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The Immune Response Corporation Presents the First Human Data With IR103 at the International AIDS Society Meeting in Rio; REMUNE(R) Data Also Presented in Drug-Naive HIV Positive Individuals

Posted on: Tuesday, 26 July 2005, 15:01 CDT

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 the first clinical trial data with IR103, the Company's newest immune-based therapy candidate, were presented as a late-breaker at today's sessions at the International AIDS Society (IAS) meeting in Rio de Janeiro, Brazil. In addition, an oral and poster presentation of data from a Phase II study conducted in Italy with REMUNE(R), the Company's lead HIV product candidate, was presented.

Preliminary results of the IR103 trial indicate the product is safe, induces HIV-specific immune responses and greatly enhances IFN-gamma and RANTES mRNA. IFN-gamma and RANTES are considered immune system markers that give an estimate of the robustness of the immune response generated by IR103 in patients. The REMUNE(R) data from the Italian trial were obtained in drug-naive HIV positive patients which is the same group the Company plans to examine in registration trials next year.

"We are encouraged that these early results from the first IR103 human trial confirm results previously obtained in animal studies, demonstrating enhancement of HIV-specific immune responses," said John N. Bonfiglio, Ph.D., President and Chief Executive Officer of The Immune Response Corporation. "The REMUNE(R) results presented today are another example of the advancement of that program and have been helpful as we design our Phase III registration trials for next year."

"This is the first time we are presenting data from our first IR103 human trial and we are excited to be able to do so at this prestigious forum," said Georgia Theofan, Ph.D., Vice President of Clinical Development at The Immune Response Corporation. "We feel especially proud that these results were selected to be a late-breaker at this important meeting."

Early safety data from 43 patients and preliminary immunology data from 14 patients in this ongoing clinical trial were included in the preliminary results presented today at IAS. IR103 was well tolerated and no related serious or grade IV adverse events were reported. Median changes from baseline at week 24 in IFN-gamma and RANTES mRNA demonstrated enhanced responses in the patient receiving the combination of REMUNE(R) and Amplivax(TM) at all doses. The effects of the combination were dose dependent with the maximum effect seen in patients treated with REMUNE(R) plus 1.0 mg of Amplivax(TM). Plasma IL-7 levels were also increased, but only in patients receiving the highest dose of Amplivax(TM).

About the IR103 Study

The current phase of the study presented today, which is still ongoing, is a 45-patient, five-arm, randomized, single-blind, controlled, multi-center Phase I/II study that commenced enrollment in 2004 and will run for approximately 28 weeks after the last patient is enrolled. The primary objective of this study is to evaluate safety and bioactivity, or the ability to generate HIV-specific immune responses, to various doses of IR103, a therapeutic HIV vaccine consisting of a whole-killed HIV-1 antigen combined with an immunostimulatory oligonucleotide adjuvant (Amplivax(TM)), in HIV patients on HAART (highly active antiretroviral therapy). Evaluation of IR103 in antiretroviral-naive patients is also in progress. Ability to generate HIV-1 specific immune responses is thought to be an important indicator of clinical utility.

Amplivax(TM) was developed by Hybridon, Inc. and has been licensed to The Immune Response Corporation.

About the Italian Study

The multi-center, single-blind, randomized study followed 51 patients over 28 weeks following treatment with REMUNE(R), IFA or saline. Patients were antiretroviral naive and had HIV RNA levels between 10,000 and 40,000 copies/mL and CD4+ counts between 400 and 800 cells/microliter at study entry. Patients received three injections of REMUNE(R) (n=19), IFA (n=10), or saline (n=11) at weeks 0, 12, and 24. A fourth group received only a single injection of REMUNE(R) at week 0 (n = 11). Topline data from this study was included in a press release earlier this year.

The final analysis included data from 51 patients enrolled in the study, and showed that median absolute CD4+ cell counts remained stable through week 28 in the patients that received 3 injections of REMUNE(R), but declined in both the IFA and saline groups. REMUNE(R)'s effect on immune reconstitution as further evidenced by an augmented serum concentration of IL-7 and increases in naive CD4+ T-cells suggests a possible mode of action via stimulation of thymus function. The researchers believe that this effect on the thymus may be important in boosting the body's own defense against HIV. Further research is being carried out to confirm this positive effect on thymus and the circulating lymphocytes phenotypes.

Both trials were intended to explore the potential utility of REMUNE(R) and IR103, and neither trial was 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 these two trials 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.

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

Source: Business Wire

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