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SYNTEX' CYTOVENE IS THIRD AIDS-RELATED TREATMENT IND

Executive Summary

SYNTEX' CYTOVENE IS THIRD AIDS-RELATED TREATMENT IND to clear FDA, following approval Nov. 29. The drug will be available to AIDS "patients with immediately sight-threatening CMV [cytomegalovirus] retinitis," FDA said in a November 30 press release. The treatment IND is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID). At the same time that the Treatment IND is getting underway, Syntex and NIAID are also initiating a controlled clinical trial for Cytovene (ganciclovir) that will include patients "with newly diagnosed AIDS-related CMV retinitis that is not immediately sight-threatening, estimated to be about 20 patients a month," the joint FDA/NIAID press release states. The controlled comparative study, to be conducted at Syntex clinical sites as well as NIAID AIDS Clinical Trial Units, will randomly divide patients into two groups: one group will begin immediate intravenous treatment with Cytovene while the control group will receive delayed treatment. Patients in the control group showing signs of worsening clinical condition will be given the drug. CMV retinitis afflicts immune-compromised patients such as organ transplant recipients and people with AIDS. Syntex has been supplying the antiviral agent to both patient groups since February 1985 on a compassionate use basis, and will continue supplying the drug cost-free to current compassionate use AIDS patients under the randomized clinical trial or the Treatment IND. Other immune-compromised groups will continue to receive Cytovene on a compassionate use basis. Patient enrollment for the peripheral CMV retinitis study will begin early January through the Maryland-based Ganciclovir Study Center. Biospherics Inc. has group retained by Syntex to coordinate drug distribution to all patient groups. A NIAID spokesperson predicted that, unless conclusive data is collected through early interim analyses, the trial may require up to 180 patients and last as long as two years. Pending since December 1986, the Cytovene NDA was considered by FDA's Anti-Infective Drug Products Advisory Committee in 1987 but was rejected by an 11-2 vote for lack of sufficient clinical data. Representatives from Syntex and NIAID met frequently with FDA staffers this fall and, through a collaborative effort, produced the drug development package. The Treatment IND and comparative study combination provides one recourse to resolve FDA's impasse over the Cytovene NDA, allowing for continued supply of drugs to patients while performing the necessary clinical studies to gain NDA approval. "Syntex, NIAID and the FDA have designed a framework," FDA Commissioner Frank Young, MD, noted in the release, "that will meet the needs of all patients who may benefit from treatment with ganciclovir."

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