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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: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 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 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.

Cypros is a Carlsbad-based company developing small molecule drugs that facilitate a process called anaerobic glycolysis, 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, 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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Publication:Business Wire
Date:Feb 22, 1995
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