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FDA TO MEET WITH COMPOUND Q COMMUNITY TRIAL SPONSOR

Executive Summary

FDA TO MEET WITH COMPOUND Q COMMUNITY TRIAL SPONSOR during the first week in September. The meeting follows an Aug. 7 FDA letter asking Project Inform to halt further study of the compound without an approved IND. In the letter to Project Inform Co-Executive Director Martin Delaney, FDA Center for Drug Evaluation and Research Director Carl Peck asked the group to discontinue its work on Compound Q (trichosanthin) until it can meet with FDA to work out a better approach to studying the relatively toxic agent. "We feel that you should discontinue any further unapproved experimentation with trichosanthin and should not initiate any new use of trichosanthin without a valid IND," Peck stated. Peck also suggested that the meeting might include representatives from Genelabs, which is conducting its own studies with a trichosanthin derivative, GLQ-223. Peck said that FDA "stands ready to meet immediately with the Project Inform trichosanthin investigators and possibly representatives from [Genelabs] to determine if a cooperative community-based evaluation of trichosanthin can safely and usefully be conducted in compliance with applicable laws and regulations." Delaney agreed to discuss the viability of community-based trials at the meeting, which had previously been scheduled only to present results from the Compound Q study, the San Francisco-based AIDS activist group said. The study protocol, which called for a treatment regimen of three injections in one-week intervals, was completed last month and Project Inform has since been monitoring patients. The group said it administered 17-25 mcg/kg per dose in 50 patients in three cities: San Francisco, Los Angeles and New York. Initial results have shown "evidence of antiviral activity," according to the sponsors, with a maximum effective dose at 25 mcg/kg. Beyond that dose, incidents of rashes, muscle aches, fever and AIDS-related dementia have been reported. FDA announced in late June that it was investigating the community trial following reports of at least one death associated with use of Compound Q. At that time, Project Inform reported that 42 patients had received the drug. Peck noted in the letter that the agency is "aware" of Project Inform's July 27 statement of "your intent to continue [experimental use of trichosanthin] despite the report of deaths and significant toxicity associated with this agent." However, Peck also expressed FDA's general support for community-based clinical research as a way of supplementing drug research by corporate sponsors. "We believe that community organizations, such as yours, may become a part of the drug evaluation process through cooperation between community-based researchers and approved manufacturers of investigational agents," Peck said. "Such cooperative efforts between drug manufacturers with valid INDs and community-based researchers can provide benefits to both the manufacturer and researchers." Peck noted that use of a standardized product in trials is "particularly important in the case of a protein product such as trichosanthin." He cited the "unknown and potentially variable purity" of the product distributed by Project Inform. The use of such a product "not only [increases] the risks of toxicity from incorrect dosing and contaminants, but may also make it difficult or impossible to know how to compare the results obtained from the trials of different trichosanthin products," he said. Project Inform says it considers Peck's discussion of the role of community-based research in the drug evaluation process a "positive step." In an Aug. 11 telephone conversation with FDA's San Francisco district office, Delaney offered to provide the agency a sample of the drug to answer FDA's questions about the drug's purity.
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