Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.
Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.
Reuters NewMedia - Monday May 17, 1999
A corrected repetition follows.
CARLSBAD, Calif., May 17 (Reuters) - Immune Response Corp. (Nasdaq:IMNR - news) said Monday that an independent Data Safety Monitoring Board recommended ending its Phase III trial of REMUNE, an anti-HIV therapy.
Immune Response and partner Agouron Pharmaceuticals Inc. (Nasdaq:AGPH - news) were advised to terminate the trials because differences were not observed between placebo and treatment groups and were unlikely to be observed near term, Immune Response said.
Immune Response said that the monitoring board completed a second analysis of the 2500-patient, placebo-controlled clinical trial and found the number of HIV-associated clinical endpoints observed in the trial was far less than originally anticipated.
REMUNE, an immune-based therapy which is added to patients' other drugs for HIV infection, was discovered by Immune Response. In June 1998, Immune Response and Agouron said that they agreed to collaborate on developing and commercializing the drug, in a pact worth up to $77 million to Immune Response over two years.
The company said it believes that the lack of significance between the groups was the result of increasing use of another effective anti-HIV drug, Highly Active Antiretroviral Therapy (HAART) including HIV protease inhibitors, after the trial was initiated.
Further details about the endpoints, or clinical results targets, in question were not immediately available.
Separately, Immune Response said that an analysis of 250 patients pre-selected for surrogate marker analysis showed a significantly greater reduction in viral load after 48 and 96 weeks of treatment. It said that the analysis showed significantly greater increases in lymphoctye proliferation in those who added REMUNE to their underlying anti-retroviral therapy, compared with those who did not.
The company said 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 targets.
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