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The Immune Response Corporation and Agouron Announce the Initiation Of a Pivotal Clinical Trial of REMUNE(TM), an Investigational Immune-Based Therapy for the Treatment of HIV Infection
The Adult AIDS Clinical Trials Group (AACTG) to Conduct Multicenter Trial
CARLSBAD, Calif., and LA JOLLA, Calif., May 10 /PRNewswire/ -- The Immune Response Corporation (Nasdaq: IMNR - news) and Agouron Pharmaceuticals, Inc. today announced that a pivotal trial has been initiated to evaluate the safety and efficacy of the investigational product REMUNE(TM) (HIV-1 Immunogen) in increasing durability of viral suppression for people infected with HIV, when added onto their current antiretroviral regimens. This trial will be conducted through the Adult AIDS Clinical Trial Group (AACTG). REMUNE is the first investigational therapeutic vaccine to be tested by the AACTG in a pivotal clinical trial.
The AACTG is a multicenter cooperative clinical trials group funded by the Division of AIDS, National Institute of Allergy and Infectious Diseases of the National Institutes of Health. It is involved in various phases of clinical research, from early safety studies to large-scale efficacy trials. It evaluates new drugs and drug combinations for the treatment of HIV infection in adults.
``Previous clinical studies have suggested that when combination antiviral drug therapy is accompanied by intramuscular injections of REMUNE administered once every three months, improvements in markers of the immune response to HIV and positive trends in virologic markers are observed,'' said Fred Valentine, M.D., of Bellevue Hospital, New York University Medical Center, and Protocol Chair of the newly initiated trial. ``Based on such data, we have chosen to test REMUNE in the AACTG clinical development program.''
In clinical trials conducted to date with REMUNE, with or without antiviral drug therapy, the most frequently reported side effects include local transient pain, soreness and redness at the site of injection, muscle aches, fatigue, and headache.
The primary objective of this 96 week, randomized, double-blind, adjuvant-controlled study is to determine whether the addition of REMUNE to a regimen of potent, suppressive antiretroviral therapy delays the time to virologic relapse (defined as a predetermined level of HIV-1 RNA detected in the plasma). The trial is expected to enroll a total of 472 people and will be open to all Adult AIDS Clinical Trial Units and their subunits. The first scheduled data analysis of the trial will be conducted at 48 weeks to assess differences between control and REMUNE-treated groups in time to virological relapse.
Eligible HIV-infected patients must be receiving a stable regimen of potent antiretroviral drug therapy that has brought plasma HIV-1 RNA levels down to less than 500 copies/mL at screening and must have CD4 T cell counts greater than or equal to 300 cells per cubic millimeter at screening. Patients must initially continue on the same stable, potent, antiretroviral therapy that they were receiving at entry to the trial.
For more information on REMUNE clinical trials, dial toll-free 1-877-858-7783.
Agouron Pharmaceuticals, Inc., a wholly owned subsidiary of the Warner-Lambert Company (NYSE: WLA - news), is an integrated pharmaceutical company committed to the discovery, development, manufacturing, and marketing of innovative therapeutic products engineered to inactivate proteins that play key roles in cancer, AIDS, and other serious diseases. Agouron employs more than 1200 people of whom approximately 800 are engaged in research and development.
The Immune Response Corporation is a biopharmaceutical company based in Carlsbad, California, developing immune-based therapies to induce specific T-cell responses for the treatment of HIV, autoimmune diseases and cancer. In addition, the Company is developing a targeted delivery technology for gene therapy which is designed to enable the intravenous injection of genes for delivery to the liver. The Company's gene therapy program is currently focused on diseases of the liver.
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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.
Agouron® is a registered trademark of Agouron Pharmaceuticals, Inc.
SOURCE: The Immune Response Corporation; Agouron Pharmaceuticals, Inc.