PRNewswire - October 31, 2000

"The Immune Response Corporation is an ardent supporter of publication of clinical trial data," said Ronald B. Moss, M.D., Vice President, Medical and Scientific Affairs of The Immune Response Corporation and Assistant Clinical Professor of Medicine, University of California San Diego School of Medicine. "The Company has a strong commitment to publishing clinical trial data. This year alone, we have 11 articles regarding various research with REMUNE that have been either published in or accepted by peer-reviewed scientific journals."

As was previously announced by the Company on May 17, 1999, Study 806, a 2500-patient, placebo-controlled Phase III clinical trial of REMUNE, was concluded based on the recommendation of an independent Data Safety Monitoring Board (DSMB). The trial was concluded because differences in clinical endpoints were not observed between treatment groups and because extending the trial would have been unlikely to provide sufficient additional clinical endpoints to permit statistically significant differences between treatment groups to be observed in the near term. Before the study began, the predicted clinical endpoint event rate was 6% progression per year, meaning that 6% of 2,500 patients would progress to an AIDS defining condition or death each year. However, when the study was stopped, only 0.73% per year progressed using the original Centers for Disease Control AIDS-defining conditions.

"What is at issue here is that while an effect of REMUNE on 'clinical' endpoints was not demonstrated in Study 806, we still gained very important insight from data concerning the effects of REMUNE on viral load (the amount of HIV in the bloodstream). This viral load information has helped us to design subsequent clinical trials of REMUNE," said Dr. Moss. "These data were presented to the other clinical trial investigators. We feel that there was a general consensus from the investigators that these data should be presented in detail in the manuscript."

Before Study 806 began, a substudy was planned to examine more closely the effects of REMUNE on immune responses and viral load. Data from a random, pre-selected subset of 252 patients suggested that viral load was significantly lower (p<0.05) at multiple timepoints (Weeks 36, 48, 60, 84, 96 and 120) in REMUNE treated patients compared to the control group. The reduction in virus correlated with the induction of cell-mediated responses (T cell help) against the virus. Dr. Moss gave an oral presentation on these subset data at the Royal College of Physicians in London, England, on November 3, 1999 (Company press release).

"In the subset study, we observed that patients treated with REMUNE had lower viral loads and increased T cell help compared to the placebo group. This is important because these characteristics are typical for people with HIV that do not progress in their disease," said Dr. Moss. "We had tried to come to an agreement with Dr. Kahn to publish all the data and to let the clinical investigators have a chance to review the manuscript. However, the authors decided to submit a manuscript to a scientific journal without input from their colleagues who participated in the study. We felt that involvement of a third party through arbitration was the only way to ensure that all parties, including the clinical trial investigators, would have input on what would be published."

"As the top patient-enrolling clinical investigator in Study 806, I am extremely disappointed that neither I nor the other investigators were given the opportunity to review the manuscript of this very important clinical trial before it was submitted for publication. This omission was particularly surprising given that I have worked with these authors on several projects in the past," said John L. Turner, M.D., at Graduate Hospital, Philadelphia, Pennsylvania. "The Company has informed me that the details of the virological substudy will not be included in the manuscript to be submitted for publication, and I find this to be an egregious omission."

Prompt notification of the ending of Study 806 was provided to the patients and the public. The investigational sites were informed within 24 hours of the Company's decision to end the trial in May 1999. With this notification, the clinical trial investigators were instructed to notify the study volunteers at their respective sites and schedule termination visits. In addition, the Company sponsored several meetings with the clinical investigators, including one at the conclusion of the trial in which Dr. Kahn, Dr. Stephen Lagakos, Professor of Biostatistics, School of Public Health, Harvard University and the Company presented complete data for review. This meeting was held in June 1999 and was attended by the majority of the clinical investigators or their designated representatives.

The public was informed of the results of Study 806 through wide dissemination of the Company press release dated May 17, 1999 and Company 8-Ks dated May 14 and 17, 1999 and filed with the Securities & Exchange Commission.

Before the beginning of the clinical trial, the Company entered into customary agreements with the study team, which included Dr. Kahn, as well as the other clinical investigators. These agreements provided for confidentiality of certain clinical data. When Dr. Kahn informed the Company of his intent to publish data from Study 806 without incorporating a pre-planned substudy analysis, which other clinical investigators and the Company deemed essential for completeness, this reinforced the Company's decision to enter into arbitration.

At the time Study 806 began, clinical endpoints were the only measures of efficacy that were accepted by the FDA for approval of REMUNE. Since then, the FDA now allows viral load markers for licensure of biological products such as REMUNE. A Phase III pivotal trial of REMUNE was initiated in September 1999 that is testing endpoints based on viral load instead of progression to AIDS and death (clinical endpoints).

NOTE: The Immune Response Corporation will conduct a conference call with the investment community and other interested parties at 4:00 p.m. ET (1:00 p.m. PT) on Wednesday, November 1, 2000. Interested parties can access this call at http://www.vcall.com. No access code is required to listen to the call. If you are not able to listen to the live call, a replay at http://www.vcall.com will be available for 90 days following the conference call.

The Immune Response Corporation is a biopharmaceutical company based in Carlsbad, California, developing immune-based therapies to induce specific immune responses for the treatment of HIV, autoimmune diseases and cancer. In addition, the Company is developing a targeted non-viral delivery technology for gene therapy, which is designed to enable the delivery of genes directly to the liver via intravenous injection.

This news release contains forward-looking statements. Actual results could vary materially from those expected due to a variety of risk factors, including, but not limited to, whether additional clinical trials will be successfully concluded and whether REMUNE will be approved for marketing or be successfully commercialized. Those factors are discussed more thoroughly in The Immune Response Corporation's SEC filings, including but not limited to its report on Form 10-K for the year ended December 31, 1999 and subsequent Forms 10-Q. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements which may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

REMUNE(TM) is a trademark of The Immune Response Corporation.

SOURCE The Immune Response Corporation Web Site: http://www.imnr.com Company News On Call: http://www.prnewswire.com/comp/434675.html or fax, 800-758-5804, ext. 434675
001031
PR0010

Always watch for outdated information. This article first appeared in 2000. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2000. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .