BioTime Announces a Phase II Clinical Trial of Hextend(R) in Japan.EMERYVILLE, Calif. -- BioTime, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :BTIM) announced today that a 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 Hextend[R] is being conducted in Japan by Summit Pharmaceuticals International Corporation under their license agreement with BioTime. Summit is co-developing Hextend for the Japanese market with Maruishi Pharmaceutical Co., Ltd. and both Maruishi and Summit have the right to co-market Hextend if regulatory approval is obtained. Summit expects Phase III Noun 1. phase III - 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 FDA clinical studies to commence in 2008. Hextend has been formulated to restore and maintain plasma volume longer than the plasma volume expanders currently marketed in Japan. Summit estimates that there are on average at least 1 million surgery cases per year in Japan that involve the use of plasma volume expanders. Hextend is a physiologically balanced 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, for the treatment of hypovolemia hypovolemia /hy·po·vo·le·mia/ (-vol-em´e-ah) diminished volume of circulating blood in the body.hypovole´mic hy·po·vo·le·mi·a n. See oligemia. . Hextend is being distributed 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. and Canada by Hospira, Inc. and in South Korea by CJ Corp. under exclusive licenses from BioTime. Hospira also has the right to obtain regulatory approval and market Hextend in Latin America and Australia. Summit has a license to develop Hextend in Japan, the People's Republic of China, and Taiwan. BioTime, headquartered in Emeryville, California develops blood plasma volume expanders, blood replacement solutions for hypothermic hy·po·ther·mi·a n. Abnormally low body temperature. [hypo- + Greek therm (low temperature) surgery, organ preservation solutions and technology for use in surgery, emergency trauma treatment, and other applications. Information about BioTime can be found on the web at www.biotimeinc.com. The matters discussed in this press release include forward-looking statements which are subject to various risks, uncertainties and other factors that could cause actual results to differ materially from the results anticipated. Such risks and uncertainties include but are not limited to the results of clinical trials of Hextend([R]), the ability of Summit and Maruishi to obtain regulatory approval to market Hextend([R]) in Japan; competition from products manufactured and sold or being developed by other companies; the price of and demand for Hextend([R]); and the availability of reimbursement for the cost of Hextend([R]) and related treatment from government health administration authorities, private health coverage insurers and other organizations. These and other risk factors are discussed in BioTime'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. filed with the Securities and Exchange Commission. |
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