About CD40
CD40 is a membrane protein that is expressed on the antigen presenting cells (APCs) and facilitates integration of feedback signals from T cells via CD154 and danger signals from Toll-like receptors sitting on the APCs. Such signal integration is key to refine the antigen presentation and results in a straightforward immune response.
Novosom's Smarticles(R) / CD40 antisense combination has achieved targeted delivery that is specific to APCs.
In addition, CD40 provides critical signals for B cell proliferation meaning that Novosom researchers foresee an applicability in B cell cancers.
SOURCE Novosom AG
Treatment shows promise against diabetes
Tuesday, April 10, 2007 · Last updated 1:00 p.m. PT
By LINDSEY TANNER
AP MEDICAL WRITER
CHICAGO -- Thirteen young diabetics in Brazil have ditched their insulin shots and need no other medication thanks to a risky, but promising treatment with their own stem cells - apparently the first time such a feat has been accomplished.
Though too early to call it a cure, the procedure has enabled the young people, who have Type I diabetes, to live insulin-free so far, some as long as three years. The treatment involves stem cell transplants from the patients' own blood.
"It's the first time in the history of Type 1 diabetes where people have gone with no treatment whatsoever ... no medications at all, with normal blood sugars," said study co-author Dr. Richard Burt of Northwestern University's medical school in Chicago.
While the procedure can be potentially life-threatening, none of the 15 patients in the study died or suffered lasting side effects. But it didn't work for two of them.
Larger, more rigorous studies are needed to determine if stem cell transplants could become standard treatment for people with the disease once called juvenile diabetes. It is less common than Type 2 diabetes, which is associated with obesity.
The hazards of stem cell transplantation also raise questions about whether the study should have included children. One patient was as young as 14.
Dr. Lainie Ross, a medical ethicist at the University of Chicago, said the researchers should have studied adults first before exposing young teens to the potential harms of stem cell transplant, which include infertility and late-onset cancers.
In addition, Ross said that the study should have had a comparison group to make sure the treatment was indeed better than standard diabetes care.
Burt, who wrote the study protocol, said the research was done in Brazil because U.S. doctors were not interested in the approach. The study was approved by ethics committees in Brazil, he said, adding that he personally believes it was appropriate to do the research in children as well as adults, as long as the Brazilian ethics panels approved.
Burt and other diabetes experts called the results an important step forward.
"It's the threshold of a very promising time for the field," said Dr. Jay Skyler of the Diabetes Research Institute at the University of Miami.
Skyler wrote an editorial in the Journal of the American Medical Association, which published the study, saying the results are likely to stimulate research that may lead to methods of preventing or reversing Type I diabetes.
"These are exciting results. They look impressive," said Dr. Gordon Weir of Joslin Diabetes Center in Boston.
Still, Weir cautioned that more studies are needed to make sure the treatment works and is safe. "It's really too early to suggest to people that this is a cure," he said.
The patients involved were ages 14 to 31 and newly diagnosed with Type 1 diabetes. An estimated 12 million to 24 million people worldwide - including 1 to 2 million in the United States - have this form of diabetes, which is typically diagnosed in children or young adults. An autoimmune disease, it occurs when the body attacks insulin-producing cells in the pancreas.
Insulin is needed to regulate blood sugar levels, which when too high, can lead to heart disease, blindness, nerve problems and kidney damage.
Burt said the stem cell transplant is designed to stop the body's immune attack on the pancreas.
A study published last year described a different kind of experimental transplant, using pancreas cells from donated cadavers, that enabled a few diabetics to give up insulin shots. But that requires lifelong use of anti-rejection medicine, which isn't needed by the Brazil patients since the stem cells were their own.
The 15 diabetics were treated at a bone marrow center at the University of Sao Paulo.
All were newly diagnosed, before their insulin-producing cells had been destroyed.
That timing is key, Burt said. "If you wait too long," he said, "you've exceeded the body's ability to repair itself."
The procedure involves stimulating the body to produce new stem cells and harvesting them from the patient's blood. Next comes several days of high-dose chemotherapy, which virtually shuts down the patient's immune system and stops destruction of the few remaining insulin-producing cells in the body. This requires hospitalization and potent drugs to fend off infection. The harvested stem cells, when injected back into the body, build a new healthier immune system that does not attack the insulin-producing cells.
Patients were hospitalized for about three weeks. Many had side effects including nausea, vomiting and hair loss. One developed pneumonia, the only severe complication.
Doctors changed the drug regimen after the treatment failed in the first patient, who ended up needing more insulin than before the study. Another patient also relapsed.
The remaining 13 "live a normal life without taking insulin," said study co-author Dr. Julio Voltarelli of the University of Sao Paulo. "They all went back to their lives."
The patients enrolled in the study at different times so the length of time they've been insulin-free also differs.
Burt has had some success using the same procedure in 170 patients with other autoimmune diseases, including lupus and multiple sclerosis; one patient with an autoimmune form of blindness can now see, Burt said.
"The body has tremendous potential to repair," he said.
The study was partly funded by the Brazilian Ministry of Health, Genzyme Corp. and a maker of blood sugar monitoring products.
---
AP reporter Carla K. Johnson in Chicago contributed to this report.
---
On the Net:
JAMA: http://jama.ama-assn.org
Juvenile Diabetes Research Foundation: http://www.jdrf.org
New BIO Study Confirms Innovative Therapies Will Have Minimal Impact on Healthcare Costs
Apr 10 2007, 12:46 PM EST
Business Wire
The widening use of new, innovative biopharmaceutical treatments for diseases, such as cancer, multiple sclerosis and heart disease, will have a limited impact on healthcare costs for private healthcare payers over the next several years, according to an independent study released today by the Biotechnology Industry Organization (BIO).
"This well-researched analysis by one of the world's most respected healthcare actuarial firms is good news for millions of patients who look to the biotechnology industry for revolutionary new therapies for some of society's most devastating diseases," said BIO President and CEO Jim Greenwood. "This study underscores the reality that access to innovative therapies, and consequently hope, is within their reach."
