The Immune Response Corporation Presents Updated Interim NeuroVax™ Data at European MS Meeting
October 3, 2005
The Immune Response Corporation Presents Updated Interim NeuroVax™ Data at European MS Meeting
Carlsbad, California – October 3, 2005 -- 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 Friday, September 30, 2005, that NeuroVax™ restored normal levels of FOXP3 and regulatory T-cells (T-reg cells) as well as increased IL-10 secretion in MS patients in an ongoing Phase I/II clinical study. FOXP3, T-reg cells and IL-10 are known to play important roles in regulating the immune system and it is believed that affecting these cells may be one of the mechanisms of action of NeuroVax™, the Company’s investigational T-cell receptor (TCR) peptide vaccine for the treatment of MS. The data was presented at the 21st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Greece.
“The NeuroVax™ clinical program continues to show promising results and we believe this new data on IL-10 secretion provides another important step towards understanding the clinical utility of the product,” said John N. Bonfiglio, Ph.D., president and chief executive officer of The Immune Response Corporation. “Although only a small number of patients are included in the MRI analysis, the MRI data suggest that NeuroVax™ may decrease the hallmark brain lesions indicative of MS. This decrease in lesions leads us to believe that NeuroVax™ may have a clinical benefit for MS patients.”
The NeuroVax™ clinical research presented at ECTRIMS was conducted by the Company in association with Oregon Health & Science University (OHSU). NeuroVax™ demonstrated strong immune responses, as measured by limiting dilution assay (LDA), in a sub-group of six MS patients analyzed after 48 weeks of monthly injections. As a group, they had increased their FOXP3 regulatory T-cells to levels equal to those seen in healthy controls.
Data were also presented from a previous blinded, controlled trial showing that 12 patients with positive MRI lesions at baseline all responded immunologically to NeuroVax™. Additional MRI analyses showed a decrease in the percentage of patients with MRI scans showing positive lesions (40% at baseline vs. 25% at 24 weeks) as well as a two-fold reduction in the mean number of Gadolinium positive lesions. In contrast, 12 control patients with MRI scans showing positive lesions at baseline showed average increases of about two-fold in both parameters during the same 24-week period.
Also presented in the poster were preliminary results showing that NeuroVax™ strongly boosted IL-10 secretion in two MS patients. Two NeuroVax™ treated MS patients and two healthy controls were tested for production of six different cytokines via cultured PBMC supernatants. Results showed high levels of IL-10 production in both MS patients indicating that NeuroVax™ induced IL-10 production, while the IL-10 secretion in the healthy controls remained at background levels.
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 T-reg 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 T-reg cells that may contribute to MS. The Company believes that induction of these T-reg cells is important to the mechanism of action for NeuroVax™. The new data presented at the conference tends to indicate that treatment with NeuroVax™ does stimulate FOXP3 T-reg cells.
About Multiple Sclerosis and NeuroVax™
Multiple sclerosis (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™, which combines three TCR peptides with IFA, was designed to increase the likelihood of this immune correction. The Company is seeking a corporate partner to advance this program in development and commercialization.
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 inactivated virus technology, co-invented by Company founder Dr. Jonas Salk to stimulate HIV immune responses. Remune®, 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, Italy and the United Kingdom.
The Immune Response Corporation is also developing an immune-based therapy for MS, NeuroVaxTM, 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®, NeuroVaxTM 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®, NeuroVaxTM 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®, NeuroVaxTM 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® is a registered trademark of The Immune Response Corporation. NeuroVax™ is a trademark of The Immune Response Corporation.
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