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Executive Summary

ASTRA'S FOSCARNET EXPANDED PHASE II CLINICALS WILL BEGIN IN MARCH, the company said following a Jan. 30 FDA press release on new studies for experimental AIDS drugs. The new Phase II trial will involve 268 individuals with a second episode of cytomagalovirus, having failed treatment with Syntex' Cytovene (ganciclovir). Phase II trials with foscarnet initially began in September 1988 in three centers. The study included 60 patients with first-episode cytomegalovirus retinitis, an AIDS-related opportunistic infection. In conjunction with the National Institutes for Allergy and Infectious Diseases, Astra is recruiting 180 more patients to expand the trials to six centers. Westboro, Massachussetts-based Astra said it is planning to file for Treatment IND distribution of foscarnet as soon as sufficient data have been collected. Controlled clinical trials of ganciclovir are being conducted under a Treatment IND approved in November. Both foscarnet and ganciclovir are being studied at NIAID's National Eye Institute. A study reported in the Feb. 2 issue of the New England Journal of Medicine suggests that foscarnet may also be useful in the treatment of mucotaneous infections due to acyclovir-resistant herpes simplex virus in AIDS patients. A patient who relapsed after treatments with acyclovir was given foscarnet at a dose of 50 mg per kg three times daily. At the end of 16 days lesions due to the infections disappeared and did not return.

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