Cypros Pharmaceutical Corp. begins Phase II trials of CPC-111 in cardiac bypass patients.CARLSBAD, Calif.--(BUSINESS WIRE)--Feb. 22, 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) Wednesday announced that patient recruitment has begun for its Phase II trial of CPC-111 in cardiac bypass patients. The single-center, double-blind, placebo-controlled trial taking place is examining post-operative myocardial myocardial /myo·car·di·al/ (-kahr´de-al) pertaining to the muscular tissue of the heart. myocardial pertaining to the muscular tissue of the heart (the myocardium). performance of bypass patients when infused with CPC-111 beforehand and myocardial performance when CPC-111 is added to the cold solution that the heart is stored in when it is stopped as part of the bypass surgery, including coronary artery bypass grafting, valve replacement and transplantation procedures. In commenting on the announcement, Anthony W. Fox, M.D., Ph.D., the company's vice president of drug development, said: ``This is the second of several Phase II studies with CPC-111 in disease states covered by the company's four patents on CPC-111. Cardioplegia or cardiac standstill is required for heart surgery, but is also a major 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 insult to the heart. ``These patients proceed to the intensive care unit for management of pain, breathing, fluid management and heart function. Approximately 350,000 Americans have heart surgery each year involving the bypass procedure. We are hoping at a minimum to improve heart performance post-operatively and shorten patient stays in the ICU through the administration of CPC-111.'' The Cypros trial will be conducted in Great Britain, where the Medicines Control Agency recently approved the company's CTX application (the United Kingdom equivalent of an IND) without any requirement to do a Phase I trial first. The trial will be conducted under GCP conditions using GMP drug product and, thus, will be submissible under the company's existing IND on file with the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. . Cypros is a Carlsbad-based company developing small molecule drugs that facilitate a process called anaerobic anaerobic /an·aer·o·bic/ (an?ah-ro´bik) 1. lacking molecular oxygen. 2. growing, living, or occurring in the absence of molecular oxygen; pertaining to an anaerobe. glycolysis glycolysis (glīkŏl`ĭsĭs), term given to the metabolic pathway utilized by most microorganisms (yeast and bacteria) and by all "higher" animals (including humans) for the degradation of glucose. , which is the body's ability to generate metabolic energy under ischemic (low blood flow) conditions. The company has two lead product candidates, CPC-111 (currently in Phase II trials for adult respiratory distress syndrome Adult Respiratory Distress Syndrome Definition Adult respiratory distress syndrome (ARDS), also called acute respiratory distress syndrome, is a type of lung (pulmonary) failure that may result from any disease that causes large amounts of fluid to , cardiac surgery and decompensating heart failure) and CPC-211, which successfully completed a Phase I trial in January 1995. CONTACT: Cypros Pharmaceutical Corp., Carlsbad David W. Nassif, 619/929-9500 |
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