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The Immune Response Corporation Cleared to Initiate New IR103 Study in HIV Drug-Naïve Patients in Italy


IR103 Clinical Program Expands to 9 Sites in 3 Countries.

Carlsbad, California – September 27, 2005 -- 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 today it will begin enrolling patients in Italy in a Phase I/II study investigating IR103, the Company’s newest product candidate for the treatment of HIV.

“The protocol for this study is designed to be compatible with part of the Phase I/II clinical trial currently underway in Canada and the UK so that the data can be jointly analyzed,” said Georgia Theofan, Ph.D, vice president of clinical development at The Immune Response Corporation. “We are excited to be adding these six new sites to the IR103 clinical program which will now be active at nine sites in three countries.”

The randomized, double-blind, comparative, multi-center Phase I/II study will begin enrolling patients this year and will follow them for 52 weeks. The primary objective is to evaluate safety and bioactivity, or the ability to generate HIV-specific immune responses to IR103, in HIV patients who have not initiated highly active anti-retroviral therapy (HAART). Ability to generate HIV-specific immune responses is thought to be an important indicator of clinical utility.

The patients, up to a total of 100, will be either newly enrolling patients or will be returning patients from a previous Remune® study. Patients previously treated with Remune® will be assigned across both tracks of the study enabling analysis of IR103 and Remune® in this patient population. The IR103 study track will evaluate and compare response to varying doses as well as placebo.

“Our strategies for Remune® and IR103 are complimentary with our drive to move Remune® into Phase III trials next year and IR103 continuing in Phase I/II. Both products are being investigated in HIV-positive, drug-naïve patients and we believe they may be effective therapies throughout disease progression,” remarked John N. Bonfiglio, Ph.D., president and chief executive officer of The Immune Response Corporation.

Remune® and IR103 are in clinical development by The Immune Response Corporation and are not approved by any regulatory agencies in any country at this time. IR103 combines the Company’s patented HIV-1 immunogen with Amplivax™, an immunostimulatory oligonucleotide adjuvant. Amplivax™ was developed by Idera Pharmaceuticals and has been licensed to The Immune Response Corporation.

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®, 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, Italy, and the United Kingdom.

The Immune Response Corporation is also developing an immune-based therapy for MS, NeuroVax™, 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

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®, NeuroVax™ 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®, NeuroVax™ 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®, NeuroVax™ 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® is a registered trademark of The Immune Response Corporation. NeuroVaxTM is a trademark of The Immune Response Corporation. Amplivax™ is a trademark of Idera Pharmaceuticals, Inc.


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