BioTime's Hextend cleared for Phase III clinical trials.BERKELEY, Calif.--(BUSINESS WIRE)--Aug. 19, 1996--BioTime Inc. (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 :BTIM) Monday announced that its proprietary blood plasma blood plasma n. The yellow or gray-yellow, protein-containing fluid portion of blood in which the blood cells and platelets are normally suspended. volume expander, Hextend, has been cleared by the Food and Drug Administration to enter Phase III clinical trials in the United States. The company said that the trials will be prospective, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , double-blind controlled studies. According to the company, they are designed to show that Hextend can maintain patient blood pressure and other physiological and biochemical measurements at appropriate levels during major surgery in which substantial amounts of blood are generally lost. BioTime said that two separate trials will be conducted. The first is expected to begin at the Duke University Medical Center, and a second soon after at another institution to be announced To be announced (TBA) A contract for the purchase or sale of an MBS to be delivered at an agreed-upon future date but does not include a specified pool number and number of pools or precise amount to be delivered. later. Each trial is expected to involve approximately 75 patients. Study director Dr. Monty Mythen of the Duke University Medical Center's Department of Anesthesiology anesthesiology (ăn'ĭsthē'zēŏl`əjē), branch of medicine concerned primarily with procedures for rendering patients insensitive to pain, and for supporting life systems under the strains of anesthesia and surgery. said, "Hextend is a buffered, balanced electrolyte formulation which, based on preclinical studies preclinical studies, n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research. , is likely to provide better electrolyte and acid-base management." Dr. Paul Segall, BioTime's president and chief executive officer, said that the clearance of Hextend for Phase III trials is a milestone in BioTime's product development program. BioTime, with headquarters in Berkeley, is engaged in the research and development of synthetic blood plasma volume expanders and low-temperature blood substitute solutions and technology for use in surgery, emergency trauma treatment, the preservation of organs awaiting transplant and other applications. CONTACT: BioTime Inc., Berkeley Victoria Bellport, 510/845-9535 or The Spindler Organization Paul Spindler, 213/930-0811 |
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