Cypros Pharmaceutical Corporation Begins A Pivotal Phase III Clinical Trial In Sickle Cell Disease
CARLSBAD, Calif.--(BUSINESS WIRE)--June 16, 1998--Cypros Pharmaceutical Corporation (AMEX:CYP - news) announced today that it has begun recruiting clinical trial sites and chosen a contract research organization to both conduct and manage the Company's first multi-center phase III clinical trial of its Cordox drug in treating the painful vaso-occlusive episode (VOE) of sickle cell disease. The double-blind, placebo-controlled, trial will be conducted at approximately 30 medical centers in the United States and will enroll a total of 280 patients. Endpoints of the study will include pain reduction, length of hospital stay, length of VOE, and amount of narcotic use. Pre-clinical and Phase II clinical results suggest that Cordox treats both the cause of the VOE and the tissue damage that leads to the morbidity and mortality associated with this disease.
Commenting on the announcement, Paul J. Marangos, Ph.D., Chairman and Chief Executive Officer, stated, ``We are pleased to have reached this milestone of initiating Phase III trials with Cordox. Sickle cell disease, and especially the severely painful vaso-occlusive episode, is a devastating and virtually untreatable disorder. It dramatically reduces both quality and length of life. The cytoprotective effect of Cordox on ischemic tissue, coupled with its ability to reduce red blood cell sickling and improve blood flow, suggest that Cordox may be the first drug therapy to actually treat the cause of the VOE. We are excited about the opportunity of making a potentially positive impact on this disease.''
Sickle cell disease is the most prevalent genetic disorder worldwide, with carriers numbering about 3-4 million in the United States alone and about 70 - 80,000 having the full manifestation of the disease. A prominent feature of the disorder is recurring vaso-occlusive episodes where deformed (sickled) red blood cells clog blood vessels and starve tissues of oxygen. This causes severe pain and cumulative tissue damage with recurrent episodes and eventually substantial morbidity and mortality. Current treatments for VOE are palliative and involve analgesic therapy with intravenous narcotics. The Cypros drug, Cordox, is a naturally occurring intermediate of anaerobic energy generation in cells. Evidence shows it acts by directly protecting the blood starved (ischemic) tissue, maintaining the red blood cell in its normal shape, and improving blood flow; thereby treating the vaso-occlusive event at its source. Cordox is the first drug with this global physiologically relevant mechanism of action to be tested in sickle cell patients.
Sickle cell disease treatment centers, or patients seeking to receive more information on this clinical trial, should contact Catherine Turkel at 760/929-9500 or 888/297-7671.
Cypros Pharmaceutical is engaged in the development and marketing of drug products for the hospital market. The Company is pursuing a diversified strategy of marketing approved drugs and developing small molecule therapeutics that protect cells from ischemic injury. The Company currently has three products on the market, Glofil, Inulin and Ethamolin; is preparing to launch two proprietary, extended-release wound-care products; and, is developing its two lead drugs, Cordox and Ceresine, for a variety of ischemic disorders.
This news release contains forward-looking statements which involve risks and uncertainties. Such statements are subject to certain factors which may cause the Company's plans to differ. Factors that may cause such differences include, but are not limited to, the risks discussed in the Company's Form 10-K for the fiscal year ended July 31, 1997 and the Risk Factors section of the Company's Registration Statement No. 333-25661.
Contact:
Annie Truncale,Director of Media Relations
407/682-2001; or [email protected]
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