Cytel Corporation Initiates Clinical Registration Trials of Cylexin.SAN DIEGO--(BW HealthWire)--Dec. 18, 1997--Cytel Corporation (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 :CYTL) today announced initiation of clinical registration trials of Cylexin(TM) for the prevention of reperfusion injury reperfusion injury damage to renal blood vessels during periods of hypotension does not become apparent until reperfusion occurs in the recovery stage of the vascular incident. in infants undergoing hypothermic 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. (CPB CPB see cardiopulmonary bypass. CPB Cardiopulmonary bypass. See Port-Access cardiopulmonary bypass. ) during surgical repair of congenital heart defects Congenital heart defects Congenital means conditions which are present at birth. Congenital heart disease includes a variety of defects that babies are born with. Mentioned in: Heart Failure, Heart Surgery for Congenital Defects . The double-blind, placebo controlled study will eventually enroll 250 infants under the age of 45 days. The multicenter trial will be initiated at Boston Children's Hospital, The Cleveland Clinic, and The Los Angeles Children's Hospital and is expected to include seven other leading centers for pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. cardiac surgery in the United States and Canada. It is anticipated that enrollment in the study will be completed by the end of 1998, according to Robert Roe, M.D., Cytel's Executive Vice President and Chief Operating Officer Chief Operating Officer (COO) The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president. . "We are pleased that leaders in infant heart surgery at these centers realize the potential value of Cylexin and have agreed to participate in our clinical trials," Dr. Roe said. "There are, currently, no existing drugs to prevent reperfusion injury in this patient population. We believe that the positive results we've obtained in Phase I/II trials, and the FDA's recent designation of Orphan Drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the Status for Cylexin, demonstrate the Company's leadership position in bringing treatments like this to market." Results from a Phase I/II study of 17 patients completed in September 1997 at Boston Children's Hospital, showed that Cylexin exhibited a good safety profile and improved post-operative recovery of infants following hypothermic CPB surgery. Trial data showed reduction in intubation intubation /in·tu·ba·tion/ (in?too-ba´shun) the insertion of a tube into a body canal or hollow organ, as into the trachea. endotracheal intubation time, reduction in post-operative edema edema (ĭdē`mə), abnormal accumulation of fluid in the body tissues or in the body cavities causing swelling or distention of the affected parts. and shortened hospital stays for patients receiving the highest dose of the drug. There was also a one day (30%) decrease in median ICU ICU intensive care unit. ICU abbr. intensive care unit ICU see intensive care unit. ICU time for the higher dose infant group. "Treatment with Cylexin could potentially reduce morbidity, shorten recovery time of patients and may therefore lead to reduced costs of therapy," said Roe. "The objective of the current trial will be to determine if treatment with Cylexin leads to improved post-operative cardiac, pulmonary, renal, and neurologic function. Many times, these functions are adversely effected by reperfusion injury following open heart surgery." Approximately 20,000 infants undergo open heart surgery requiring CPB to correct congenital heart defects each year in North America. Following this surgery, it is common for infants to experience long recovery times and sometimes death due in part to reperfusion injury. Reperfusion injury is an acute inflammatory cascade that occurs when blood supply to tissues is cut off and then restored, such as occurs in CPB. In this process, white blood cells White blood cells A group of several cell types that occur in the bloodstream and are essential for a properly functioning immune system. Mentioned in: Abscess Incision & Drainage, Bone Marrow Transplantation, Complement Deficiencies first adhere to and then migrate through blood vessel walls, releasing enzymes that cause damage to the surrounding tissues. Cylexin is designed to block white cell adhesion, the earliest step in the process, thereby reducing inflammation during the critical post-operative period. Cytel is a leader in the discovery and development of cell adhesion inhibitors for treatment of acute and chronic inflammation, and its Glytec unit is a leader in the manufacture of bioactive carbohydrates for use in pharmaceutical and consumer products. Epimmune Inc., its subsidiary, is focused on the discovery and development of a new generation of safer, more potent vaccines for the prevention and treatment of cancer and infectious diseases. This press release includes forward-looking statements that reflect management's current views of future events. Actual results may differ materially from the above forward-looking statements due to a number of important factors, including but not limited to the risks associated with successfully negotiating and completing definitive agreements for any corporate collaboration, the timing and cost of conducting human clinical trials, the regulatory approval process, and the possibility that testing may reveal undesirable and unintended side effects or other characteristics that may prevent or limit the commercial use of proposed products. These factors are more fully discussed in Cytel's most recent Forms 10-K and 10-Q. CONTACT: Cytel Corporation Robert Roe, M.D., 619/552-3000 or Mentus, Inc. Linda Seaton, 619/455-5500 ext. 133 (media) Virginia Rybski, 619/455-5500 ext. 113 (investors) |
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