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Biotech / Medical : IMNR - Immune Response -- Ignore unavailable to you. Want to Upgrade?

To: Alex Glavinos who wrote (1347)	5/17/1999 8:22:00 AM
From: Bob Walsh	Read Replies (2) \| Respond to of 1510

News Release Independent Panel Recommends Concluding Clinical Endpoint Trial of REMUNE; Agouron Pharmaceuticals, Inc. and The Immune Response Corporation To Pursue Alternative Regulatory Strategy CARLSBAD, Calif. and LA JOLLA, Calif., May 17 /PRNewswire/ -- The Immune Response Corporation (Nasdaq: IMNR - news) and Agouron Pharmaceuticals, Inc. (Nasdaq: AGPH - news) announced today that an independent Data Safety Monitoring Board (DSMB) completed a second interim analysis of the 2500-patient, placebo-controlled, Phase III clinical endpoint trial to evaluate the immune-based therapy REMUNE(TM) added to patients' other anti-HIV therapy. The DSMB recommended the trial be concluded at this time because differences in clinical endpoints were not observed between treatment groups and because extending the trial would be unlikely to provide sufficient additional clinical endpoints to permit statistically significant differences between the treatment groups to be observed in the near term. The number of HIV-associated clinical endpoints observed in the trial was far less than originally anticipated, which was believed to be the result of increasing use of Highly Active Antiretroviral Therapy (HAART) including HIV protease inhibitors, after the trial was initiated. The Immune Response Corporation and Agouron Pharmaceuticals, Inc. reported that separate analysis of a cohort of 250 patients randomly pre-selected for surrogate marker analysis, showed a significantly greater reduction in viral load (level of HIV RNA in plasma) after 48 and 96 weeks of treatment and significantly greater increases in lymphoctye proliferation in those who added REMUNE to their underlying anti-retroviral therapy, compared with those who did not. The Companies also reported that Agouron plans to initiate two additional phase III surrogate marker trials of REMUNE in light of an agreement previously reached with the Food and Drug Administration that an application for the marketing of REMUNE could be submitted based upon favorable virological endpoints. ''We thank the patients and clinical investigators who participated in this trial, a trial that has yielded findings significant to the design of future studies. While HAART, which became the standard of care after we initiated this trial, has been an enormous benefit to HIV patients, it has made it exceedingly difficult to conduct a trial based upon reaching clinical endpoints,'' according to Dennis J. Carlo, Ph.D., president and chief executive officer of The Immune Response Corporation. ''The significant improvements in viral load and in lymphocyte proliferation observed in the REMUNE arm of the 250 patient cohort confirm previous results and provide support for a proposed rollover study for patients currently enrolled in the clinical endpoint study. This rollover study, which is planned to be initiated in the next 2-3 months after FDA clearance, is intended to evaluate the ability of patients to maintain viral load suppression after discontinuation of anti-retroviral drugs.'' ''We believe the improved control of viral load observed in the clinical endpoint study provides strong support for new pivotal clinical trials of REMUNE to be based on virologic markers,'' said Peter Johnson, Agouron's president and chief executive officer. ''Concluding the clinical endpoint trial at this time also presents a unique opportunity to address a very contemporary question: can immune-based therapy extend the duration of the anti-HIV response induced by HAART under the most challenging conditions? The potential to produce this effect remains one of REMUNE's most important attributes.'' The Immune Response Corporation and Agouron Pharmaceuticals, Inc. entered into a collaboration in 1998 for the final development and commercialization of REMUNE, an immune-based therapy for the treatment of HIV infection. ''We look forward to working with Agouron on the next steps in our collaboration, while at the same time we continue our efforts to move ahead from our non-binding terms of collaboration with the University of Maryland Biotechnology Institute, announced May 10, 1999, toward a binding agreement regarding chemokine and HAF (hCG associated factor) technology and related matters,'' Dr. Carlo explained.