The study, prepared by the international actuarial firm Milliman, Inc. and titled Realizing the Value of FDA-Approved Therapies, found new innovative therapies, including both new drugs and biologics, will add 1 percent to the healthcare costs covered by private commercial payers, such as insurance companies and employer-sponsored health plans. This increase translates to an additional claims cost to private payers of about $5.00 per member per month.
Moreover, the study found that private payers can make minor changes in their benefit plans to assure the affordability of innovative therapies for their members.
The Milliman study reports that the costs of innovative therapies will generally not create a large cost burden relative to other costs for private healthcare payers by 2011. The total cost for all innovative therapies (existing and new) approved by the U.S. Food and Drug Administration (FDA) is estimated to be about 6 percent of total private commercial payer costs by 2011. This compares to about 5 percent for 2006.
"The largest healthcare expense borne by payers is not prescription drug and biologic costs but hospital and other non-drug costs," stated Bruce Pyenson, Principal and Consulting Actuary, Milliman, and author of the report. "While prescription drug costs account for about 14 percent, non-drug costs account for 86 percent of expense borne by payers, according to Milliman's 2006 Group Health Insurance Survey of HMOs."
The study points out that innovative therapies may actually bring down health care costs in some cases. The report notes that new and improved medical treatment does not necessarily cost more than traditional treatment: "The current standard of care for certain diseases can be very expensive. Therefore, treatments that replace or modernize the traditional standard of care can reduce a patient's medical costs, even if the new treatments are themselves very expensive." As an example, the study said the cost of a hypothetical product that would prevent or cure Alzheimer's disease would help a patient avoid years of very costly nursing home care. "Even if the therapy is expensive," the study said, "it will be cheaper than years of institutional care."
"This study confirms our long-held belief that the cost of innovative therapies, including biologics, has a limited impact on overall health care costs," said Greenwood. "We hope Congress will look to this data as definitive research as it considers proposals to reduce health care costs. We must be careful we do not inadvertently undermine the ability of the biotechnology industry to develop and deliver innovative biopharmaceutical therapies to the patients who so desperately need them to gain nominal cost savings that do little to impact the aggregate cost of health care."
The study can be accessed at http://www.bio.org/healthcare/value/MillimanReport.pdf.
About BIO
BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and 31 other nations. BIO members are involved in the research and development of healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the annual BIO International Convention, the global event for biotechnology.
Modified bone marrow cells can help recovery in an animal model of multiple sclerosis
A new study published in PLoS Medicine has shown that modified bone marrow cells can help recovery in an animal model of multiple sclerosis (MS). Harald Neumann and colleagues from the University of Bonn modified myeloid precursor cells to express a protein (triggering receptor expressed on myeloid cells-2 (TREM2), which is normally made by microglia - a cell from the nervous system - and injected these TREM2-expressing cells into the veins of mice with experimental autoimmune encephalomyelitis (EAE, an animal model of MS).
The researchers examined the migration of these cells into the spinal cord of the mice, their effect on the symptoms of EAE, and what effect there was on the clearance of cell debris and inflammatory responses in the spinal cord of the mice. They found that neither TREM2-expressing nor control myeloid precursor cells migrated into the spinal cord when injected into healthy mice or into animals just beginning to show the symptoms of EAE. However, both control and modified cells migrated into the spinal cord when injected into animals when EAE symptoms were at their peak. The injection of TREM2-expressing myeloid precursor cells (but not control myeloid precursor cells) at this time reduced EAE symptoms and nerve damage, and halted loss of myelin and also increased the clearance of cell debris and myelin fragments.
These findings will need to be repeated in further animal models before the implications for human disease are clear; however, they open up an avenue of further research.
###
Citation: Takahashi K, Prinz M, Stagi M, Chechneva O, Neumann H (2007) TREM2-transduced myeloid precursors mediate nervous tissue debris clearance and facilitate recovery in an animal model of multiple sclerosis. PLoS Med 4(4): e124.
PLEASE ADD THE LINK TO THE PUBLISHED ARTICLE IN ONLINE VERSIONS OF YOUR REPORT: http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0040124
PRESS-ONLY PREVIEW OF THE ARTICLE: http://www.plos.org/press/plme-04-04-neumann.pdf
Related image for press use: http://www.plos.org/press/plme-04-04-neumann.jpg
- Caption: TREM2-transduced myeloid precursors (green) facilitating tissue debris clearance in an inflammatory spinal cord lesion of experimental autoimmune encephalomyelitis
Public release date: 9-Apr-2007
[ Print Article | E-mail Article | Close Window ]
Contact: Andrew Hyde
press@plos.org
44-122-346-3330
Public Library of Science
CONTACT:
Harald Neumann
Institute of Reconstructive Neurobiology/ Uni Bonn
Neural Regeneration
Sigmund-Freud-Str. 25
Bonn, NRW 53127
Germany
+49.228.6885.541
hneuman1@uni-bonn.de
About PLoS Medicine:
PLoS Medicine is an open access, freely available international medical journal. It publishes original research that enhances our understanding of human health and disease, together with commentary and analysis of important global health issues. For more information, visit http://www.plosmedicine.org
About the Public Library of Science:
The Public Library of Science (PLoS) is a non-profit organization of scientists and physicians committed to making the world's scientific and medical literature a freely available public resource. For more information, visit http://www.plos.org
Monday, April 09, 2007
Israeli-developed auditory device makes walking easier for MS patients
By David Brinn April 08, 2007
A Technion Institute computer science researcher has devised an auditory feedback system which enables patients with multiple sclerosis (MS) to improve their gait.
Professor Yoram Baram said that the apparatus, which is an updated version of a virtual reality visual feedback apparatus he developed a decade ago, can also help Parkinson's disease patients walk better.
"Our earlier system was based on a visual feedback device - this one is an auditory feedback device that has a visual element to it," he explained to ISRAEL21c. "The apparatus we built is the size of a Walkman and is worn on a belt. It measures body movement, processes it using a computer and then sends a signal to the ears through earphones."
