The Immune Response Corporation Announces Financial Support from The Canadian HIV Trials Network for Phase I/Ii Study Of IR103 Business Wire
click here to return to Business Wire main menu
DonateNow





The Immune Response Corporation Announces Financial Support from The Canadian HIV Trials Network for Phase I/Ii Study Of IR103

Business Wire - November 11, 2004


CARLSBAD, Calif.--The Immune Response Corporation (Nasdaq:IMNR), a biopharmaceutical company dedicated to becoming a leading immune-based therapy company in HIV and multiple sclerosis, announced today that the Canadian HIV Trials Network (CTN) has approved the Company's IR103-111 study for support. The CTN Steering Committee approved the submission for support with a high rating in innovation, relevance and quality from its Scientific Review Committee and Community Advisory Committee. The CTN is a national peer-review organization which provides support and infrastructure for HIV clinical trials in Canada. The trial will now be able to add new immunologic sub-studies that will help the Company expand its knowledge of the profile of this new product candidate.

The IR103-111 trial, with active sites in the United Kingdom and Canada, is the first human experience with IR103, which combines the Company's patented HIV-1 Immunogen with Amplivax(TM), an immunostimulatory oligonucleotide adjuvant. Animal studies presented this year using IR103 have shown an enhanced immune response that may be important in treating HIV-infected individuals.

"We are pleased to accept the support of the CTN, and that the CTN has approved our submission with such high rankings. This trial will now add additional immunological sub-studies which will increase our understanding of the clinical value of IR103," said John N. Bonfiglio Ph.D, Chief Executive Officer of The Immune Response Corporation. "This is an example of our strategy to seek scientific review and public support for important product candidates, both in the HIV and MS areas. We expect to continue this strategy over the next several years."

"The CTN scientific review and approval reinforces the importance of this trial, its potential, and underlines the need for a therapeutic HIV vaccine, which may help a person's immune system control HIV infection, potentially without the use of other medications. The potential for this trial to significantly improve the quantity and quality of HIV-specific immune responses is unique, due to the new combination of a vaccine derived from a whole-killed virus, and a powerful immune stimulator in patients with well-treated HIV infection," concluded Dr. Bill Cameron, Canadian principle investigator for the IR103-111 trial and Professor of Medicine, Division of Infectious Diseases, University of Ottawa at The Ottawa Hospital. "We have already begun enrolling patient-volunteers in this study, and are greatly looking forward to the results of this research."

The two-part, nine-arm, randomized, single-blind, controlled, multi-center Phase I/II study began this summer and will run for approximately 28 weeks with 80 patients enrolled. The primary objective of this study is to evaluate safety and bioactivity, or the ability to generate high levels of important and effective HIV-specific immune responses to IR103, with or without Incomplete Freund's Adjuvant (IFA), in HIV patients treated on HAART (highly active anti-retroviral therapy). The ability to generate high levels of specific immune responses is thought to be an important indicator of clinical utility.

IR103 is in Phase I/II development by The Immune Response Corporation and is not approved by any regulatory agencies in any country at this time. Amplivax(TM) was developed by Hybridon, Inc. and has been licensed to The Immune Response Corporation.

About The Canadian HIV Trials Network

The Canadian HIV Trials Network (CTN) is a partnership committed to developing treatments, vaccines and a cure for HIV disease and AIDS, through the conduct of scientifically sound and ethical clinical trials. CTN is committed to the pursuits of scientific excellence and ethical integrity in all undertakings. CTN is also dedicated to working in partnership with the international and national pharmaceutical industry, people living with HIV/AIDS, researchers and physicians. Please visit the CTN website at www.hivnet.ubc.ca for more information.

About The Ottawa Hospital

The Ottawa Hospital is a multi-campus academic health sciences center. With over 1000 beds, 10,000 staff plus 1,200 physicians, and an annual operating budget of approximately C$600 million, it is one of the largest healthcare organizations in Canada. In collaboration with the Ottawa Health Research Institute and the University of Ottawa, the Hospital is dedicated to excellence in patient care, to the education of future healthcare professionals, and to research resulting in bench-to-bedside discoveries. The Ottawa Hospital partners with various organizations to provide comprehensive, high quality, patient-focused healthcare services, in English and French, to over 1.5 million residents of eastern Ontario, and specialized and complex services for residents of northeastern Ontario. Please visit the Ottawa Hospital website at www.ottawahospital.on.ca for more information.

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 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 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.

CONTACT: The Immune Response Corp. (Investors)

Michael K. Green, 760-431-7080

info@imnr.com

or

Sam Brown Inc. Corporate Communication (Media)

Laura Silver, 310-551-9940

silver@sambrown.com

SOURCE: The Immune Response Corporation


041111
BW041105


Copyright © 2004 - Business Wire. All rights reserved. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Business Wire, Permissions Desk, Business Wire, 1185 Avenue of the Americas, 3rd Floor, New York, NY 10036; Tel: (212) 575-8822; FAX: (212) 575-1854. http://www.businesswire.com.

AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Broadway Cares/Equity Fights AIDS, Elton John AIDS Foundation, the National Library of Medicine, Pacific Life Foundation and donations from users like you.

Always watch for outdated information. This article first appeared in 2004. 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, 2004. 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. .