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The Immune Response Corporation Presents REMUNE® Data at the International AIDS Society Meeting in Rio; Results from Spanish Trial Presented in Two Posters
Business Wire, July 27, 2005
CARLSBAD, Calif. -- 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 that results from a Phase II trial with REMUNE(R), conducted in Spain, were presented in two posters at today's sessions at the International AIDS Society (IAS) meeting in Rio de Janeiro, Brazil.
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The first poster presented results from the recently completed extension of the Phase II study, known as REMIT, which showed that treatment with REMUNE(R) was effective in delaying virologic failure during antiretroviral treatment interruption. Patients receiving the greatest number of injections showed the longest time to reach a failure endpoint. This study also showed a correlation to the magnitude of HIV-specific immune responses induced in studied patients. Long-term vaccination with REMUNE(R) may enhance host HIV-1 specific CD4+ and CD8+ T-cell responses and result in a better control of plasma viral load after antiviral therapy withdrawal.
The second poster presented results obtained in a subset of patients from the original Spanish Phase II study (STIR-2102), and demonstrated that in addition to induction of HIV-1 specific immune responses previously described, therapeutic vaccination with REMUNE(R) also resulted in induction of allo-specific responses. Following 24 months of treatment, anti-HLA antibodies were present in 25/34 (74%) of REMUNE(R)-treated patients, but only in 8/32 (25%) of patients treated with Incomplete Freud's Adjuvant (IFA) as a placebo. Development of anti-HLA antibodies was correlated with increases in HIV-specific T-cell proliferation in the REMUNE(R) group.
The importance of allo-specific responses, as shown in this subset study, has been recently highlighted by the suggestion that immunization against HLA alloantigens could be a strategy for developing an AIDS vaccine. Allo-responses could be useful in strategies of therapeutic vaccination against HIV infection.
About the REMIT Study
The REMIT study enrolled 39 patients who had previously participated in the STIR-2102 Phase II double-blind study in Spain (Vaccine 2004; 22: 2966-73) in which they received either REMUNE(R) or IFA, and then subsequently received REMUNE(R) in an open-label extension. For the REMIT study, the patients were randomized to receive either REMUNE(R) (n = 21) or IFA placebo (n= 18) at the time of discontinuation of highly active antiretroviral therapy (HAART). Endpoints in the 48-week study measured immunologic or virologic failure of patients during treatment interruption, defined as time to reach HIV RNA viral load failure (defined as HIV RNA greater than 55,000 copies/mL), time to reach CD4+ failure (as defined as less than 350 cells/mL), and/or time to re-initiation of HAART.
The trial was intended to explore the potential utility of REMUNE(R) and was not designed to have enough statistical power to be used for regulatory approval. The Company is planning a clinical program that would use the data from this trial to design registration trials in the near future.
REMUNE(R) is in Phase II development by The Immune Response Corporation and is not approved by any regulatory agencies in any country at this time.
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.
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