According to Baram, auditory feedback helps patients walk at a fixed pace because gait quality is expressed through a series of sounds that a person hears while walking.
"The user hears a ticking sound which is synchronized to his steps, rather than hearing a rhythm track and having to respond to it. Now he hears his own steps. If the patient doesn't have a balanced, steady walk, all he needs to do is produce his own rhythm as an auditory cue," he said.
The 400,000 Americans suffering from MS, lack a simple, but integral element that healthy people have to control their walking - sensory feedback from muscle nerves, which report on muscle control, telling them if they are using their muscles correctly or not.
"This feedback is damaged in Parkinson and MS patients and the elderly. Parkinson's results from the production of dopamine in the brain which affects muscle function, and MS develops when the patient's immune system attacks the white matter nerves in the brain," said Baram.
The most common neurological disorder diagnosed in young adults, MS affects eyesight, mobility, bladder and bowel control, and causes chronic pain and dizziness.
Together with Prof. Ariel Miller of the Technion's Rappaport Faculty of Medicine and the Multiple Sclerosis and Brain Research Center at the Carmel Medical Center in Haifa, Baram examined the influence of the auditory/visual apparatus on the gait quality of MS patients. Their work was recently published in the important scientific publication, Journal of the Neurological Sciences.
In the study, on-line (device on) and residual short-term therapeutic effects on walking speed and stride length were measured in 14 randomly selected MS patients with gait disturbances. The results showed an average improvement of 12.84% on-line and 18.75% residually in walking speed. Average improvement in stride length was 8.30% on-line and 9.93% residually. According to Baram, the improvement results are particularly noteworthy when compared with the lack of change in healthy control subjects.
Baram says that the virtual reality visual feedback apparatus developed 10 years ago influences more stride length while the auditory apparatus influences walking speed. Now that both devices have been integrated, the patient wears the visual feedback apparatus on his eyes and the earphones are connected to it.
"Our findings also raise the possibility of understanding the processes that go on in the brain when processing the sensory information reaching it," he adds.
Baram recently returned to the Technion after spending a year in the US conducting research on the device with MS and Parkinson's patients at the Neuroscience Institute at the University of Cincinnati, as well as at the Parkinson's Institute at Stanford University in California.
"The device has been tested at all those places and the preliminary results are very good. We received very positive response from our colleagues at those institutions," he said.
Baram, who holds a PhD in electrical engineering and computer science from MIT, once designed a mechanism for the U.S. National Aeronautics and Space Administration that helped helicopters navigate at low altitudes around obstacles such as electrical poles and trees. Several years after his work for NASA he was watching television and heard a man with Parkinson's describe how he found it easier to walk on a tiled floor since the grid pattern made the image more stable.
Baram made a connection between his work for NASA and the Parkinson's patient's description. The design Baram later used for the visual device was based on the idea that optical images of fixed objects help people stabilize themselves, whether they are walking or flying a helicopter.
One patient who tested the audio/visual system was Jack Rose, a 77-year-old Parkinson's patient from outside Cincinnati. He told The Cincinnati Enquirer that the grid "makes you feel like you have something to step over," which makes it easier to take that first step.
At the neurology clinic, Rose and other study subjects walked on a special mat equipped with sensors that measure how fast they walk and the length of their steps.
The information was fed into a computer so researchers could track people's progress. Rose's data showed his steps were short and close together at the start of the study session, and longer and faster at the end of it, indicating his progress from a slow shuffle to an easy, natural stride.
According to Baram, the main reason for developing the auditory element of the device is because many of the patients are also handicapped by poor eyesight, for which the audio device compensates.
"Some people don't see very well, and this provides an auditory channel option. In addition, the rhythmic sound device is less expensive than the relatively costly visual display," he said, adding that the combined device would probably cost in the area of $1,000.
Now ensconced back at the Technion, Baram is concentrating on conducting further testing of the auditory/visual device and looking forward to the day when MS and Parkinson's patients will be walking steadier.
MultiCell Technologies Signs Key Supply Agreement With Lundbeck Pharmaceuticals Italy S.p.A.
Apr 09, 2007 SAN DIEGO, CA MARKET WIRE
MultiCell Technologies, Inc. (OTCBB: MCET) has entered into a long-term agreement with Lundbeck Pharmaceuticals Italy S.p.A. for the supply of one of the active components of MCT-125, MultiCell's Phase IIb drug for the treatment of chronic fatigue in patients with multiple sclerosis (MS).
Multiple sclerosis is an autoimmune disease in which immune cells attack and destroy the myelin sheath protecting neurons in the brain and spinal cord. About two million people worldwide are afflicted with MS, and an estimated 10,000 new MS cases are diagnosed yearly in the USA. Over 75% of MS sufferers report chronic fatigue, and 50% to 60% report chronic fatigue as the worst symptom of their disease. Chronic fatigue severely affects an individual's quality of life. In approximately 30% of MS patients, chronic fatigue is the first symptom, and there is no FDA-approved treatment available for this disease.
In a 138-patient, multi-center, double-blind placebo controlled Phase II clinical trial conducted in the UK by Amarin, MCT-125 (then known as LAX-202) demonstrated efficacy in significantly reducing the levels of fatigue in MS patients enrolled in the study. MCT-125 demonstrated effectiveness within 4 weeks of the first daily oral dosing, and showed efficacy in all MS patient sub-populations including relapsing-remitting, secondary progressive and primary progressive. Patients enrolled in the Phase II trial conducted by Amarin also reported few if any side effects following daily oral dosing of MCT-125.
"We are pleased to have the opportunity to work with an outstanding company like Lundbeck Pharmaceuticals Italy, and look forward to a long-term relationship. This contract is enabling, and helps us advance MCT-125 toward commencement of our planned Phase IIb human clinical trials," stated Dr. Stephen Chang, President and CEO of MultiCell Technologies.
