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( BW)(BIOTIME-INC)(BTIM) BioTime files Phase III Investigational
New Drug Application for Hextend®
Business Editors & Medical/Biotechnology Writers
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.
--30--MEW/la* MHU/la
CONTACT: BioTime Inc., Berkeley
Victoria Bellport, 510/845-9535
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