Wednesday February 27, 7:01 am Eastern
SOURCE: The Immune Response Corporation
CARLSBAD, Calif. - The Immune Response Corporation (Nasdaq: IMNR - news) announced today that an interim analysis by the Company of their Phase I/II clinical study of NeuroVax(TM) in Multiple Sclerosis ("MS") confirmed that the primary endpoint had been met (p=0.0004). The interim analysis of the primary endpoint was performed according to an a priori definition of responder. A total of 20 subjects were included in the interim analysis that compared responses to peptides in Incomplete Freund's Adjuvant ("IFA") (8 subjects), peptides in saline (8 subjects) and IFA alone (4 subjects). The group of subjects receiving intramuscular injections of peptides in IFA (NeuroVax(TM)) demonstrated a statistically significant response as compared to the group receiving intradermal injections of peptides in saline or the group receiving IFA alone. Based on these statistically significant results and after discussion with the principal investigator, Dennis Bourdette, M.D., Oregon Health Sciences University, the company plans to amend the trial protocol to allow all participants currently enrolled to receive NeuroVax(TM). The company plans to discuss these results with the FDA regarding the design of the next trial.
"This is an important milestone in the development of T cell receptor peptide therapy. We finally have early clinical study indications of a vaccine candidate that may boost natural regulatory T cells in most, if not all, of the patients. It is gratifying to observe just how vigorous the responses were in all of the patients injected with NeuroVax(TM). These results will allow us to potentially move forward much more quickly to design and conduct an efficacy trial," said Arthur Vandenbark, Ph.D., Portland VA Medical Center, co-inventor of the technology.
The Phase I/II study was designed as a multicenter, three arm randomized 24-week study examining the effect of T cell receptor ("TCR") peptides in treating individuals with MS. T cells specific for antigens in the central nervous system are thought by scientists to be involved in the auto-reactive immune response in MS patients, which may lead to over-expression of certain T cells particularly BV5S2, BV6S5 and/or BV13S1. The purpose of immunization was specific activation of regulatory T cells that are capable of down- regulating the over-expressed auto-reactive T cells. The objective of the study was to confirm the established safety profiles of both NeuroVax(TM) and the mixture of the three peptides in saline, assess the ability to increase anti-inflammatory immune responses and to determine the optimal formulation of TCR peptides by comparing them to an adjuvant alone group (IFA). One arm included a formulated mixture of three distinct peptides emulsified in IFA (NeuroVax(TM)), another arm included the same peptides formulated in saline, and both of these arms were compared to IFA alone. A total of 25 patients were to be enrolled in each of the peptide arms and 10 in the adjuvant control arm. The primary endpoint for this study was the frequency of patients responding immunologically to the BV5S2, BV6S5 and/or BV13S1 peptides. Immunological responsiveness was determined using a limiting dilution assay (LDA) to these three peptides.
The Immune Response Corporation is a biopharmaceutical company based in Carlsbad, California, developing immune-based therapies to induce specific T-cell responses for the treatment of HIV, autoimmune diseases and cancer. In addition, the Company is developing a targeted non-viral delivery technology for gene therapy, which is designed to enable the delivery of genes directly to the liver via intravenous injection. NOTE: Company information can also be located on the Internet Web site: http://www.imnr.com
This news release contains forward-looking statements. Actual results could vary materially from those expected due to a variety of risk factors, including, but not limited to, whether clinical trials will be successfully concluded and whether NeuroVax(TM) will be approved for marketing or be successfully commercialized. Those factors are discussed more thoroughly in The Immune Response Corporation's SEC filings, including but not limited to its report on Form 10-K for the year ended December 31, 2000 and subsequent Forms 10-Q. The Company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements, which may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
NeuroVax(TM) is a registered trademark of The Immune Response Corporation.
SOURCE: The Immune Response Corporation
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