About Lundbeck
Lundbeck Pharmaceuticals Italy S.p.A. is an FDA-inspected manufacturer of proprietary APIs and cGMP intermediates for the pharmaceutical, veterinary, and life science industries. Lundbeck Pharmaceuticals Italy offers contract manufacturing services to many large multinational pharmaceutical companies. Lundbeck Pharmaceuticals Italy covers the entire life cycle of pharmaceutical products: Product Launches -- new chemical entities development and production by novel chemistry; and, mature products -- APIs and intermediates manufacturing by established/optimized chemistry.
About MultiCell Technologies
MultiCell Technologies, Inc. is developing first-in-class drugs based on advanced immune system modulation technologies, and is an integrated biopharmaceutical company committed to the development of breakthrough therapeutics based on a portfolio of therapeutic candidates and patented drug development technologies. MultiCell's drug development program focuses on modulation of the immune system.
MultiCell's therapeutic pipeline includes:
MCT-125 a Phase IIb drug for the treatment of chronic fatigue in MS
patients.
MCT-175 for the treatment of relapsing-remitting MS.
MCT-275 for the treatment of juvenile diabetes.
MCT-465 for the treatment of virus infection and cancer.
MCT-475 for the treatment of colorectal cancer.
The Company also holds unique cell-based technology for use in drug discovery screening applications, and is a leading producer of the cell lines needed by the pharmaceutical industry to develop new drugs. For more information about MultiCell Technologies, please visit http://www.multicelltech.com.
Caution Regarding Forward-Looking Statements
Any statements in this press release about MultiCell's expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and are forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). These statements are often, but not always, made through the use of words or phrases such as "believe," "will," "expect," "anticipate," "estimate," "intend," "plan," "forecast," "could," and "would." Examples of such forward-looking statements include statements regarding the timing, design, scope, and anticipated results of our clinical development programs. MultiCell bases these forward-looking statements on current expectations about future events. They involve known and unknown risks, uncertainties and assumptions that may cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by any forward-looking statement. Some of the risks, uncertainties and assumptions that could cause actual results to differ materially from estimates or projections in the forward-looking statement include, but are not limited to, the risk that we might not achieve our anticipated clinical development milestones, receive regulatory approval, or successfully commercialize our products as expected, the market for our products will not grow as expected, and the risk that our products will not achieve expectations. For additional information about risks and uncertainties MultiCell faces, see documents MultiCell files with the SEC, including MultiCell's report on Form 10-KSB for the fiscal year ended November 30, 2006, and all our quarterly and other periodic SEC filings. MultiCell claims the protection of the safe harbor for forward-looking statements under the Act and each assume no obligation and expressly disclaim any duty to update any forward-looking statement to reflect events or circumstances after the date of this news release or to reflect the occurrence of subsequent events.
Contact:
MultiCell Technologies, Inc.
Dr. Stephen Chang
CEO
(401) 333-0610
MCETInvestor@MultiCelltech.com
SOURCE: MultiCell Technologies, Inc.
Thursday, April 05, 2007
Medical pot bill passes; foes urge more legislation
RACHEL LA CORTE
The Associated Press
The state House late Wednesday passed a measure clarifying the state's medical marijuana law and addressing supply issues, but medical marijuana advocates and patients opposed to the measure argue it does nothing to help them.
The measure, which was passed on a 64-30 vote, requires the state Department of Health to determine the quantity of marijuana that could reasonably be considered a 60-day supply. The bill passed the Senate last month, but because it was amended in the House, it must go back to the Senate for concurrence.
Steve Sarich, executive director of CannaCare, a medical marijuana advocacy group, said that doctors - not the state - should determine the supply a patient needs.
"Does the state determine how many birth control pills you take, or how much Percocet you need?" he asked.
Initiative 692 passed with 59 percent voter approval in 1998. It gives doctors the right to recommend - but not prescribe - marijuana for people suffering from cancer, AIDS, multiple sclerosis, glaucoma and other conditions that cause "intractable pain."
But state law limits the amount of marijuana an individual can possess for medical use to a 60-day supply. People found with marijuana still can be arrested, but if they prove it's for medical purposes they can avoid being charged with a crime in the state system. That does not protect them from federal prosecution, however.
But Sarich said the bill is lacking.
"This bill provides no significant protection for patients whatsoever," he said.
The measure also would require the Health Department to come up with recommendations on how the state can provide safe access to marijuana for patients and present those suggestions to the Legislature in July 2008.
Sarich said he and others were upset that key elements of the original bill were removed in the Senate, including a provision that would have allowed cooperative growing operations. Senate Bill 6032
The Associated Press
The state House late Wednesday passed a measure clarifying the state's medical marijuana law and addressing supply issues, but medical marijuana advocates and patients opposed to the measure argue it does nothing to help them.
The measure, which was passed on a 64-30 vote, requires the state Department of Health to determine the quantity of marijuana that could reasonably be considered a 60-day supply. The bill passed the Senate last month, but because it was amended in the House, it must go back to the Senate for concurrence.
Steve Sarich, executive director of CannaCare, a medical marijuana advocacy group, said that doctors - not the state - should determine the supply a patient needs.
"Does the state determine how many birth control pills you take, or how much Percocet you need?" he asked.
Initiative 692 passed with 59 percent voter approval in 1998. It gives doctors the right to recommend - but not prescribe - marijuana for people suffering from cancer, AIDS, multiple sclerosis, glaucoma and other conditions that cause "intractable pain."
But state law limits the amount of marijuana an individual can possess for medical use to a 60-day supply. People found with marijuana still can be arrested, but if they prove it's for medical purposes they can avoid being charged with a crime in the state system. That does not protect them from federal prosecution, however.
But Sarich said the bill is lacking.
"This bill provides no significant protection for patients whatsoever," he said.
The measure also would require the Health Department to come up with recommendations on how the state can provide safe access to marijuana for patients and present those suggestions to the Legislature in July 2008.
