LifeCell Announces Positive Results of ThromboSol In Vitro Platelet Study; Second Physician-Sponsored IND Cleared By FDA.THE WOODLANDS, Texas--(Business Wire)--March 27, 1998--LifeCell Corporation (Nasdaq:LIFC) today announced the results of an in vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment. in vi·tro adj. In an artificial environment outside a living organism. study of LifeCell's ThromboSol(tm) platelet storage solution. Platelets stored in ThromboSol and transfusable concentrations of a cryoprotectant cry·o·pro·tec·tant n. A substance used to protect cells or tissues from damage during freezing. cry maintained statistically higher retention of functionality than standard procedures for storing frozen platelets. The study was published in the recent issue of "Transfusion," the journal of the American Association of Blood Banks. "This in vitro study indicates that ThromboSol can potentially increase the safety and facilitate inventory management of transfusable platelets by enabling extended storage," commented Stephen Livesey, M.D., Ph.D, LifeCell's executive vice president and chief science officer. "The University of Texas M.D. Anderson Cancer Center is currently conducting a pilot clinical study using ThromboSol to stabilize frozen platelets. Additionally, M.D. Anderson Cancer Center recently received 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. clearance for a second physician-sponsored Investigational New Drug pilot clinical study using ThromboSol to stabilize refrigerated platelets. These studies are designed to confirm in human trials the in vitro results published in 'Transfusion'." 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. Unlike red blood cells Red blood cells Cells that carry hemoglobin (the molecule that transports oxygen) and help remove wastes from tissues throughout the body. Mentioned in: Bone Marrow Transplantation red blood cells , platelets must be stored at room temperature because 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. Due to the risk of bacterial contamination at room temperature, the FDA has restricted platelet storage to five days. Techniques for freezing platelets are not currently used because of the complex procedures required to prepare the platelets for transfusion upon thawing. As a result of these current storage limitations, approximately 20 percent of platelet units must be discarded each year. ThromboSol stabilizes platelets to allow refrigerated or long-term frozen storage, thereby overcoming both problems of storage limitation and infection risk. In the published in vitro study, fresh, single-donor platelet units were divided into three samples and each treated with either the standard concentration of a cryoprotectant solution, 6 percent dimethyl sulfoxide dimethyl sulfoxide (DMSO) Colourless, nearly odourless liquid organic compound. It mixes in all proportions with water, ethanol, and most organic solvents and dissolves a wide variety of compounds (but not aliphatic hydrocarbons). (DMSO DMSO dimethyl sulfoxide. DMSO n. Dimethyl sulfoxide; a colorless hygroscopic liquid obtained from lignin, used as a penetrant to convey medications into the tissues. DMSO, n. ); a lower, 2 percent, concentration of DMSO; or ThromboSol and the 2 percent concentration of DMSO. The higher, 6 percent concentrations of DMSO are toxic and can not be directly transfused without separate processing steps. The lower, 2 percent concentration of DMSO, has the potential to be directly transfusable, but the concentration is too low to maintain the viability of platelets during frozen storage. The objective of the study was to determine whether ThromboSol would maintain the viability of platelets stored frozen in the lower concentrations of the cryoprotectant. The samples were frozen and stored for one week, after which they were thawed and analyzed for in vitro functionality. Platelets cryopreserved with ThromboSol and 2 percent DMSO displayed statistically higher retention of in vitro functional activity than did platelets stored using 6 percent DMSO. Functionality was measured using in vitro indices including surviving cell number, percent of discoid discoid /dis·coid/ (dis´koid) 1. disk-shaped. 2. a dental instrument with a disklike or circular blade. 3. a disk-shaped dental excavator designed to remove the carious dentin of a decayed tooth. cells, extent of shape change, hypotonic hypotonic /hy·po·ton·ic/ (-ton´ik) 1. denoting decreased tone or tension. 2. denoting a solution having less osmotic pressure than one with which it is compared. shock response and expression of activation markers. Additionally, the ThromboSol stored platelets compared favorably to fresh platelets, with no loss in cell number and greater than 75 percent retention of in vitro indices of functionality. LifeCell Corporation is a bioengineering 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 plans 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 are 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 product development and 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 Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended Dec. 31, 1997. CONTACT: LifeCell Corporation, The Woodlands J. Donald Payne, 281/367-5368 http://www.lifecell.com |
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