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The Immune Response Corporation Updates Business and Clinical Strategies on Investor Conference Call

Posted on: Monday, 19 September 2005, 18:00 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), held an investor conference call today to update investors on the regulatory strategy for initiation of a multi-center Phase III clinical trial for the Company's lead HIV product candidate, REMUNE(R), as well as the other clinical programs including MS.

"I truly believe we are on the verge of proving the value of our technologies to the scientific and health care communities. Our main focus is still advancing the HIV clinical program and we are continuing to see promising results with both REMUNE(R) and our new product, IR103," said John N. Bonfiglio, Ph.D., president and chief executive officer of The Immune Response Corporation. "NeuroVax(TM), our MS product candidate, continues to demonstrate promising results and we are currently seeking a partner to help us meet its potential."

HIV Clinical Program

The REMUNE(R) clinical program is progressing and continuing to collect data that will provide information useful to development of the large-scale Phase III clinical trial. Preliminary results from a Phase II study conducted in Spain were presented at the prestigious International AIDS Society meeting in Rio de Janeiro in July, and appear to show that long-term REMUNE(R) treatment was effective in delaying virologic failure during antiretroviral treatment interruption. Even more significant to the Company were the results of the recently completed Phase II study in Italy. This study demonstrated stabilization of CD4+ cell counts in drug-naive patients. The finding is important because it is the patient population in which the Company will focus its registration strategy and it corroborates data from other studies which have suggested that REMUNE(R) helps to maintain CD4+ cell counts in drug-naive individuals.

The Company has begun to implement its strategy of initiating a worldwide registration trial with REMUNE(R) by having useful and positive meetings with both the Canadian and British health authorities. Meetings with the Spanish and Italian authorities as well as the European Agency for the Evaluation of Medicinal Products, or EMEA, which regulates medicines across the EU are in development. The purpose of these meetings is to review the research data to date and invite input into the protocol for a multi-national, multi-center registration trial evaluating the safety and efficacy of REMUNE(R) in people living with HIV that have not been eligible to receive drug therapies. The Company anticipates that this Phase III clinical trial will start in mid-2006 and will continue for approximately three years. Feedback from these meetings will be used to set up a meeting with the US Food and Drug Administration (FDA) which is expected to occur within the next several months.

Simultaneous to pursuing a Phase III program for REMUNE(R), the Company is continuing its Phase I/II clinical program for its newest HIV product candidate, IR103. IR103 combines REMUNE(R) with a new state-of-the art adjuvant called Amplivax(TM) which is licensed from Idera Pharmaceuticals. Preliminary results from a Phase I/II IR103 clinical trial, presented at the International AIDS Society meeting in Rio de Janeiro in July, seem to indicate that the product is safe and induces HIV-specific immune responses similar to that in earlier preclinical studies. The Phase I/II trial is continuing and a second trial in Italy is schedule to begin shortly.

MS Clinical Program

NeuroVax(TM), the Company's immune-based product candidate for MS, offers a completely different approach to the treatment of MS. The product is designed to activate T-reg cells in a patient to control the disease. Early work has shown that patients exposed to NeuroVax(TM) have a strong immune response and previously published work demonstrates that these types of responses correlate to a clinical benefit. The Phase II clinical trial at Oregon Health Sciences University is ongoing and the Company is continuing to present data from this trial. Data from this trial was recently announced at the European Neurological Society in Vienna which demonstrated that monthly NeuroVax(TM) injections during a one-year period increased the FOXP3 marker and T-reg cell functional activity in MS patients to a level equivalent to that seen in healthy controls. It is believed that T-reg cells are associated with maintaining the immune system and, therefore, may be relevant in the regulation of autoimmune diseases such as MS. The latest NeuroVax(TM) data will be presented at the upcoming 21st Congress of the European Committee for Treatment and Research in Multiple Sclerosis, commonly called ECTRIMS.

"The Company is moving in very exciting and important directions," concluded Dr. Bonfiglio. "The HIV program is at a critical point which we believe will allow a move toward registration trials in a very short time frame. The MS program also increases awareness of The Immune Response Corporation in both the scientific and investor communities."

Conference Call Replay Information

A replay of the conference call will be available beginning at 6:30 PM Eastern Time, 3:30 PM Pacific Time on September 19, 2005. To listen to a replay of the conference call, dial 1-888-286-8010 (domestic callers) or 1-617-801-6888 (international callers) with a passcode of 63933716 or listen via the website. The replay will be available for one week.

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 registered trademark of Idera Pharmacuticals, Inc.

Source: Business Wire

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