CYTEL BEGINS PHASE II CLINICAL TRIALS IN INFANTS UNDERGOING HEART SURGERY.SAN DIEGO--(BUSINESS WIRE)--Feb. 18, 1997--Cytel Corporation (Nasdaq:CYTL) today announced that researchers at the Harvard Medical School Harvard Medical School (HMS) is one of the graduate schools of Harvard University. It is a prestigious American medical school located in the Longwood Medical Area of the Mission Hill neighborhood of Boston, Massachusetts. have begun studying the Company's drug candidate Cylexin(TM) as an aid to improving the post operative course of surgery to correct 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 in newborn infants. Cylexin is being evaluated in this Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II for its ability to mitigate 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. that frequently follows 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. used during surgery. Approximately 20,000 infants undergo this surgery annually in North America at an estimated cost of $45,000 per procedure. Successful intervention would reduce morbidity, shorten recovery time, and materially impact the cost of therapy. The clinical trials are being conducted at Children's Hospital, Boston, the largest 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. medical center in the United States and a teaching hospital of the Harvard Medical School. The Cardiovascular Program at Children's Hospital has an international reputation for excellence in clinical care and clinical research advances. Trials are being conducted under the direction of Jane Newburger, M.D., M.P.H., Associate Professor of Pediatrics, Harvard Medical School, Associate Cardiologist in Chief at Children's Hospital and Director of the Clinical Research Service in the Cardiovascular Program, and Dr. John Mayer, Professor of Surgery at Harvard Medical School and Senior Associate in Cardiac Surgery at Children's Hospital, Boston. In preclinical studies preclinical studies, n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research. Dr. Mayer and colleagues administered Cylexin into the coronary arteries Coronary arteries The two main arteries that provide blood to the heart. The coronary arteries surround the heart like a crown, coming out of the aorta, arching down over the top of the heart, and dividing into two branches. of the hearts of lambs before arresting the circulation of the heart. Dr. Mayer reported, "The hearts treated with Cylexin showed much better recovery of contractile contractile /con·trac·tile/ (kon-trak´til) able to contract in response to a suitable stimulus. con·trac·tile adj. Capable of contracting or causing contraction, as a tissue. function than control hearts that did not receive the drug. In additional experiments, Cylexin was administered to the entire circulation of newborn lambs undergoing open heart surgery under conditions similar to those used during cardiac surgery in humans. Compared to control animals, the lambs treated with Cylexin had dramatically better recovery of heart and lung function. These experiments suggest that Cylexin may be effective in reducing injury to blood vessels Blood vessels Tubular channels for blood transport, of which there are three principal types: arteries, capillaries, and veins. Only the larger arteries and veins in the body bear distinct names. and tissues that follows open heart surgery in infants and children undergoing repair of serious congenital heart defects." Two trials are planned. An initial dose ranging trial, which is expected to take approximately 6 months, will evaluate the safety and pharmacokinetics of several different doses of Cylexin, and will provide pilot efficacy data. Immediately following this trial, a single dose regimen will be selected for a double blind placebo controlled trial involving 60 infants. Clinical efficacy endpoints will include indices of cardiac, pulmonary and neurological function. "The predictive data from the preclinical research conducted at Harvard, and the positive clinical data from an earlier Phase II trial in adults undergoing cardiopulmonary bypass during surgery to remove chronic blood clots from the lung, cause us to have high expectations for Cylexin in this indication," stated Robert L. 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. . Cytel Corporation is a leader in the discovery, design and development of immunotherapeutics, drugs which the company believes will be more selective and have fewer side effects than drugs currently on the market. Cytel's core technology platforms consist of the Immune Stimulation Program under which the company is developing therapeutic vaccines for infectious diseases and cancers, the Immune Suppression Program which is based on anti-inflammatory cell adhesion inhibitors, and Glycotechnology--its proprietary SNC SNC St Norbert College (De Pere, Wisconsin) SNC Sistema Nervioso Central SNC Société en Nom Collectif (French: Partnership) SNC Système Nerveux Central (French: central nervous system) Technology enabling the manufacture of large quantities of complex carbohydrates at commercially viable prices. Except for the historical information contained herein, this discussion contains forward-looking statements that involve risks and uncertainties. The Company's actual results could differ materially from those discussed in this press release. Factors that could cause or contribute to such differences include, but are not limited to, successful and timely clinical development of products and the ability to manufacture those products cost effectively, as well as those discussed in the Company's most recent Form 10-K and Form 10-Qs. CONTACT: Cytel Corporation, San Diego Karin Eastham, Vice President and Chief Financial Officer, 619/552-3000 |
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