• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

The Immune Response Corporation's NeuroVax Demonstrates Increase in FOXP3 Gene Marker Levels and Treg Cell Functional Activity in MS Patients to Levels Similar to Human Controls

Posted on: Tuesday, 21 June 2005, 12:00 CDT

New One-Year Clinical Data Presented at European Neurological Association

The Immune Response Corporation (Nasdaq:IMNR), a biopharmaceutical company dedicated to becoming a leading immune-based therapy company in HIV and multiple sclerosis (MS), announced today that results from an ongoing clinical study demonstrated its investigational T-cell receptor (TCR) peptide vaccine, NeuroVax(TM), stimulated a significant increase in FOXP3, a gene marker recently shown to track regulatory T-cells (Treg cells). The new data, presented yesterday at the European Neurological Society (ENS) in Vienna, demonstrated that monthly NeuroVax(TM) injections during a one-year period increased the FOXP3 marker and Treg cell functional activity in MS patients to a level equivalent to that seen in healthy controls. Recently published research indicates that FOXP3, known to be associated with maintaining immune tolerance and regulation of autoimmune diseases, is significantly reduced in patients with MS compared to healthy controls.

"These preliminary results are an important indication that NeuroVax(TM) can restore Treg cell activity that may help reestablish regulatory control of pathogenic inflammatory T-cells," said Arthur A. Vandenbark, Ph.D., Senior Research Career Scientist at the Portland Veterans Affairs Medical Center, and Professor of Neurology and Molecular Microbiology and Immunology at the School of Medicine at Oregon Health & Science University in Portland, Ore., presenter of this research at ENS. "Successful boosting of Treg cell activity may reduce the immune system attack on the myelin sheath that contributes to the MS disease progression."

The clinical research presented at ENS yesterday was conducted by the Company in association with Oregon Health & Science University (OHSU). The preliminary results were based on the nine NeuroVax(TM) treated patients who have completed the 52-week study. Patients were analyzed at baseline and at 52 weeks, and were compared to a group of gender and age-matched healthy controls.

Autoimmune diseases such as MS may result from the failure of tolerance mechanisms to prevent expansion of pathogenic inflammatory T-cells. Previous research indicated that MS patients have abnormalities in FOXP3 message and protein expression levels in peripheral Treg cells. This observation linked a defect in functional peripheral immunoregulation to an established genetic marker, FOXP3, previously shown to be associated with maintaining immune tolerance and preventing development of autoimmune diseases. Diminished FOXP3 levels indicate impaired immunoregulation by Treg cells that may contribute to MS. The Company believes that induction of these Treg cells is important to the mechanism of action for NeuroVax(TM). The new data presented at the conference directly indicates for the first time that treatment with NeuroVax(TM) does stimulate FOXP3 Treg cells.

About Multiple Sclerosis and NeuroVax(TM)

MS is an autoimmune disease in which the immune system, the body's principal defense against foreign substances such as bacteria, 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. Specifically, the disease results in damage to a fatty tissue called myelin that surrounds and protects nerve fibers, creating 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. The disease is largely caused by activation of a specific subset of the patient's own white blood cells, pathogenic T-cells, which then attack the myelin and are largely responsible for disease progression.

The Company postulates that an immune-based therapy containing TCR peptides with Incomplete Freund's Adjuvant (IFA) stimulates regulatory T-cells capable of suppressing these autoreactive pathogenic T-cells. NeuroVax(TM), which combines three TCR peptides with IFA, was designed to increase the likelihood of this immune correction. The Company also intends to search for a corporate partner to help take this program to commercialization.

About OHSU

Oregon Health & Science University, located in Portland, Ore., includes the schools of dentistry, medicine, nursing and science and engineering; OHSU Hospital and Doernbecher Children's Hospital; numerous primary care and specialty clinics; multiple research institutes; and several outreach and community service units.

About The Immune Response Corporation

The Immune Response Corporation (Nasdaq: IMNR) is a biopharmaceutical company dedicated to becoming a leading immune-based therapy company in HIV and MS. The Company's HIV products are based on its patented whole-killed virus technology, co-invented by Company founder Dr. Jonas Salk to stimulate HIV immune responses. REMUNE(R), currently in Phase II clinical trials, is being developed as a first-line treatment for people with early-stage HIV. We have initiated development of a new immune-based therapy, IR103, which incorporates a second-generation immunostimulatory oligonucleotide adjuvant and is currently in Phase I/II clinical trials in Canada and the United Kingdom.

The Immune Response Corporation is also developing an immune-based therapy for MS, NeuroVax(TM), which is currently in Phase II clinical trials and has shown potential therapeutic value for this difficult-to-treat disease.

Please visit The Immune Response Corporation at www.imnr.com

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 REMUNE(R), NeuroVax(TM) 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 REMUNE(R), NeuroVax(TM) or IR103 might not prove to be effective as either a therapeutic or preventive vaccine, whether future trials will be conducted and whether the results of such trials will coincide with the results of REMUNE(R), NeuroVax(TM) or IR103 in preclinical trials and/or earlier clinical trials. These risks, among others, are 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, 2004, and its subsequent Quarterly Reports filed on Form 10-Q. The Company undertakes no obligation to update the results of these forward-looking statements to reflect events or circumstances after today or to reflect the occurrence of unanticipated events.

REMUNE(R) is a registered trademark of The Immune Response Corporation. NeuroVax(TM) is a trademark of The Immune Response Corporation.

Source: Business Wire

More News in this Category