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ICN's VIRAZOLE RE-ENTERING CLINICALS IN PHASE I/II LAS/ARC STUDY

Executive Summary

ICN's VIRAZOLE RE-ENTERING CLINICALS IN PHASE I/II LAS/ARC STUDY approved by FDA Oct. 16. In a letter to ICN, FDA Commissioner Young said the agency has authorized an IND protocol "for undertaking a new Phase I/II clinical study, testing ribavirin in 32 patients at high risk with Lymphadenopathy Syndrome (LAS) and AIDS-Related Complex (ARC)." The study will be conducted at the Cornell Medical Center by investigator Richard Roberts, MD. The IND authorization lifts the clinical hold placed on Virazole (ribavirin) last April. However, FDA appears to be asking ICN to start over in its testing of Virazole in AIDS. FDA emphasized in its letter to ICN that the lifting of the IND hold does not imply approval for the company's application for a Treatment IND. That application has been pending at FDA since last spring. Based on a review of the study results from ICN's earlier ARC and LAS studies with Virazole, FDA acknowledged that "our safety concerns are not of sufficient magnitude" to withhold approval of "further" safety and efficacy studies. "Accordingly," Young added, "the clinical hold has been lifed so that this study may be conducted." FDA has twice rejected ICN's request for a Treatment IND for Virazole -- the first time in April and, more recently, in August ("The Pink Sheet" Sept. 7, p. 11). FDA put a clinical hold on Virazole studies in AIDS in response to safety concerns stemming from increased mortality in the Virazole group during ICN's ARC study. ICN's statistical reanalysis of the Virazole clinical data apparently helped mollify FDA's safety concerns. The ICN reanalysis was supported by outside reviews contracted by the company.
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