DepoTech commences Phase III trials of DTC 101 in Canada.LA JOLLA, Calif.--(BUSINESS WIRE)--Nov. 3, 1994--DepoTech Corp. Thursday announced the start of multi-center Canadian Phase III clinical trials for DTC DTC See: Depository Transfer Check DTC See: Depository Trust Company DTC See Depository Trust Company (DTC). 101, an anti-cancer therapeutic, in patients with neoplastic meningitis. Neoplastic meningitis is a complication of many forms of cancer that occurs when tumors metastasize me·tas·ta·size v. To be transmitted or transferred by or as if by metastasis. Metastasize Spread of cells from the original site of the cancer to other parts of the body where secondary tumors are formed. to the soft-tissue covering the brain and spinal cord spinal cord, the part of the nervous system occupying the hollow interior (vertebral canal) of the series of vertebrae that form the spinal column, technically known as the vertebral column. (the meninges meninges (mĭnĭn`jēz), three membranous layers of connective tissue that envelop the brain and spinal cord (see nervous system). The outermost layer, or dura mater, is extremely tough and is fused with the membranous lining of the skull. ). In the controlled, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. Phase III clinical trials, which are an expansion of ongoing trials in the United States, patients with three subtypes of neoplastic meningitis arising from solid tumors, leukemia or lymphoma will receive either DTC 101 or the standard anti-cancer therapy administered into the cerebrospinal fluid (CSF Cerebrospinal Fluid (CSF) Analysis Definition Cerebrospinal fluid (CSF) analysis is a laboratory test to examine a sample of the fluid surrounding the brain and spinal cord. ). The primary endpoints of the studies are clearing of cancer cells from the CSF; time to complete response; duration of response; and time to relapse. DTC 101 is an injectable, sustained-release formulation of the chemotherapeutic agent ara-C (cytarabine) that consists of the drug encapsulated in DepoFoam, DepoTech's novel lipid-based drug delivery system. DepoFoam-encapsulation provides a mechanism for sustained-release of drug over a period of weeks. DepoTech is developing DTC 101 in collaboration with Chiron Therapeutics, a business unit of Chiron Corp., which has exclusive marketing rights to the drug in the U.S., Canada and Europe. "In addition to providing information for Canadian approval of DTC 101, these new trials will support our data acquisition for the U.S. New Drug Application," commented Edward L. Erickson, president and chief executive officer of DepoTech. DepoTech Corp. is a drug delivery company engaged in the development and manufacture of sustained-release therapeutic products based on DepoFoam, a proprietary injectable depot drug delivery technology. CONTACT: DepoTech Corp. Edward L. Erickson, 619/625-2424 |
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