Sarich said he and others were upset that key elements of the original bill were removed in the Senate, including a provision that would have allowed cooperative growing operations. Senate Bill 6032
Breakthrough multiple sclerosis treatment doesn't reach US patients
Many US multiple sclerosis (MS) patients aren't receiving the latest drug therapies, according to research published in the online journal BMC Medicine. Immunomodulatory agents (IMAs) could slow the progress of the disease, but are only prescribed in a minority of cases, and mostly by neurologists.
Jagannadha Avasarala from Kansas Neurological Consultants, Wichita analysed treatment trends between 1998 and 2004 for all Federal Drug Administration (FDA) approved IMA drugs, together with colleagues from Wake Forest University School of Medicine, NC, and Ohio State University Medical Center. They used National Ambulatory Medical Care Survey (NAMCS) data to evaluate prescribing trends as well as type of physician and geographic location.
Avasarala found that an estimated 6.7million MS patient visits occurred during the study timescale: 3.4 visits per 1000 persons each year. Women were seen four times as often as men and Caucasians had a higher visit rate than African Americans (90% vs 8%). This may because MS is more prevalent amongst Caucasian women than any one ethnic group. Neurologists prescribed IMAs more often than family practitioners or internists, with urban patients visited neurologists than their rural counterparts. The NAMCS data showed that 62% of established MS patients evaluated by neurologists and 92% of those seeing family medicine practitioners or internists were not being treated with IMAs. The higher treatment rate among neurologists probably reflects greater awareness of these drugs and familiarity with MS cases.
"Strategies for educating both neurologists and non-neurologists about the benefits of initiating IMA use in MS patients and in continuing their use remain critical to improving long-term patient outcomes in treatment of MS" Says Avasarala.
MS is among the leading causes of disability in young adults, and accumulates over time. IMAs can reduce the frequency of new lesions, relapses and the rate of cerebral atrophy.-BioMed Central
Partnership for Prescription Assistance Celebrates Two Year Anniversary; Helps 3.6 Million Uninsured Patients Across United States
WASHINGTON, April 05, 2007 /PRNewswire/ -- Reaching a new milestone, the Partnership for Prescription Assistance (PPA) today celebrates its two year anniversary of focusing attention on patient assistance programs that provide free or nearly free medicine to struggling Americans who are uninsured or underinsured. Sponsored by America's pharmaceutical research companies, the PPA has already helped more than 3.6 million people nationwide, but millions of additional people could potentially qualify for assistance.
"We are proud of the PPA's accomplishments over the past two years. But today we are expanding our efforts to make sure patients who need help are aware of the many programs available to them," said Billy Tauzin, President and CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA). "We are 100 percent committed to finding ways to help Americans live longer, healthier and more productive lives."
Through a toll-free number (1-888-4PPA-NOW) and user-friendly Web site (http://www.pparx.org), the PPA provides a single point of access to more than 475 public and private patient assistance programs that could offer help on more than 2,500 prescription medicines, including a wide range of generics. In addition, the PPA provides information on nearly 10,000 free healthcare clinics and has connected more than 135,000 patients with clinics and health care providers in their communities.
The bright orange "Help is Here Express" buses -- the PPA's traveling education centers -- are being featured today at events in Las Vegas, Nevada and Jackson, Mississippi. In Las Vegas, the PPA's national spokesman and Emmy-winning syndicated talk show host Montel Williams will attend the event. On the other side of the country in Jackson, PhRMA representatives will join local officials to make sure Mississippians are aware of the help that is available to them. Since its launch in April 2005, the "Help is Here Express" buses have visited all 50 states, more than 1,200 cities, and traveled over 150,000 miles helping people in need.
"The PPA continues to transform the lives of millions of patients in need," said Williams. "I am very fortunate to be able to get all the medications I need to battle my multiple sclerosis. Unfortunately, many patients do not have the same access, and that is why the PPA is such a critically important resource for patients that need help accessing their medicines."
More than 1,300 national and local organizations, including the American Academy of Family Physicians, American Cancer Society, Easter Seals, National Urban League and the National Association of Chain Drug Stores, are working with America's pharmaceutical research companies to help spread the word about the PPA.
For additional information on patient assistance programs that may meet their needs, patients should call toll-free 1-888-4PPA-NOW (1-888-477-2669) to speak with a trained specialist or visit http://www.pparx.org.
CONTACT: Ed Belkin of Partnership for Prescription Assistance,+1-202-835-3460
Web site: http://www.pparx.org/
Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company
Wednesday, April 04, 2007
Chromos announces demand for bridge loan repayment
BURNABY, BC, April 3 /CNW/ - Chromos Molecular Systems Inc. ("Chromos") (TSX:CHR) announced today that the holders of the convertible, secured bridge loan have demanded repayment of the principal and interest, totaling approximately $2,242,000, by April 4, 2007. Chromos does not currently have sufficient funds to satisfy this demand.
The Company is attempting to arrange financing to satisfy this demand for repayment and exploring other strategic alternatives. There can be no assurance 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 sufficient financing it will be required to scale back or terminate certain or all of its operations.
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 www.chromos.com.
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 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; (*) the demand for repayment of the outstanding Notes by the Noteholders 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, (604) 415-7132, email: jcharpentier@chromos.com
The Company is attempting to arrange financing to satisfy this demand for repayment and exploring other strategic alternatives. There can be no assurance 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 sufficient financing it will be required to scale back or terminate certain or all of its operations.
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 www.chromos.com.
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 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; (*) the demand for repayment of the outstanding Notes by the Noteholders 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, (604) 415-7132, email: jcharpentier@chromos.com
The Immune Response Corporation Announces Rebranding to Reflect Expanded Focus on Treatment of Autoimmune Diseases
Apr 4 2007, 12:00 AM EST
CARLSBAD, Calif., April 4 /PRNewswire-FirstCall/ -- The Immune Response Corporation (OTC Bulletin Board: IMRP) announced today that effective April 16 the company will be known as Orchestra Therapeutics, Inc. This new corporate identity reflects the Company's expanded focus on the treatment of autoimmune diseases. The Company will announce a new ticker symbol prior to April 16.
