Business Wire - June 26, 2003
The Immune Response Corporation today announced that it has initiated preparations to launch a Phase II trial of REMUNE(R) in Italy. The trial is designed to measure the immunological effects of REMUNE(R) in HIV infected patients who have never received antiretroviral drug therapy. Data from this trial is expected to be used to guide the development of future studies in this patient population, furthering The Immune Response Corporation's global development strategy.
"We have yet to study REMUNE(R)'s potential to reconstitute the HIV-specific immune response in antiretroviral naive patients," said Georgia Theofan, Ph.D., vice president of clinical development for The Immune Response Corporation. "We are eager to launch the study, given its potential significance for those struggling with the adverse side effects of antiretroviral therapy."
Because of the toxicities, compliance difficulties and drug resistance issues associated with the chronic use of antiretroviral drugs, the guidelines regarding the initiation of antiretroviral therapy have become more conservative, with the Department of Health and Human Services in February 2002 recommending the use of drug therapies for asymptomatic patients who are infected with HIV be postponed until later in the disease progression.
"We are seizing this window of opportunity to test immune-based therapies with the potential to boost a patient's immune system to fight HIV, enabling us to determine whether we can successfully defer the use of antiretroviral drugs," said Mario S. Clerici, M.D., professor and chair of Immunology, University of Milan, and a member of The Immune Response Corporation's Scientific Advisory Board.
Dr. Clerici will serve as the trial's lead immunologist, with Andrea Gori, M.D., of the University of Milan's Luigi Sacco Hospital, acting as principal investigator. The trial is scheduled to last 28 weeks and will enroll 50 participants at four treatment sites in Italy. Subjects eligible for enrollment in the study must be antiretroviral naive. They will be monitored for the development of HIV-specific immune responses, changes in CD4 cell count and changes in viral load throughout the randomized, controlled phase II trial.
About The Immune Response Corporation and REMUNE(R)
Co-founded by medical pioneer Dr. Jonas Salk and headquartered in Carlsbad, California, The Immune Response Corporation is a biopharmaceutical company dedicated to treating HIV and AIDS through the development of REMUNE(R). REMUNE(R) is an immune-based therapeutic vaccine designed to induce an HIV-specific immune response and boost the body's natural defense mechanisms in order to slow the virus' progression. REMUNE(R) is comprised of HIV that has been chemically killed and inactivated so that it is non-infectious. During the inactivation process, the HIV outer envelope, which is prone to rapid mutations, is removed. REMUNE(R) is then emulsified in Incomplete Freund's Adjuvant, an agent that elicits a more potent immune response by drawing the immune system's attention to the inactivated virus.
HIV, the human immunodeficiency virus, is the virus that causes AIDS, a condition that slowly destroys the body's immune system, making it vulnerable to infections. More than 60 million people have been infected with HIV since it was first recognized in 1981. Today, 40 million people around the world are living with HIV.
This news release contains forward-looking statements. 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), the uncertainty of successful completion of any such clinical trials, whether REMUNE(R) will be effective as either a preventive or therapeutic vaccine, whether future trials will be conducted and whether the results of such trials will coincide with the results of REMUNE(R) in preclinical 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, 2002, and subsequent Quarterly Reports on Form 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(R) is a registered trademark of The Immune Response Corporation.
CONTACT: The Immune Response Corporation
Kathy Lane, 760/771-2236 (Investors), info@imnr.com
or
Sara Jones, 213/893-7300 x220 (Media)
818/326-1871 (Cell)
SOURCE: The Immune Response Corporation
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