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BIOTIME BEGINS EUROPEAN HEXTEND CLINICAL TRIALS
BERKELEY, CA July 17, 1997 -- BioTime, Inc. (BTIM - NASDAQ) announced that it
has begun clinical trials of Hextend, its proprietary blood plasma volume
expander, using human volunteers at Middlesex Hospital in London, England.
The study is expected to be completed this quarter. The results will be used
in the design of multinational trials aimed at expanding indications for the
use of Hextend and obtaining regulatory approval in Europe.
Hextend is currently in Phase III clinical trials in the United States, and
is being used in these trials to replace blood volume during surgery in which
substantial amounts of blood are lost. These double-blinded, randomized
trials, expected to include 120 patients, are nearly three-quarters complete.
Quantities of test solution ranging from 0.5 to 5 liters per patient have
been used, and no serious related adverse events have been reported.
"One significant aspect of the current Phase III trials is that they were
designed to exclude the use of albumin," said Dr. Paul Segall, BioTime
President and CEO. "Recent shortages of albumin, plagued by contamination
problems, have caused price increases and concern over its scarcity at
hospital pharmacies."
BioTime, headquartered in Berkeley, California, 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 clinical trials of Hextend, 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.
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