"This is a transformative moment in the Company's history," said Dr. Joseph O'Neill, President and CEO of The Immune Response Corporation. "We believe we have a substantial opportunity to benefit patients living with autoimmune diseases by concentrating our resources and further leveraging the scientific technology pioneered with our investigational MS therapy NeuroVax(TM)."
Autoimmune processes are implicated in more than 60 conditions, including multiple sclerosis (MS), rheumatoid arthritis (RA), Crohn's disease, psoriasis, lupus and type-1 diabetes. Orchestra Therapeutics' unique approach to controlling autoimmune diseases uses small peptide vaccines that appear to stimulate FOXP3+ Regulatory T-cells; a component of the immune system that is now recognized as being key in autoimmune pathogenesis.
In MS, for example, 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(TM), an investigational T-Cell Receptor peptide vaccine for the treatment of relapsing-remitting forms of MS, appears to work by enhancing levels of FOXP3+ Regulatory T-cells within the immune system, which may help control levels of pathogenic T-cells in MS patients. Data from the Company's most recent Phase II clinical trial in MS showed that reduced levels of FOXP3 can be restored to normal levels after repeated vaccinations with NeuroVax(TM). The Company recently announced the injection of the first patient in a large multi-center Phase II study to assess the safety and efficacy of NeuroVax(TM).
Recognizing that a growing base of scientific research has demonstrated the potential significance of the role of FOXP3+ Regulatory T-cells in the prevention and treatment of a variety of autoimmune diseases, the Company has made a strategic decision to emphasize this program and will redirect its resources toward the execution and expansion of product development in this area.
The Company is in discussions with several academic institutions to conduct pre-clinical work on therapeutic vaccines to treat psoriasis and RA. Based on findings to be derived from these product development programs, the Company plans to initiate Phase I trials in one of these new autoimmune areas in 2008.
The transition to the new name coincides with the Company's decision to terminate the HIV clinical trials to fully focus the weight of the Company's resources on the autoimmune program. The 52-week data from the first large cohort of HIV clinical-trial participants have already been gathered, and analysis of the data will be completed and disclosed in the second quarter of 2007. Based on this data, the Company will consider strategic alternatives for the HIV program.
Additionally the Company has decided to scale back operations at its manufacturing facility in King of Prussia, Pennsylvania, effective immediately. This decision will reduce costs by approximately $3 million per year, while allowing the Company to maintain the facility pending strategic decisions about the HIV program.
The Company raised $902,000, gross, from the exercise of warrants in the last week of March 2007. These were from the second tranche of warrants issued in the Company's spring 2006 Private Placement. Under special amended terms, each exercising warrant holder received 2.5 common shares for each $2 of exercise price paid. A total of 5,530,125 second tranche warrants expired on March 30, thereby significantly reducing the Company's overhang.
Orchestra Therapeutics, which will soon be the new name of The Immune Response Corporation (OTC Bulletin Board: IMRP), is an immuno-pharmaceutical company focused on the discovery and development of novel treatments for autoimmune diseases. The Company's lead immune-based therapeutic product candidate is NeuroVax(TM) for the treatment of MS. In addition to MS, the Company has proprietary technology and prior clinical experience for clinical evaluation of TCR peptide-based immune-based therapies for RA and psoriasis. The targeted strategy behind the Company's autoimmune therapies is reflected in the name Orchestra. Rather than disrupting the function of the entire immune system, these therapeutic vaccines are designed to elicit a very specific response -- akin to correcting one instrument in an orchestra that is out of tune -- to help control disease.
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 clinical trials of NeuroVax(TM), REMUNE(R) 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(TM), REMUNE(R) or IR103 might not prove to be effective as either a therapeutic vaccine, whether future trials will be conducted and whether the results of such trials will coincide with the results of NeuroVax(TM), REMUNE(R) or IR103 in preclinical trials and/or earlier clinical trials and the unresolved status of the Company's HIV program. 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's Annual Report on Form 10-K for the year ended December 31, 2006 will be filed soon and the set of risks set forth there should also be studied. 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(R) is a registered trademark of The Immune Response Corporation. NeuroVax(TM) is a trademark of The Immune Response Corporation.
MEDIA CONTACT:
Rachel Kessler
Chamberlain Communications Group Inc.
(212) 389-9155
rkessler@chamberlainpr.com
INVESTOR CONTACTS:
Robert Giordano
ROI Associates
(212) 495-0201
rgiordano@roiny.com
Gene Marbach
Makovsky & Company
(212) 508-9645
gmarbach@makovsky.com
COMPANY CONTACT:
Michael K. Green, COO
The Immune Response Corporation
(760) 431-7080
info@imnr.com
SOURCE The Immune Response Corporation
Texas Institute for Genomic Medicine Will Supply Myelin Repair Foundation with Knockout Research Mice Throughout North America
Apr 4 2007, 12:00 PM EST
Business Wire
The Texas Institute for Genomic Medicine (TIGM) has entered into an agreement with the Myelin Repair Foundation to supply up to 15 pair of genetically altered mice over the next 12 months for collaborative research in the U.S. and Canada to find the cause and possible treatments for multiple sclerosis (MS).
The Myelin Repair Foundation (MRF) is a non-profit organization focused exclusively on discovering how myelin, the protective insulation surrounding nerve fibers of the central nervous system, is created, damaged and can be repaired. The MRF, headquartered in Saratoga, California, has established an accelerated research collaboration process to bring together leading neuroscientists from a number of universities throughout North America to identify, understand and validate promising solutions more quickly. Traditionally, academic research data isn't shared until experiments are completed and results are published. Through its unique collaborative process, the MRF is breaking down academic silo barriers to encourage the sharing of data and insights while experiments are ongoing. In doing so, the MRF hopes to bring treatments for MS and other neurological diseases to the public on a more rapid timeline.
Under the terms of the agreement, TIGM will create custom-designed breeding pairs of knockout mice that have specific genes altered especially for the myelin research that scientists are conducting at five different locations over the next year.
