PS Where has my workmate Dignan gone? Good to see that Dunmann is taking up the slack. This time next week I will be in Mauritius so I'll be expecting Dignan to start getting his hands dirty again.
Prestigious Board to Guide Research and Development of NeuroVax(TM)
March 29, 2006--The Immune Response Corporation announced today that it has formed a Scientific Advisory Board to provide scientific and clinical direction in its development of NeuroVax(TM), its therapeutic product candidate for the treatment of multiple sclerosis (MS).
"We are honored to have six of the leading minds in MS research working with us to guide the development of NeuroVax(TM)," said Dr. Joseph O'Neill, Chief Executive Officer and President of The Immune Response Corporation. "Our clinical findings indicate that NeuroVax(TM) induces strong, disease-specific immune responses in essentially all the MS patients treated. We are eager to continue with additional Phase II studies and will launch a 300-patient trial later this year in Eastern Europe and the United States that will test the clinical benefit of NeuroVax(TM) by assessing its effect on MRI and relapse rates."
New data indicates that an important part of the strong disease-specific immune response induced by NeuroVax(TM) is the stimulation of FOXP3+ Regulatory T-cells. This exciting approach could play an important role in the treatment of MS and other autoimmune diseases, such as rheumatoid arthritis, psoriasis and Crohn's disease.
The Scientific Advisory Board guiding the development of NeuroVax(TM) will consist of six members:
Dr. Jack Antel is a professor in the Department of Neurology and Neurosurgery at McGill University. He is Co-Director of the Neuroinflammation Training Program sponsored by the Canadian Institute of Health Research (CIHR). In 2005, Dr. Antel received the National MS Society/American Academy of Neurology John Dystel Prize for MS Research. He is also an associate member of McGill's Department of Microbiology and Immunology and Coordinator of the MS Program at the Montreal Neurologic Institute.
Dr. Dennis Bourdette is the Director of the MS Center of Oregon and Chair for the Department of Neurology at Oregon Health and Science University (OHSU), where he has been a faculty member since 1983. He is also a staff neurologist at the Portland Veterans Affairs Medical Center. Dr. Bourdette has published numerous articles on MS and is listed in the Best Doctors in America.
Professor Giancarlo Comi is the Director of the Department of Neurology and Clinical Neurophysiology at San Raffaele Hospital in Milan, Italy. He is a professor of Neurology at the University Vita-Salute San Raffaele and has chaired its graduate school in neurology since 2001. His fields of interest are the study of the natural history, research and validation of new therapies in MS. Professor Comi has authored or co-authored more than 400 articles in peer-reviewed journals and edited six books.
Professor Krzysztof W. Selmaj is the Chairman of the Department of Neurology at the Medical University in Lodz, Poland, and serves as the Chairman of the European Federation of Neurology. He has received several honors and awards, including the Polish Academy of Science Sniadecki Award and the Polish Science Foundation Award. Professor Selmaj has authored numerous articles about neurology and MS and is on the editorial boards of the Journal of Neuroimmunology and European Journal of Neurology.
Dr. Arthur Vandenbark is a senior research career scientist at the Portland Veterans Affairs Medical Center, and a professor in the Departments of Neurology and Molecular Microbiology and Immunology at OHSU. An inventor and pioneer of the TCR peptide vaccination approach for MS, Dr. Vandenbark is the recipient of the Javits Neuroscience Investigator Award. He has published numerous articles in the area of MS and its animal models.
Dr. Jerry S. Wolinsky directs the Multiple Sclerosis Research Group and the Magnetic Resonance Imaging Analysis Center at the Graduate School of Biomedical Sciences at the University of Texas Health Science Center at Houston. He chairs the Research Programs Advisory Committee of the National MS Society and is the Chair of the Americas Committee for Treatment and Research in MS. Dr. Wolinsky is an associate editor of ACP Medicine and on the editorial board of Multiple Sclerosis: Clinical and Laboratory Research. He is recognized in The Best Doctors in America and America's Top Doctors.
Forming a Scientific Advisory Board for NeuroVax(TM) is part of a new strategic initiative to leverage The Immune Response Corporation's core immune-based technology for autoimmune and infectious diseases. Specifically, this strategy will focus on the accelerated development of the Company's most promising immune-based therapies currently in clinical trials, NeuroVax(TM) for MS and IR103 for human immunodeficiency virus (HIV).
