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OCLASSEN's FIAC PHASE II IND FILING FOR CYTOMEGALOVIRUS RETINITIS

Executive Summary

OCLASSEN's FIAC PHASE II IND FILING FOR CYTOMEGALOVIRUS RETINITIS and CMV gastroenteritis in AIDS patients has been submitted to FDA, the company announced Sept. 5. Oclassen said that Phase II trials, co-sponsored by the National Institutes of Health AIDS Clinical Trials Group (ACTG), could begin as early as late September. Oclassen is petitioning FDA to accept Phase I safety data on FIAC from clinicals conducted in patients with herpes group infections by Memorial Sloan-Kettering under an existing IND so that it may go directly into Phase II AIDS trials. Data has been collected on FIAC (fluoro-iodo-arabinosylcytosine) in over 100 immune-compromised patients, the company said. In September 1988, Oclassen was granted exclusive worldwide license from Memorial Sloan-Kettering to develop and market two antiviral fluorinated pyrimidine agents FIAC and FIAU (fluoro-iodo-arabinosyluracil). FIAU had been developed by Sloan-Kettering under an agreement with Bristol-Myers that was discontinued in 1985. The firm plans to file an NDA for FIAU in herpes group infections by the first quarter of 1990. Scheduled to last approximately six months, the Phase II trials will begin in four centers nationwide, with an enrollment of 60-70 patients. Oclassen said that studies in other immune-compromised groups such as organ transplant patients and cancer patients would soon follow. The Memorial Sloan-Kettering studies have demonstrated the efficacy of FIAC in several viruses related to CMV, the company noted, "including herpes-zoster virus, herpes simplex 1 and 2, and Epstein-Barr virus." Although FIAC has been found to "cause reversible gastrointestinal and hematologic toxicities at high dose," at lower doses the drug is "well tolerated," Oclassen remarked. The company pointed out that in vitro FIAC has been shown to be "up to ten times" more potent against CMV than ganciclovir, Syntex's recently approved intravenous product Cytovene. FIAC may be administered orally or intravenously. Oclassen is located in San Rafael, California. The company has had an NDA pending since December 1987 for a topical genital wart treatment Condylox (.5% podophyllotoxin). In the OTC area, the firm has a joint development agreement with Neutrogena, under which the latter will develop and market dermatologic products originating from Oclassen research. The company's founder and president is Glenn Oclassen, who was president of Neutrogena's dermatologics division. He is the son of Charles Oclassen, founder of Westwood Pharmaceuticals. Oclassen VP-Research and Development Dannie King, PhD, joined the company in 1986 after 14 years at Burroughs Wellcome, where he was director of drug research for Zovirax (acyclovir) and Retrovir (AZT).
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