"As a leading provider of genetically engineered knockout mice, TIGM provides an essential resource to academic and nonprofit researchers more quickly and cost effectively than alternate sources. By getting knockout mice into the hands of MRF researchers at an accelerated pace, TIGM can support MRF in their race to find breakthrough cures for MS," said Dr. Richard H. Finnell, TIGM executive director.
"TIGM has unique technology to produce the knockout mice we need far more efficiently than we could do it in our own labs," said MRF's Chief Operating Officer Rusty Bromley. "Our choice to align with organizations like TIGM for such specialized services is central to our model for speeding the discovery of drug targets."
About the Texas Institute for Genomic Medicine (TIGM)
TIGM is a not-for-profit institution created in 2005 to pioneer the development of life-changing medical breakthroughs, accelerate the pace of medical discoveries and to foster the development of the biotechnology industry in Texas. To that end, TIGM helps researchers worldwide gain faster, more cost-effective access to the genetically engineered knockout mice or mouse embryonic stem cells they need to help speed research to find the cure for human diseases and conditions. TIGM maintains the world's largest catalogue of more than 200,000 embryonic stem cells for C57BL/6 mice. In addition, TIGM has contracted access to the world's largest catalog of genetically modified 129 mouse cells, with more than 272,000 stem cell clones available. The Institute headquarters and laboratory facilities are based in the Texas Medical Center in Houston, Texas, with additional facilities currently under construction in College Station, Texas. For more information, log on to www.tigm.org or call 888-377-TIGM (toll free in North America).
About the Myelin Repair Foundation
The Myelin Repair Foundation (MRF) - www.myelinrepair.org - is a non-profit medical research foundation dedicated to accelerating basic medical research and its translation into myelin repair treatments that will dramatically improve the lives of people suffering from multiple sclerosis (MS). Many believe MRF's Accelerated Research Collaboration(TM) model could change the way in which all medical research is done.
Tuesday, April 03, 2007
New Mexico approves medical use of marijuana
Mon Apr 2, 2007 7:22PM EDT
ALBUQUERQUE, New Mexico (Reuters) - New Mexico doctors are allowed to prescribe marijuana to help some seriously ill patients manage symptoms including pain and nausea under a bill signed into law by Gov. Bill Richardson on Monday.
"This law will provide much-needed relief for New Mexicans suffering from debilitating diseases," Richardson said at the signing ceremony. "It is the right thing to do."
The southwestern state is the 12th in the United States to endorse the use of marijuana for medical uses. New Mexico's state legislature is the fourth in the country to enact such a measure.
The law allows marijuana use by patients suffering from several conditions, such as HIV/AIDS, cancer, glaucoma, and multiple sclerosis and epilepsy, according to a news release from Richardson's office.
Californians voted to allow use of medical marijuana in 1996. In 1978, New Mexico began allowing very limited use of marijuana, or its active ingredient, THC, to help control cancer patients' nausea and vomiting caused by chemotherapy, but only when other nausea-control drugs failed.
The law creates a panel of eight expert physicians and other health care workers to supervise the program. Qualified patients must be under a doctor's care and supervision, the news release said.
"I would like to thank the governor for ... giving me another shot at life," said Essie DeBone, who suffers from advanced complications from HIV/AIDS.
© Reuters 2007. All rights reserved.
Tysabri - new option for multiple sclerosis
02-Apr-07
Biogen Idec has launched Tysabri (natalizumab) as single disease modifying therapy in highly active relapsing-remitting multiple sclerosis for patients with high disease activity, despite treatment with interferon beta. It is also licensed for the treatment of patients with rapidly evolving severe relapsing-remitting multiple sclerosis.
PHARMACOLOGY
Natalizumab is a monoclonal antibody thought to act by inhibiting the migration of leukocytes into the central nervous system leading to a reduction of inflammation and demyelination.
CLINICAL STUDIES
The efficacy of natalizumab monotherapy was assessed in a two-year study1 involving 942 patients with relapsing multiple sclerosis who had experienced at least one clinical relapse in the previous 12 months and scored between 0 and 5 on the Kurtzke Expanded Disability Status Scale (EDSS).
Patients received treatment by intravenous infusion every four weeks for more than two years; 627 patients were randomly assigned to the natalizumab group (300mg) and 315 to the placebo group. The study evaluated the rate of clinical relapse at one and two years and the rate of sustained progression of disability, using EDSS, at two years.
After two years of treatment there was a relative risk reduction in the rate of relapse of 68 per cent for patients treated with natalizumab compared to placebo. The risk of sustained disability progression (for 24 weeks) was reduced by 54 per cent in patients treated with natalizumab compared to placebo.2 Natalizumab also showed significant effects on secondary end points, including a 92 per cent reduction in gadolinium enhancing lesions.
Overall adverse events were similar between the placebo and treatment groups. However, fatigue and allergic reactions were significantly more common with natalizumab compared to placebo.
1. Polman C, Paul M, O'Connor W et al. A randomised, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. NEJM 2006: Vol 354(9); 899–910.
2. Tysabri Summary of Product Characteristics. Biogen Idec Nov 2007.
Further information: Biogen Idec 01628 501000
New Mexico Medical Marijuana Law Sets Stage for Drive in Congress
Presidential Candidate Richardson Signs 12th Medical Marijuana Law
WASHINGTON, D.C. — Today's signing of the nation's 12th state medical marijuana law by New Mexico Gov. Bill Richardson (D) will jump-start efforts to reform federal policy on medical marijuana, advocates said today. The signing comes in the wake of new research further documenting marijuana's medical value.
New Mexico now joins Alaska, California, Colorado, Hawaii, Maine, Montana, Nevada, Oregon, Rhode Island, Vermont and Washington in protecting medical marijuana patients from arrest. Richardson, a candidate for the Democratic presidential nomination, actively lobbied for the bill's passage.
