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Executive Summary

GENELABS GLQ223 WILL BE USED IN COMMUNITY-BASED AIDS TRIAL sponsored by Project Inform under an IND approved March 7 by FDA. The agency "has granted a separate, independent IND...license to Project Inform CRA [Community Research Alliance]," the AIDS activist group said in a March 9 press release. In a same-day release, Genelabs announced that it will supply GLQ223 free of charge to Project Inform and that the company's marketing partner, Sandoz, will donate $250,000 to the group "to defray the administrative costs of re-treating with GLQ223." Sandoz holds worldwide rights to the drug under a licensing agreement with Genelabs. Under the approved IND protocol, San Francisco-based Project Inform will treat about 100 patients with GLQ223, a purified derivative of the Chinese cucumber extract, tricosanthin. Patients were treated last year, without FDA consent, with an unpurified version of tricosanthin, commonly called Compound Q. Of the 60 patients in the unauthorized Project Inform trial, two died and three others suffered from severe dementia or seizures. The study protocol approved by FDA calls for randomization of patients into two groups, one receiving GLQ223 every three weeks and the other receiving the drug every six weeks. "Our goal is to evaluate the safety and effectiveness of the drug in long-term treatment use, under real-world conditions," Project Inform said. The group noted that patients will continue to receive other AIDS therapies concomitantly. Last August, FDA asked Project Inform to halt further study of Compound Q in HIV-infected patients until the group obtained an approved IND ("The Pink Sheet" Aug. 14 T&G-2). At that time, Center for Drug Evaluation and Research Director Carl Peck suggested that community-based clinical research might supplement drug research by corporate sponsors. Genelabs' GLQ223 clinical trials, begun in May 1989, are in Phase I/II at the University of California San Francisco-affiliated San Francisco General Hospital and other clinical centers. Preliminary findings from the Genelabs trials will be submitted to FDA for review in mid-1990, the press release states. Project Inform CRA will use a dosing regimen similar to that of the Genelabs GLQ223 trials. Genelabs said that it has no plans at this time to include the data from the Project Inform studies into the NDA for GLQ223, although they will review the data once the study is complete.

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