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The Immune Response Corporation Presents Preliminary Analysis of REMUNE Phase II Trial in HIV Positive, Drug Naive Patients

Posted on: Wednesday, 17 November 2004, 12:00 CST

CARLSBAD, Calif., Nov. 17 /PRNewswire-FirstCall/ -- The Immune Response Corporation , a biopharmaceutical company dedicated to becoming a leading immune-based therapy company in HIV and multiple sclerosis, presented preliminary data this week from an ongoing Italian Phase II study of REMUNE(R) treatment in HIV positive, antiretroviral-naive patients at the 7th International Congress on Drug Therapy in HIV Infection meeting in Glasgow, Scotland.

The analysis included data from 37 patients out of a total of 51 patients enrolled in the study. In the group of patients who received three injections of REMUNE(R) over the 28-week study period, several positive trends were observed in key markers believed to indicate immune responses against HIV disease, including trends toward stabilization of total CD4+ T-cell counts, increased HIV-specific CD8+ memory T-cells, and decreased levels of activated CD38+ T-cells, following REMUNE(R) treatment. The final analysis of this study is expected by the end of the year.

"At first look, these data suggest that REMUNE(R) may be improving immune response against HIV in these drug-naive patients. Further studies are required to confirm if such responses can be sustained and result in clinical benefit to patients who do not yet meet the criteria for initiation of antiretroviral therapy," commented Mario Clerici, M.D., lead immunologist for the study and Chair of Immunology at the University of Milan, Italy.

"We are encouraged by this data and, as a result, will expand our research in HIV-naive patients," said Georgia Theofan, Ph.D., Vice President of Clinical Development at The Immune Response Corporation. "We will begin a rollover study to expand the data on REMUNE(R) and to test our newest HIV product candidate, IR103 in this patient population."

The multi-center, single-blind, randomized study followed 51 patients over 28 weeks following treatment with REMUNE(R), Incomplete Freud's Adjuvant (IFA) or saline. The study had two patient groups treated with either one or three injections of REMUNE(R) and each of the other arms received three injections of either IFA or saline. The four arms of the study each received injections at weeks 0, 12 and 24. A rollover study to REMUNE(R) and IR103 is planned.

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. Professor Clerici has served as a research investigator for The Immune Response Corporation and has received research funding support from the Company.

About The Immune Response Corporation

The Immune Response Corporation is a biopharmaceutical company dedicated to becoming a leading immune-based therapy company in HIV and multiple sclerosis (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 and has shown potential therapeutic value for this difficult-to-treat disease.

Please visit The Immune Response Corporation at http://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, 2003, and its subsequent Quarterly Reports 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.

MEDIA CONTACT: INVESTOR CONTACT:

Laura Silver Michael K. Green

Sam Brown Inc. Corporate Communication Chief Financial Officer

310-551-9940 760-431-7080

silver@sambrown.com info@imnr.com

The Immune Response Corporation

CONTACT: Laura Silver of Sam Brown Inc. Corporate Communication,+1-310-551-9940, silver@sambrown.com; or Michael K. Green, Chief FinancialOfficer of The Immune Response Corporation, +1-760-431-7080, info@imnr.com

Web site: http://www.imnr.com/

Source: PRNewswire-FirstCall

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