"Governor Richardson's action is the clearest sign yet that the politicians are finally catching up with the people on the issue of medical marijuana," said Aaron Houston, director of government relations for the Marijuana Policy Project (MPP) in Washington, D.C. "Support for medical marijuana is overwhelming — 78 percent in a national Gallup poll — and backing from the medical community is solidifying as new research continues to document marijuana's medical benefits. Support in Congress keeps growing, and this could be the year the federal government finally ends its cruel attacks on the sick in states where medical marijuana is legal."
MPP is working closely with other organizations and supportive members of Congress to pass an amendment to end federal medical marijuana raids in states with medical marijuana laws. Former Republican Congressman Bob Barr of Georgia recently joined MPP's lobbying effort.
A University of California study published in the Feb. 13 issue of the journal Neurology found that marijuana effectively relieved a type of severe nerve pain that afflicts hundreds of thousands with HIV/AIDS, and is similar to the type of pain experienced by many patients suffering from multiple sclerosis, diabetes, and other illnesses. A wide variety of medical and health organizations support legal access to medical marijuana, including the American Public Health Association, American Nurses Association, American Academy of HIV Medicine, and Lymphoma Foundation of America.
With more than 21,000 members and 100,000 e-mail subscribers nationwide, the Marijuana Policy Project is the largest marijuana policy reform organization in the United States. MPP believes that the best way to minimize the harm associated with marijuana is to regulate marijuana in a manner similar to alcohol. For more information, please visit www.MarijuanaPolicy.org.
Date: 4/2/2007
Opexa Therapeutics Reports Positive Top-line Data in Phase I/II Dose Escalation Trial with TovaxinTM for Multiple Sclerosis
Opexa Therapeutics Reports Positive Top-line Data in Phase I/II Dose Escalation Trial with TovaxinTM for Multiple Sclerosis
THE WOODLANDS, Texas--(BUSINESS WIRE)--Opexa Therapeutics, Inc. (NASDAQ: OPXA), a company involved in the development and commercialization of cell therapies, today announced positive top-line data in an open-label Phase I/II dose escalation clinical trial of the investigational T-cell vaccine, Tovaxin™, for multiple sclerosis. In this one-year, 10-subject dose escalation clinical trial, Tovaxin therapy was shown to be safe and effective. The “per-protocol” analysis of Tovaxin therapy achieved a 90% reduction (p = 0.0039) in annualized relapse rate (ARR) in subjects who received one of the three dosage levels; the doses were 6 – 9 x 106, 30 – 45 x 106 or 60 – 90 x 106 attenuated T-cells. Subjects in the study received subcutaneous injections of Tovaxin over a period of 20 weeks (0, 4, 12 and 20 weeks) and were monitored for an additional 32 weeks.
The safety profile for all dosage levels revealed no severe adverse reactions related to T-cell vaccination. With increasing dosage, an increase in mild injection site reactions was observed and these resolved within 48 hours.
All subjects currently are enrolled in an extension study to collect longitudinal safety and effectiveness data.
David McWilliams, president and chief executive officer of Opexa, commented, “We are particularly encouraged by the data from this dose escalation trial. While all three dosage levels were safe and effective, the group treated with the 30 – 45 x 106 T-cell dose achieved a 100% reduction in ARR. The currently enrolling Tovaxin IIb clinical trial is being conducted with the 30 – 45 x 106 T-cell dose.”
About TERMS
The Tovaxin Phase IIb clinical study will include 150 patients in a multicenter, randomized, double blind, placebo-controlled trial designed primarily to evaluate the efficacy, safety and tolerability of the Tovaxin T- cell vaccination with clinically isolated syndrome (CIS) and relapsing-remitting MS (RR-MS) patients. A total of 100 patients will receive Tovaxin, while 50 will receive placebo. The study is designed as a two-arm, 52-week, parallel-group study, whereby patients will be given five subcutaneous injections at 0, 4, 8, 12 and 24 weeks. The analyses will be performed at the end of the 52-week study to assess the safety and efficacy of Tovaxin. The primary efficacy variable is the cumulative number of gadolinium-enhancing lesions on T1-weighted MRI scans summed over the Week 28, 36, 44, and 52 MRIs. The secondary efficacy variables are the cumulative number of new gadolinium-enhancing lesions at Weeks 28-52, the change in T2-weighted lesion volume, and the annualized relapse rate. As of March 19, 2007, Opexa reported that more than 110 patients have been enrolled in the TERMS clinical trial and the Company expects enrollment to be complete by mid 2007.
All patients who complete the trial will be eligible to participate in an optional one-year extension study, in which they will receive Tovaxin under an open-label protocol. The open-label study is being planned under a different protocol that will be submitted to the FDA.
The TERMS study is being conducted at 36 U.S. sites to evaluate the safety and effectiveness of Tovaxin It is registered on the U.S. National Institutes of Health-sponsored website, www.clinicaltrials.gov, where pharmaceutical companies are required to register trials for medicines that will treat serious or life-threatening diseases or conditions. For more information, visit the TERMS website at www.tovaxin.com.
About T-cell Vaccination
For a T-cell vaccine to be effective, it should be able to induce T-cell cytotoxic and/or regulatory immune responses against the pathogenic T-cells. Studies of T-cell vaccine have indicated that T-cell vaccination with peripheral blood-derived autologous myelin-peptide selected T-cells in multiple sclerosis patients resulted in the in vivo induction of CD8+ cytotoxic T-cells and CD4+CD25+FoxP3 Tregs specific for T-cell vaccine. The induction of anti-idiotypic cytotoxic CD8+ effector T-cells and anti-ergotypic CD4+CD25+FoxP3 positive Tregs is believed to provide a therapeutically effective dual mechanism of protection to patients treated with Tovaxin™. The observed regulatory immune responses have been shown to collectively correlate with clinical improvement in treated patients.
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. For more information, visit the Opexa Therapeutics website at www.opexatherapeutics.com.
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.
Editor's Note:
In first and fourth paragraphs of this release, T-cell dosage levels include the figure 10(6), which should be read as ten to the sixth power.
Subscribe to:
Posts (Atom)