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| |  DepoTech Begins Filing of New Drug Application for DepoCyt SAN DIEGO—Nov. 25, 1996 -- DepoTech Corp. (NASDAQ:DEPO) Monday announced the filing of the Chemistry, Manufacturing and Controls (CM&C) Section of a New Drug Application (NDA) with the U.S. Food and Drug Administration for DepoCyt, an anti-cancer drug, in patients with neoplastic meningitis (NM) arising from solid tumors. The NDA is being submitted in accordance with the so-called "rolling NDA" procedure under which the CM&C Section of the submission may be filed first. The remaining sections of the NDA for the solid tumor indication will be filed as soon as practicable. Results of a pivotal clinical trial of DepoCyt in solid tumor patients showed a higher complete response rate, higher median survival and longer time to NM disease progression compared to the control drug, methotrexate (MTX). The Phase III clinical trial was a multicenter, controlled, non-blinded study of DepoCyt in which patients were randomized to treatment with either DepoCyt or MTX. DepoTech along with its partner, Chiron Corp., plan to continue pivotal Phase III studies of DepoCyt in NM arising from leukemia and lymphoma. In addition, a multicenter Phase IV study of DepoCyt for the treatment of NM arising from solid tumors is under way in the U.S. and Canada to collect further data relating to safety and efficacy. Chiron is currently conducting trials of DepoCyt in Europe. When commercially available, DepoCyt will be marketed by Chiron in the United States, Canada and Europe, and manufactured by DepoTech at its San Diego production facility. Neoplastic meningitis occurs when metastases from solid tumors, leukemia or lymphoma spread to the tissue surrounding the brain and spinal cord. Conventional therapy requires frequent, repeated injections and has limited efficacy. DepoCyt is an injectable, sustained-release formulation of the chemotherapy agent cytarabine encapsulated in DepoFoam, DepoTech's proprietary, lipid-based drug-delivery technology. DepoTech is a drug-delivery company dedicated to the development and manufacture of innovative sustained-released therapeutic products based on DepoFoam. Products are being developed to treat major unmet medical in fields such as cancer, infectious diseases, pain management and rheumatology. This news release contains forward-looking statements regarding DepoTech and Chiron. Actual results could differ materially from those described in this news release as a result of a number of factors, including, but not limited to the following: There can be no assurance that any product in the DepoTech and Chiron collaborative product pipeline will be successfully developed or manufactured, or that final results of human clinical trials will be supportive of regulatory approvals required to market products, or that final regulatory approval will be received in a timely manner, if at all, or that patient and physician acceptance of these products will be achieved.
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