BioTime Announces Completion of Hextend Phase III Clinical Trials.

BERKELEY, Calif.--(BW HealthWire)--Dec. 8, 1997--BioTime, Inc. (NASDAQ:BTIM) announced that it has unblinded its pivotal Phase III clinical trials of Hextend(R), its proprietary blood plasma volume expander.

Up to five (5) liters of Hextend were used to replace blood volume lost in patients undergoing high blood loss surgeries, including orthopedic, gastrointestinal, urologic and gynecological procedures without any serious related adverse events. On average, the Hextend patients received 1.6 liters of solution. None of the patients receiving Hextend were give albumin during surgeries.

The primary end point of the trials is to show Hextend can be used to treat hypovolemia (insufficient fluid in the blood vessels of the body). The double blind randomized study comparing Ilextend(R) (a buffered physiologically balanced solution containing hetastarch, electrolytes and other components) and hetastarch in saline was conducted at Mt. Sinai Medical Center in N.Y. and the Duke University Medical Center in North Carolina and involved 120 patients. The preliminary analysis of the data shows that Hextend prevented hypovolemia as measured by blood pressure, heart rate and urine output.

A comprehensive statistical analysis of the clinical trial data has begun in order to substantiate all of the properties of Hextend based on an evaluation of the primary and secondary endpoints studied in the trials. Details of the trial will be published and presented at conferences, the first of which will be the 16th Annual Symposium Clinical Update in Anesthesiology conference to be held on January 17-24, 1998 in San Juan, Puerto Rico.

"It is very exciting and important that Hextend was used to replace large volumes of blood loss. The preliminary analysis supports pre-clinical findings and suggest that Hextend offers many advantages for the maintenance of intra-vascular volume and organ perfusion," said Dr. Monty Mythen, Dept. of Anaesthesia, University College London Hospital, the clinical trial's chief principal investigator.

"We are extremely pleased with these results which confirm our expectations. BioTime feels that as a result of the Hextend clinical trials, it will be able to significantly expand the market for plasma expanders. Biotime will quickly apply for approval to market Hextend with a New Drug Application which is currently being prepared for submission to the FDA," said Dr. Paul Segall, BioTime's Chief Executive Officer.

BioTime, headquartered in Berkeley, California, is engaged in the research and development of synthetic blood plasma expanders and hypothermic blood substitute solutions and technology for use in surgery, emergency trauma treatment, the preservation of organs awaiting transplant, and for other biomedical applications.

Statements contained herein that are not historical facts may constitute forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those discussed. These factors include complete statistical analysis of clinical trial data. BioTime's ability to obtain FDA and foreign regulatory approval to market Hextend, the availability and terms of additional financing, competition from products manufactured and sold or being developed by other companies, and the price of and demand for any BioTime products that are utimately sold.

CONTACT: BioTime, Inc.

Victoria Bellport, 510/845-9535