BIOTIME TO BEGIN CLINICAL STUDIES OF PENTALYTE, A NEW BLOOD PLASMA VOLUME EXPANDER
BERKELEY, CA, APRIL 18, 2000--BioTime, Inc. (BTX - -AMEX) announced today that it has received permission from the FDA to begin a Phase I clinical trial of PentaLyte® involving nine subjects. PentaLyte is a proprietary pentastarch-based, physiologically balanced blood plasma volume expander designed to replace blood volume in a variety of surgical applications.
PentaLyte is the second in BioTime's family of products to enter clinical trials. Upon completion of this small safety study, BioTime plans to test PentaLyte in surgical procedures. PentaLyte contains a lower molecular weight hydroxyethyl starch than Hextend®, BioTime's lead product. PentaLyte is more quickly metabolized than Hextend, and is designed for use when short lasting volume expansion is desirable. ``With both PentaLyte and Hextend, BioTime can look forward to more completely addressing the substantial market for blood plasma volume expansion,'' said Dr. Paul Segall, BioTime's Chairman and CEO. Hextend, a plasma volume expander designed to replace large volumes of blood often lost during major surgery, is commercially available in the United States. Hextend has been submitted for approval in Canada. Chemistry, manufacturing, and control data are being compiled to complete the requirements to file for European approval. BioTime, headquartered in Berkeley, California, is engaged in the research and development of blood plasma volume expanders, blood replacement solutions during hypothermic (low temperature) surgery, organ preservation solutions and technology for use in surgery, emergency trauma treatment, the preservation of organs awaiting transplant, and other applications.
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 products; BioTime's ability to negotiate favorable foreign 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.
Contact:
BioTime, Inc.
Victoria Bellport, 510/845-9535