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BioTime Successfully Completes PentaLyte Phase I Clinical Trial; Hextend Used to Treat Hypovolemia in Cold Surgical Procedures.

Business Editors/Health & Medical Writers

BERKELEY, Calif.--(BW HealthWire)--Aug. 30, 2000

BioTime, Inc. (AMEX:BTX) announced today the successful completion of its Phase I clinical trial of PentaLyte(R), BioTime's proprietary physiologically balanced short-acting blood plasma volume expander. Volunteer subjects received infusions of PentaLyte without any serious related adverse events reported. The procedures were conducted at the Duke University Medical Center in Durham, N.C., under the direction of Dr. T.J. Gan.

If the results of this study are acceptable to the Food and Drug Administration, BioTime plans to seek permission to proceed with further clinical tests of PentaLyte as a plasma volume expander in the treatment of hypovolemia (loss of blood volume) during major surgery. Following regulatory approval, PentaLyte will be marketed as complementary to Hextend(R), its proprietary plasma volume expander currently in use in hundreds of major medical centers in the United States.

PentaLyte and Hextend have similar compositions, but differ in the starch molecule which maintains blood pressure. PentaLyte contains pentastarch, a medium molecular weight hydroxyethyl starch that is metabolized and cleared from the blood stream faster than the hydroxyethyl starch used in Hextend and other 6% hetastarch solutions. This difference makes PentaLyte ideal when short-acting plasma volume expansion is desired. Both PentaLyte and Hextend contain lactate, balanced electrolytes and physiological levels of glucose. BioTime's Hextend is presently the only physiologically balanced plasma volume expander on the market.

"We are delighted that our second product is now approaching more advanced clinical testing," said Dr. Paul Segall, BioTime's Chairman and Chief Executive Officer. "When approved, PentaLyte will complement Hextend and allow BioTime to offer a choice of physiologically balanced plasma volume expanders. This broadening of BioTime's product portfolio is designed to capture a greater portion of the domestic plasma expander market, which the company believes exceeds $400,000,000 annually. BioTime also believes that PentaLyte, along with Hextend, will be well-received internationally," Dr. Segall added.

BioTime's low temperature product development program is progressing. Physicians currently use Hextend to treat hypovolemia during aortic aneurysm surgery. In surgeries of this type, patients are often chilled to temperatures cold enough to sufficiently reduce their metabolic rate and oxygen needs to a level that will permit periods of cardiac and circulatory arrest necessary for such vascular repairs.

Evidence from clinical practice indicates that even lower temperatures might be preferred to protect the brain from damage during periods of arrested circulation exceeding 30 minutes. Additionally, recent studies in animals indicate that replacing all the blood at very low temperatures produces better neurological outcomes. Following appropriate clinical trials and regulatory approval, BioTime plans to market Hextend under the trademark "HetaCool(TM)" for blood volume replacement at very low temperatures.

BioTime, headquartered in Berkeley, Calif., develops blood plasma volume expanders, blood replacement solutions for hypothermic (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 BioTime products; BioTime's ability to obtain FDA and foreign regulatory approval to market its products; competition from products manufactured and sold or being developed by other companies; the price of and demand for BioTime's products; BioTime's ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products; the availability of ingredients used in BioTime products; and the availability of reimbursement for the cost of BioTime products (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 filed with the Securities and Exchange Commission.
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Publication:Business Wire
Geographic Code:1USA
Date:Aug 30, 2000
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