DepoTech begins Phase I clinical trial for DepoMorphine.SAN DIEGO--(BUSINESS WIRE)--March 25, 1997--DepoTech Corp. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :DEPO DEPO Delegated Episcopal Pastoral Oversight DEPO Devils Postpile National Monument (US National Park Service) DEPO Defence Export Promotion Organization (Pakistan) DEPO Double Even Pass Odd ) Tuesday announced that it has begun a Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I of DepoMorphine sustained-release encapsulated morphine sulfate morphine sulfate, n brand names: Duramorph PF, MS Contin, Roxanol; drug class: narcotic analgesic (Controlled Substance Schedule II); action: being developed to treat acute post-surgical pain. Based on DepoFoam technology, DepoMorphine is targeted at a broad range of surgical procedures -- from orthopedic and deep abdominal surgeries to Caesarean sections. The Phase I clinical trial is a dose-escalation study that will assess the safety and pharmacokinetics of single doses of DepoMorphine administered epidurally to healthy volunteers. The study will also provide a preliminary assessment of DepoMorphine's ability to inhibit the transmission of pain. 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 anesthesiology (ăn'ĭsthē'zēŏl`əjē), branch of medicine concerned primarily with procedures for rendering patients insensitive to pain, and for supporting life systems under the strains of anesthesia and surgery. , Stanford University Medical Center Stanford University Medical Center (Stanford Hospital & Clinics) is one of four hospitals affiliated with Stanford University and Stanford University School of Medicine, along with the Lucile Packard Children's Hospital, the Veteran's Administration Hospital in Palo Alto, and Santa . "DepoMorphine, the company's third product to enter the clinic, is designed to increase the duration of pain control and reduce the cost and inconvenience associated with current pain management procedures, which often require repeat injections or an indwelling catheter indwelling catheter Any catheter, usually understood to be for the urinary bladder–eg, a 'Foley' left in place for a prolonged period of time ," said Edward L. Erickson, president and chief executive officer of DepoTech. "Preclinical studies preclinical studies, n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research. show that DepoMorphine releases drug over several days with a single injection." The DepoFoam drug delivery system is composed of microscopic, spherical particles that can be used to encapsulate en·cap·su·late v. 1. To form a capsule or sheath around. 2. To become encapsulated. en·cap a variety of medically important compounds. A lipid-based formulation, DepoFoam particles are non-toxic and biodegradable and have been shown to date to be well-tolerated in patients. When injected into the body, DepoFoam formulations provide sustained release of the active drug which allows for less-frequent dosing. DepoTech is a drug delivery company dedicated to the development and manufacture of innovative, sustained-release therapeutic products based on DepoFoam technology. Products are being developed to treat unmet medical needs in fields such as cancer, infectious diseases, pain management and rheumatologic diseases. The company is currently completing the filing of a New Drug Application for its lead product, DepoCyt, an anti-cancer therapeutic for the treatment of neoplastic meningitis (also known as leptomeningeal metastases leptomeningeal metastases Oncology CA that has spread to the pia and arachnoid membranes of the brain and spinal cord ) arising from sold tumors and is continuing Phase III clinical trials for leukemia and lymphoma indications. -0- NOTE: This news release contains forward-looking statements regarding DepoTech Corp.'s programs for DepoMorphine and DepoCyt. 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 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. Additional written materials and recent releases regarding DepoTech are available on the World Wide Web at http://www.depotech.com CONTACT: DepoTech Corp., San Diego Edward L. Erickson, 619/625-2424 or StratiPoint Group, San Francisco Mike Jackman, 415/388-3216 |
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