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| |  DepoMorphine Investigational New Drug Application Filed SAN DIEGO—Dec. 9, 1996 -- DepoTech Corp. (NASDAQ:DEPO) Monday announced that is has filed an Investigational New Drug ("IND") Application with the U.S. Food and Drug Administration to begin a Phase I clinical trial of DepoMorphine, a sustained-release DepoFoam formulation of morphine used to treat acute post-surgical pain. DepoMorphine is being evaluated for a broad range of surgical procedures -- from orthopedic and deep abdominal surgeries to Cesarean sections. The Phase I clinical trial is a dose-escalation study that will assess the safety, tolerability and pharmacokinetics of single doses of DepoMorphine administered epidurally to healthy volunteers. Up to 30 subjects will be enrolled. The study will be conducted at the Palo Alto Veterans Administration Health Care System under the leadership of Steven Shafer, M.D., and Donald Stanski, M.D., from the Department of Anesthesiology, Stanford University Medical Center. DepoFoam is composed of microscopic, spherical particles that can be used to encapsulate a wide variety of medically important compounds. A lipid-based formulation, DepoFoam is nontoxic and biodegradable, and has been shown to date to be well-tolerated in patients. When injected into the body, DepoFoam provides sustained release of the active drug which allows for less requent dosing. 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 needs in fields such as cancer, infectious diseases, pain management and rheumatology. The company's lead product is DepoCyt, an anti-cancer therapeutic, which has completed Phase III clinical trials for neoplastic meningitis (also known as leptomeningeal metastases) arising from solid tumors and is in Phase III clinical trials for leukemia and lymphoma indications. This press release contains forward-looking statements regarding DepoTech Corporation. Actual results could differ materially from those described in this press 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 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. The company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this release.
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