BERKELEY, Calif.--(BW HealthWire)--March 31, 1998--BioTime, Inc. (NASDAQ:BTIM - news) today announced that it has completed the submission of its New Drug Application (NDA) for Hextend®, BioTime's proprietary blood plasma volume expander.
The chemistry, manufacturing and control data for the NDA was submitted to the U.S. Food and Drug Administration (FDA) during December 1997.
A formal analysis of BioTime's Phase III clinical trials of Hextend® first presented in San Juan, Puerto Rico at the 16th Annual Symposium Clinical Update in Anesthesiology in January 18-24, and then at the 18th International Symposium On Intensive Care and Emergency Medicine in Brussels, Belgium, March 17-20, confirmed that the primary endpoints of the study had been successfully met. Effectiveness of the treatment in meeting the study's primary endpoints was judged by the maintenance of heart rate, blood pressure and urine flow, and by the amount of fluid required to treat loss of blood volume.
Safety was judged by comparing adverse events, blood product utilization, and laboratory parameters in the two study groups. The trial was randomized, double blinded and prospective and consisted of 120 patients equally divided between two centers, the Mt. Sinai Medical Center in New York, and the Duke University Medical Center in Durham, NC. The procedures included urologic, orthopedic gastrointestinal and gynecologic surgery, as well as other forms of general surgery.
An average of 1.6 liters of Hextend® were used in these surgical procedures. There were no serious related adverse events even when Hextend® was used in volumes as high as 2-5 liters, which greatly exceeded the use of currently available plasma volume expanders in domestic clinical medicine.
Among the safety related secondary endpoints targeted in the study included those involving coagulation. The decrease in adverse events related to blood clotting in the Hextend® group compared to controls supports the finding that Hextend® may be safely used in large amounts. Additionally, albumin, which is both scarce and expensive, was not used.
Dr. Paul Segall, BioTime chairman and chief executive officer said that ``The results of these trials highlight Hextend®'s significant market potential. In the U.S. each year, there are approximately 2.5 million surgeries where blood is transfused. Prior to transfusion, most patients lose several units of blood that need to be replaced by blood products or other intravenous fluids in order to maintain blood pressure and volume. The fact that our surgical goals were safely met with large volumes of Hextend® indicates that substantial amounts of Hextend® could be used for that purpose in each major surgery.''
Dr. Segall also commented that these trials have stimulated interest in Hextend® around the world, and that BioTime is in discussions with a number of internationally-based pharmaceutical companies for licenses to market Hextend® and other BioTime products overseas.
BioTime, headquartered in Berkeley, is engaged in the research and development of synthetic blood plasma extenders 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 the results of any further clinicals trials of Hextend® that may be conducted, BioTime's ability to obtain FDA and foreign regulatory approval to market Hextend®, competition from products manufactured and sold or being developed by other companies, and the price of and demand for any BioTime products that are ultimately sold.
Contact:
BioTime, Inc.
Victoria Bellport, 510/845-9535