Cypros Pharmaceutical Receives Notice of Allowance On Key U.S. Patent Covering Cordox Use in Bypass Surgery.CARLSBAD, Calif.--(BUSINESS WIRE)--June 15, 1999-- Company Designing Pivotal Phase III Protocol for Discussion With 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. Cypros Pharmaceutical Corp. (AMEX AMEX See: American Stock Exchange :CYP CYP In currencies, this is the abbreviation for the Cyprus Pound. Notes: The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion. ) announced today that it had received a notice of allowance from the U.S. Patent and Trademark Office on a patent covering the use of its cardioprotective drug Cordox(TM) to reduce the complications associated with all forms of cardiac bypass surgery Bypass surgery A surgical procedure that grafts blood vessels onto arteries to reroute the blood flow around blockages in the arteries (arteriosclerosis). . This patent is the second bypass surgery case allowed within the past two months and establishes the company's proprietary position for the use of Cordox(TM) in this major cardiothoracic surgery indication. There are almost one million cardiac surgeries performed per year in the U.S. that involve heart bypass, and there are currently no drugs approved to protect the heart during the prolonged 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 period encountered during cardiopulmonary bypass cardiopulmonary bypass n. A procedure to circulate and oxygenate the blood during heart surgery involving the diversion of blood from the heart and lungs through a heart-lung machine and the return of oxygenated blood to the aorta. . Major complications from bypass surgery can include myocardial infarction myocardial infarction: see under infarction. , heart failure, significant cardiac arrhythmias, stroke, pulmonary failure, renal failure renal failure n. Acute or chronic malfunction of the kidneys resulting from any of a number of causes, including infection, trauma, toxins, hemodynamic abnormalities, and autoimmune disease, and often resulting in systemic symptoms, especially edema, , liver failure liver failure Clinical medicine Liver insufficiency that results in death, requires a liver transplant, or is characterized by recovery after encephalopathy, or while awaiting a transplant; also defined as a condition with ≥ 3 of following: albumin < 3. , and death, especially in the high-risk patients which the company is targeting with Cordox(TM). Cordox(TM) is a naturally occurring high energy intermediate of cellular energy metabolism with demonstrated cardioprotective effects in both pre-clinical and clinical studies. Cypros has evaluated Cordox(TM) in over 300 patients in various placebo controlled, double blind cardiovascular Phase II clinical trials (125 in bypass surgery). Results to date have shown dose dependent statistically significant reductions in heart tissue damage during surgery, improvements in heart function after surgery and protection of pulmonary blood vessels. Reduced intensive care unit and hospital stays were also noted in the optimal dosing regimens. The company has designed a pivotal trial in bypass surgery patients that are at high risk of complications, which it will discuss with the FDA at a planned meeting this summer. The trial is designed to demonstrate the benefit of Cordox(TM) in reducing the complications of surgery in high-risk patients. Cordox(TM) is also being evaluated in a multi-center Phase III trial in sickle cell anemia sickle cell anemia n. A chronic, usually fatal inherited form of anemia marked by crescent-shaped red blood cells, occurring almost exclusively in Blacks, and characterized by fever, leg ulcers, jaundice, and episodic pain in the joints. crisis patients. Commenting on the announcement, Paul J. Marangos, chairman and chief executive officer of Cypros, stated, "We are excited about the prospects of Cordox(TM) as a cardioprotective agent in bypass surgery. We have generated a substantial body of data in this indication, which supports previous published clinical studies, and are excited about the Phase III protocol we are currently designing. We are pleased to now have ownership of this second late stage opportunity (in addition to sickle cell anemia) with Cordox(TM), and believe it adds substantial value to the company and justifies moving forward in this indication. Our less than adequate past patent protection in bypass surgery has now been remedied and this should improve our ability to move forward with this attractive market opportunity." Cypros Pharmaceutical is engaged in the development and marketing of drugs for the acute care hospital, wound and burn care markets. The company currently has three products on the market: Glofil, Inulin inulin /in·u·lin/ (in´ul-in) a starch occurring in the rhizome of certain plants, yielding fructose on hydrolysis, and used in tests of renal function. in·u·lin n. , Ethamolin(R) and a Dermaflo(TM) product, is preparing to launch two proprietary, extended-release wound-care products using the Dermaflo(TM) technology; and, is developing its two lead drugs, Cordox(TM) and Ceresine(TM), for a variety of ischemic disorders. Visit the Cypros Pharmaceutical Web site at http://www.Cypros.com for more detailed information on Cordox(TM). 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, 1998 and the Risk Factors section of the company's Registration Statement No. 333-25661. |
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