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Biotech / Medical : wla(warner lambert) -- Ignore unavailable to you. Want to Upgrade?

To: Anthony Wong who wrote (625)	3/26/1999 5:38:00 AM
From: Henry Niman	Respond to of 942

The Rezulin FDA review is well covered by many newspapers and wire services. Several links are in the TZD table at biocognizance.com (including a recent LA Times article on 155 Rezulin suspected deaths)

To: Anthony Wong who wrote (625)	3/26/1999 7:51:00 AM
From: John F Beule	Read Replies (1) \| Respond to of 942

The Immune Response Corporation Announces Data Safety Monitoring Board Meeting CARLSBAD, Calif., March 26 /PRNewswire/ -- The Immune Response Corporation (Nasdaq: IMNR) today announced that the independent Data Safety Monitoring Board (DSMB) for its REMUNE(TM) pivotal Phase 3 clinical endpoint trial met prior to conducting its scheduled interim analysis and decided, as a procedural matter, to postpone reviewing the clinical endpoint data until virological data was also available for review. After all data is available, the interim analysis will be conducted in the coming weeks. "Data regarding the levels of virus in the plasma, when combined with clinical endpoint data, will allow the DSMB to better assess the value of this trial," stated the Principal Investigator of the trial, James Kahn, M.D., Associate Professor of Clinical Medicine at the University of California, San Francisco. According to Stephen W. Lagakos, Ph.D., who serves as the biostatistician for the study and is the scientific director of the Center for Biostatistics in AIDS Research at Harvard School of Public Health, "The data provided by this trial are very important in determining the role of REMUNE in the treatment of HIV infection. Additional data will give us important virological and clinical endpoint information. The DSMB has also authorized an extension of the study, through the end of the year if needed." The DSMB, an independent group of experts, has been monitoring this Phase 3 double-blind, placebo-controlled study to evaluate REMUNE in combination with, or without, antiviral drugs. This pivotal trial involves approximately 2,500 patients at 74 centers in the U.S. In preparation for their meeting, the DSMB will conduct a four-step process. This process includes gathering additional patient virological data, conducting a medical evaluation of the data in conjunction with other patient information, performing the statistical analyses and reviewing the resultant information along with the clinical endpoint data. This process is expected to occur in the coming weeks. After the DSMB meeting occurs, the Company will issue a statement regarding the DSMB recommendation. It has been previously reported in scientific journals that HIV-specific immunity plays an important role in controlling HIV infection. Published studies show that REMUNE stimulates the immune system against the virus and also stimulates production of specific antiviral substances, such as chemokines, by the immune system and naturally protects T cells from HIV infection. By utilizing an immune-based therapy such as REMUNE it may be possible to stimulate the natural immune defense system against the virus and further optimize the effects of antiviral drug therapy. Dr. Kahn also stated, "While highly active antiretroviral therapy (HAART) has been useful in reducing replication of HIV, it is less successful at reconstituting HIV-1 specific immunity. Thus, complementary therapies are needed to continue advancement of HIV treatments." REMUNE is an immune-based therapy currently in development by The Immune Response Corporation and Agouron Pharmaceuticals, Inc. for the treatment of HIV infection. 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. The Company is conducting clinical trials for its immune-based therapies for HIV, rheumatoid arthritis, psoriasis, multiple sclerosis, colon cancer and brain cancer and preclinical studies for melanoma and prostate cancers. 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 directly to the liver. The Company's gene therapy program is focused on diseases of the liver and is in preclinical studies for the treatment of hemophilia and hepatitis. NOTE: The Immune Response Corporation news releases are available at no charge through the company's automated attendant 800 number at 800-491-0153. News releases are also available through PR Newswire's Company News On-Call fax service. For a menu of available news releases or to retrieve a specific release made by The Immune Response Corporation, please call 800-758-5804, extension 434675. Please retain these numbers for future reference. Company information can also be located on the Internet Web Site: imnr.com. This news release contains forward-looking statements. Actual results could vary materially from those expected due to a variety of risk factors, including the uncertainty of successful completion of clinical trials, and those risks set forth from time to time 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, 1997. The company undertakes no obligation to publicly release the result 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 Immune Response Corporation CO: Immune Response Corporation; Data Safety Monitoring Board ST: California IN: MTC SU: 03/26/99 07:00 EST prnewswire.com To edit your profile, go to keyword NewsProfiles. For all of today's news, go to keyword News.