Hemosol Receives FDA Approval to
Begin US Trial of Hemolink(TM) in
Patients Undergoing Coronary
Artery Bypass Surgery
August 25, 1998
TORONTO, Aug. 24 /PRNewswire/ via NewsEdge Corporation -- Hemosol
Inc. (TSE: HML), a Toronto-based biotechnology company, today
announced that it has received clearance from the US Food and Drug
Administration (FDA) to begin Phase II clinical trials of its human blood
substitute product, Hemolink(TM), in patients undergoing coronary artery
bypass grafting surgery (CABG).
Hemolink(TM) will be used as a red blood cell substitute to conserve the
patient's own blood and reduce exposure to allogeneic, or donated blood. The
study will also determine whether Hemolink(TM) will lessen potential adverse
effects associated with CABG surgery, such as bleeding disorders, blood
pressure instability and central nervous system effects. Sixty patients will be
enrolled, half of whom will receive up to 1000 ml of Hemolink(TM), while the
other half will receive a colloid solution, an established treatment option. The
study will be randomized and conducted in four treatment blocks.
"Our initiation of Hemolink(TM) in this second set of US clinical trials is an
important aspect of our strategic plan: to secure a strong market position in
North America, including a percentage of the growing US CABG market,"
stated John Kennedy, President and CEO of Hemosol Inc. " This, our second
bypass surgery trial and sixth trial overall, is further evidence of the broad
potential application for Hemolink(TM)."
Hemolink(TM) is currently in four Phase II clinical trials. These include a
CABG study in Canada and the United Kingdom, trials in the US and Canada
focused on treatment of patients with anemia associated with chronic renal
failure, and an orthopedic study underway in the United Kingdom. The initial
orthopedic trial was completed in Canada with positive results.
CABG is one of the most common surgical procedures undertaken in North
America. According to the American Heart Association, nearly 590,000
surgeries were reported in North America in 1995, the most recent year for
which statistics are available. CABG bypass surgery involves re-routing blood
around clogged arteries to improve the supply of blood and oxygen to the
heart. A cardiopulmonary bypass pump is usually employed to circulate the
patient's own blood during the operation.
Hemosol is a Canadian biopharmaceutical company developing a
multi-product pipeline based on proprietary technologies in the field of blood
cells and proteins. Its major focus is in the development and successful
commercialization of blood substitute products derived from human
hemoglobin. Additionally, with its stem cell expansion technologies, Hemosol is
developing new sources for human hemoglobin as well as novel cell therapies
for HIV/AIDS and cancer.
The information contained in this release includes forward-looking statements
that are subject to risks and uncertainties that could cause actual results to
differ materially, including the uncertainties associated with the conduct of
clinical trials.
SOURCE Hemosol, Inc.
/CONTACT: John W. Kennedy, President & CEO of Hemosol Inc.,
416-798-0700; or Kate Banks, Director of Clinical Trials US,
781-829-9993; Investor Relations - Jason Hogan,
jhogan@equicomgroup.com or Geoff Kistruck, both of Equicom Group,
416-815-0700, ext.222; or Juliane Snowden, investors, or Susan Farley,
media, sfarley@dewerogerson.com, both of Dewe Rogerson Inc.,
212-688-6840/
[Copyright 1998, PR Newswire] |
