BioTime to optimize Hextend clinical trial protocol.BERKELEY, Calif.--(BUSINESS WIRE)--April 2, 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) announced that the company is in discussion with the Food and Drug Administration for the purpose of modifying its proposed protocol for Phase III clinical trials Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the to increase the likelihood that, upon successful completion, these trials will meet the regulatory requirements Regulatory requirements are part of the process of drug discovery and drug development. Regulatory requirements describe what is necessary for a new drug to be approved for marketing in any particular country. for filing a new drug application for Hextend, BioTime's 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. Dr. Paul Segall, BioTime president and chief executive officer, said that this represents an important opportunity for BioTime. "It provides a chance to optimize optimize - optimisation the protocol to obtain the broadest allowable indication," he said. BioTime, with headquarters in Berkeley, is engaged in the research and development of blood plasma volume expanders and low-temperature blood substitute solutions and technology for use in surgery, emergency trauma treatment and 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 |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion