LifeCell Announces Expansion of Clinical Study of ThromboSol Product; U.S. Navy Will Fund Expansion of Study Conducted at M.D. Anderson Cancer Center.THE WOODLANDS, Texas--(BW HealthWire)--August 4, 1998--LifeCell 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 :LIFC) today announced that the University of Texas M.D. Anderson Cancer Center has expanded its evaluation of LifeCell's ThromboSol(TM) platelet storage solution by commencing a second pilot clinical study under a physician-sponsored Investigational New Drug Application. The Company also announced that the U.S. Navy awarded LifeCell an additional $600,000 in funding for expanded development and testing of ThromboSol, including this second pilot clinical trial. This additional funding brings the total research funding Research funding is a term generally covering any funding for scientific research, in the areas of both "hard" science and technology and social science. The term often connotes funding obtained through a competitive process, in which potential research projects are evaluated and through government agencies for LifeCell's ThromboSol program to $2.0 million. "The first ThromboSol pilot clinical study recently was completed at M.D. Anderson using frozen platelets," stated Stephen Livesey, M.D., Ph.D., LifeCell's Executive Vice President and Chief Science Officer. "The results of this study will be submitted for publication later this year. Based upon the results obtained in the first clinical study, M.D. Anderson has commenced enrollment of healthy patients for the second study using refrigerated re·frig·er·ate tr.v. re·frig·er·at·ed, re·frig·er·at·ing, re·frig·er·ates 1. To cool or chill (a substance). 2. To preserve (food) by chilling. platelets. The costs of this second study, as well as additional animal toxicity studies, will be funded through our new cooperative agreement with the Navy." Platelets are essential cells in human blood that initiate the blood clotting blood clotting, process by which the blood coagulates to form solid masses, or clots. In minor injuries, small oval bodies called platelets, or thrombocytes, tend to collect and form plugs in blood vessel openings. process. Platelet transfusions are required by patients undergoing chemotherapy, trauma patients who have lost significant quantities of blood, and patients with certain platelet-depleting diseases. There are approximately eight million platelet units transfused annually in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . As a result of current storage limitations, approximately 20 percent of platelet units must be discarded each year. The ThromboSol product is designed to extend the shelf life of blood platelets by allowing cold storage. Platelets currently must be stored at room temperature because there are no effective methods of refrigerated or frozen storage. Conventional refrigeration refrigeration, process for drawing heat from substances to lower their temperature, often for purposes of preservation. Refrigeration in its modern, portable form also depends on insulating materials that are thin yet effective. results in a progressive decrease in cellular function, reducing the effectiveness of platelets upon transfusion. Conventional frozen storage techniques generally are not used because these involve complex procedures to prepare the platelets for transfusion upon thawing. The refrigerated version of ThromboSol is designed to stabilize the platelets and maintain their effectiveness during refrigeration. The frozen version of ThromboSol is designed to stabilize platelets during storage and allow direct transfusion direct transfusion n. Transfusion of blood from the donor directly to the recipient. Also called immediate transfusion. upon thawing, simplifying the transfusion process. "We believe ThromboSol will increase the supply of platelets available for transfusion as well as meet a significant clinical need in current blood banking practices," commented Dr. Livesey. "Due to the risk of bacterial contamination at room temperature, the 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. currently has restricted platelet storage to five days. Cold storage of platelets both inhibits the growth of bacteria and reduces the risk of certain other transfusion-related adverse reactions adverse reactions, n.pl unfavorable reactions resulting from administration of a local anesthetic; responsible factors include the drug used, concentration, and route of administration. . ThromboSol is designed to stabilize platelets to allow refrigerated or long-term frozen storage, thereby overcoming both problems of storage limitation and infection risk." LifeCell Corporation is a bioengineering bioengineering Application of engineering principles and equipment to biology and medicine. It includes the development and fabrication of life-support systems for underwater and space exploration, devices for medical treatment (see company engaged in the development and commercialization of tissue regeneration and cell preservation products. LifeCell's first commercial product, AlloDerm(R) acellular acellular /acel·lu·lar/ (a-sel´u-ler) not cellular in structure. a·cel·lu·lar adj. 1. Containing no cells; not made of cells. 2. Devoid of cells; noncellular. dermal graft dermal graft n. A skin graft made with a thin split-thickness graft of dermis. , is used in reconstructive plastic, dental and burn surgery. In addition to AlloDerm grafts, the Company's current tissue graft development programs include the LifeCell(R) heart valve, vascular grafts and nerve connective tissue. LifeCell's product development programs also include ThromboSol(TM), a formulation for extending the shelf life of transfusable platelets. For additional information about the company, visit LifeCell's web site at http://www.lifecell.com. Certain of the statements contained in this news release may be deemed to be forward-looking statements. While these statements reflect the Company's current beliefs, they are subject to uncertainties and risks that could cause actual results to differ materially. These factors include, but are not limited to, the uncertainty of the outcome of clinical trials, the uncertainty of patent protection, the demand for the Company's products and services, economic and competitive conditions and products and other risks detailed in the Company's Annual Report on Form 10-K/A for the year ended December 31, 1997.
CONTACT: LifeCell Corporation, The Woodlands
Rebecca Elliott, 281/367-5368
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