BioTime files Phase III Investigational New Drug Application for Hextend.

BERKELEY, Calif.--(BUSINESS WIRE)--March 1, 1996--BioTime Inc. (NASDAQ:BTIM) Friday announced that it has filed an Investigational New Drug (IND) Application with the Food and Drug Administration requesting permission to initiate Phase III clinical trials for Hextend, a proprietary plasma volume expander.

Hextend is formulated to minimize physiological imbalances when large quantities of solution are infused into patients to replace blood volume lost during surgery.

The clinical trials are designed to test whether the use of Hextend during major elective surgeries such as orthopedic, urologic and gastrointestinal procedures can prevent hypovolemia and maintain organ perfusion, thus improving patient outcome.

Extensive blood loss during these surgeries commonly causes hypovolemia, a condition that results when there is not enough circulation of fluid to adequately support all the tissues of the body. When hypovolemia occurs, blood flow to organs such as the gastrointestinal tract, liver and kidneys diminishes, resulting in damage to these organs.

BioTime plans to use Hextend in these studies in volumes as needed to prevent hypovolemia. It is anticipated that such use of Hextend will result in improved organ blood flow, and therefore reduce postoperative illness. This should translate into healthier patients, shorter periods of intensive care and hospital stays, and lower hospital costs.

Following appropriate regulatory and institutional review, these clinical trials are expected to begin at the Duke University Medical Center in Durham, N.C. Dr. Paul Segall, president and chief executive officer of BioTime, stated, "These trials would be the first of a series which BioTime will conduct to assess the safety and efficacy of Hextend in a number of surgical procedures in which Hextend's unique properties may be of benefit."

Additional studies are being designed to assess the value of Hextend as a priming solution in cardiopulmonary bypass, in extending the duration and improving the outcome of low-temperature cardiovascular and neurologic surgeries, and in harvesting and transporting organs for transplantation.

BioTime, with headquarters in Berkeley, is engaged in the research and development of synthetic plasma 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