CoCensys, Inc. Achieves Clinical Milestone; Initiates Phase II Clinical Trials of Lead Anticonvulsant Compound.IRVINE, Calif.--(Health Wire)--January 4, 1995--CoCensys, Inc. (Nasdaq: COCN) today announced the initiation of its international Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II program for CCD CCD in full charge-coupled device Semiconductor device in which the individual semiconductor components are connected so that the electrical charge at the output of one device provides the input to the next device. 1042, its lead anticonvulsant anticonvulsant /an·ti·con·vul·sant/ (-kon-vul´sant) inhibiting convulsions, or an agent that does this. an·ti·con·vul·sant n. A drug that prevents or relieves convulsions. compound. The series of Phase II clinical trials, which began in December 1994, will be conducted in parallel at various trial sites in the United States and Europe to evaluate the anticonvulsant activity and tolerability of CCD 1042 in patients with epilepsy. CCD 1042 is a synthetically modified Epalon compound developed at CoCensys and is modeled after naturally occurring human neurosteroids that have a calming effect on the central nervous system (CNS See Continuous net settlement. CNS See continuous net settlement (CNS). ). Phase II studies will address the potential efficacy of CCD 1042 in a broad range of epileptic disorders. In 1994, the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) granted CCD 1042 orphan drug status for infantile spasm, a form of epilepsy commonly known as West Syndrome. Phase I trials completed to date have characterized the pharmacokinetic profile of the compound and demonstrated that CCD 1042 is well tolerated. "We are pleased to have initiated our international Phase II clinical program for CCD 1042 on schedule," said Daniel L. Korpolinski, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of CoCensys. "As a result of our Ciba CNS co-promotion collaboration, our company's 60-person sales and marketing organization is already in the field establishing company identity for promoting drugs in the same therapeutic indications as those now under development at CoCensys, as well as bringing revenue into our company to support our development programs." CoCensys is a biopharmaceutical company that discovers, develops and markets products to treat neurological and psychiatric disorders. The Company's product development programs focus on two novel, proprietary classes of compounds: Epalons, to treat epilepsy, anxiety and sleep disorders, and Glystasins, to treat stroke and head trauma, chronic pain and epilepsy. Through its co-marketing alliance with Ciba Pharmaceuticals, CoCensys also markets several CNS products, including Anafranil(R) for the treatment of obsessive compulsive disorder Obsessive compulsive disorder (OCD) Disorder characterized by persistent, intrusive, and senseless thoughts (obsessions) or compulsions to perform repetitive behaviors that interfere with normal functioning. Mentioned in: Tourette Syndrome and Tofranil PM for depression. CONTACT: Daniel L. Korpolinski President and CEO CoCensys, Inc. (714) 753-6100 Karen Bergman (Media Relations) Lilian S. Stern (Investor Relations) Burns McClellan (212) 505-1919 |
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