Cypros Pharmaceutical broadens clinical scope of CPC-211 drug with Phase II trial in closed head injury patients.CARLSBAD, Calif.--(BUSINESS WIRE)--Aug. 10, 1995--Cypros Pharmaceutical 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 :CYPR) Thursday announced that it has broadened the clinical scope of its CPC-211 drug by beginning a Phase II trial in closed head injury patients. Closed head injury is a trauma generally resulting from motor vehicle accidents motor vehicle accident Public health A morbid condition that kills 45,000/yr–US; 60% are < age 35; MVAs account for 500,000 hospitalizations and most 20,000 spinal cord injuries, at a cost of $75 billion/yr , assaults or falls. In these cases, where the brain collides with the skull, the brain swells and blood flow to the brain is compromised, resulting in lack of oxygen (ischemia). As a result of ischemia, lactic acid lactic acid, CH3CHOHCO2H, a colorless liquid organic acid. It is miscible with water or ethanol. Lactic acid is a fermentation product of lactose (milk sugar); it is present in sour milk, koumiss, leban, yogurt, and cottage cheese. accumulates to toxic levels in the brain, causing permanent damage. The CPC-211 drug is designed to stimulate a key metabolic enzyme which prevents such accumulation of lactate Lactate A salt or ester of lactic acid (CH3CHOHCOOH). In lactates, the acidic hydrogen of the carboxyl group has been replaced by a metal or an organic radical. Lactates are optically active, with a chiral center at carbon 2. . The closed head injury trial, like the company's Phase II stroke victim trial currently ongoing, will be a single-center, double-blind, 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. , placebo-controlled, ascending dose-ranging study A dose-ranging study is a clinical trial where different doses of an agent (e.g. a drug) are tested against each other to establish which dose works best and/or is least harmful. Dose-ranging is usually a phase I or early phase II clinical trial. . CPC-211 will be administered intravenously as a single dose. Serial blood and cerebro-spinal fluid levels of lactate and CPC-211 will be measured. Dr. Anthony Fox, vice president, drug development of Cypros, commented: "This trial is the second trial in a broader strategy to characterize the pharmacology of the drug in stroke and head injury patients. Furthermore, we may be able to compare the lactate- lowering effects of CPC-211 in the blood and the brain, thus enabling us to efficiently identify the effective dose." Cypros Pharmaceutical is developing small-molecule drugs that facilitate the body's ability to generate metabolic energy under ischemic Ischemic An inadequate supply of blood to a part of the body, caused by partial or total blockage of an artery. Mentioned in: Antiangiogenic Therapy, Subarachnoid Hemorrhage, Ventricular Fibrillation ischemic (low blood flow) conditions. The company has two lead product candidates, CPC-111 (currently in Phase II trials for patients with decompensated heart failure, and cardiac bypass) and CPC-211 (currently in a Phase II trial in stroke victims), both of which facilitate tissue recovery from ischemic trauma. CONTACT: Cypros Pharmaceutical Corp., Carlsbad David Nassif, 619/929-9500 or Financial Sciences of America Francesca Daniels, 310/278-4413 |
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