About Multiple Sclerosis
MS is an autoimmune disease in which the immune system mistakenly attacks normal tissues of the central nervous system. It afflicts approximately 400,000 people in the United States and more than 2.5 million worldwide (source: National MS Society). The disease is caused by activation of a specific subset of the patient's own white blood cells, pathogenic T-cells, which then attack a fatty tissue called myelin that surrounds and protects nerve fibers and creates scarring (sclerosis) that interferes with the normal transmission of nerve impulses. This damage, in turn, leads to a variety of chronic and highly individual and unpredictable neurological symptoms, ranging from movement and balance problems to vision impairment.
Autoimmune diseases such as MS may result from the failure of normal immune regulatory mechanisms to prevent proliferation of pathogenic T-cells. Specifically, Immune Response Corporation's research indicates that MS patients have diminished levels of FOXP3 message and protein expression levels in peripheral T-cells. This observation is the first to link a defect in functional peripheral immunoregulation to an established genetic marker, FOXP3, which previously has been shown to be involved in maintaining immune tolerance and repressing the development of autoimmune diseases such as MS.
About The Immune Response Corporation
The Immune Response Corporation is an immuno-pharmaceutical company focused on developing products to treat autoimmune and infectious diseases. The Company's lead immune-based therapeutic product candidates are NeuroVax(TM) for the treatment of MS and IR103 for the treatment of HIV infection. Both of these therapies are in Phase II clinical development and are designed to stimulate pathogen-specific immune responses aimed at slowing or halting the rate of disease progression.
NeuroVax(TM), which is based on the Company's patented T-cell receptor (TCR) peptide technology, has shown potential clinical value in the treatment of relapsing forms of MS. NeuroVax(TM) has been shown to stimulate strong, disease-specific, cell-mediated immunity in nearly all patients treated and appears to work by enhancing levels of FOXP3+ Treg cells that are able to down regulate the activity of pathogenic T-cells that cause MS. Increasing scientific findings have associated diminished levels of FOXP3+ Treg cell responses with the pathogenesis and progression of MS and other autoimmune diseases such as rheumatoid arthritis (RA), psoriasis and Crohn's disease. In addition to MS, the Company has open Investigational New Drug Applications (IND) with the FDA for clinical evaluation of TCR peptide-based immune-based therapies for RA and psoriasis.
IR103 is based on the Company's patented whole-inactivated virus technology, co-invented by Dr. Jonas Salk and indicated to be safe and immunogenic in extensive clinical studies of REMUNE®, the Company's first-generation HIV product candidate. IR103 is a more potent formulation that combines its whole-inactivated antigen with a synthetic Toll-like receptor (TLR-9) agonist to create enhanced HIV-specific immune responses. The Company is currently testing IR103 in two Phase II clinical studies as a first-line treatment for drug-naive, HIV-infected individuals not yet eligible for antiretroviral therapy according to current medical guidelines.
NeuroVax(TM) and IR103 are in clinical development by The Immune Response Corporation and are not approved by any regulatory agencies in any country at this time. Please visit The Immune Response Corporation at www.imnr.com for more information.
This news release contains forward-looking statements. Forward-looking statements are often signaled by forms of words such as "should," "could," "will," "might," "plan," "projection," "forecast," "expect," "guidance," "potential" and "developing."
Actual results could vary materially from those expected due to a variety of risk factors, including whether the Company will continue as a going concern and successfully raise proceeds from financing activities sufficient to fund operations and additional clinical trials of its product candidates, 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 its product candidates might not prove to be effective as either a therapeutic or preventive vaccine, whether future trials will be conducted, and whether the results of such trials will coincide with the results of its product candidates in preclinical trials and/or earlier clinical trials. A more extensive set of risks is set forth in The Immune Response Corporation's SEC filings, including, but not limited to, its Annual Report on Form 10-K for the year ended December 31, 2005. 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.
NeuroVax(TM) is a trademark of The Immune Response Corporation. REMUNE® is a registered trademark of The Immune Response Corporation.
Source: Immune Response Corporation
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