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Hemosol Announces Positive Results for Hemolink(TM) In Routine Coronary Artery By-pass Grafting (CABG) Phase III Surgery Trial
TORONTO, June 26 /CNW/ - Hemosol Inc. (TSE: HML) today announced that
Hemolink(TM) safely reduces transfusion of donor red blood cells (RBCs) in
patients undergoing routine CABG surgery. These findings are based on the
results of the Company's randomized, doubled-blinded, controlled Phase III
trial in Canada and the United Kingdom.
The trial had two main purposes: first, to determine if Hemolink(TM)
could be given safely in a large number of patients undergoing routine CABG
surgery; and second, to determine whether the transfusion of donor red blood
cells (RBCs) could be effectively avoided or reduced in patients administered
Hemolink(TM) relative to patients in a control group, in concert with an
effective blood conservation technique known as Intra-operative Autologous
Donation (IAD).
The standard analysis for efficacy of 288 patients proved that 27 per
cent of the control group received a transfusion of donor RBCs compared with
only 17 percent of the Hemolink(TM) group. The reduction of 37 per cent
relative to the control group is statistically significant. (p<0.05)
Based on these positive results the company plans to file its New Drug
Submission (NDS) with the Therapeutic Products Program (TPP) of Health Canada
in July.
"From both a safety and efficacy standpoint, the final results of this
study confirm the significance and clinical relevance of Hemolink(TM) in
routine CABG surgery," commented John W. Kennedy, Hemosol's President and
Chief Executive Officer. "We have achieved another very important milestone.
In our opinion, the results of this study not only have positive implications
for patient care but also on the economics of health care delivery."
The company also noted that the control arm, IAD plus a standard non-
oxygen carrying volume expander, is a more effective blood conservation
practice than that commonly used in routine CABG surgery. In most centers
using standard non-IAD practices, the rate of donor RBC transfusion would be
expected to be in the range of at least 40 per cent. In this context,
Hemolink(TM) plus IAD, at a 17 per cent donor RBC transfusion rate, is a
dramatic improvement over standard practices.
Hemolink(TM) also performed better than the control group in terms of
other clinically important efficacy measures such as the number of donor RBC
units transfused and the time to first donor RBC transfusion. First, in those
patients who required a transfusion of donor RBCs, the Hemolink(TM) treated
group required approximately 20 per cent less donor RBCs than the control
group. Secondly, the median time to first donor RBC transfusion was 14 hours
longer in the Hemolink(TM) group compared with the control group. Finally, the
rate of transfusion of donor platelets, to control bleeding following surgery,
was 62 per cent lower in the Hemolink(TM) treated group relative to the
control group.
As previously reported, the safety of Hemolink(TM) was well demonstrated
in this study. The safety analysis included 299 patients of the "intent to
treat" group. In major body systems, including the cardiovascular, kidney,
liver, pancreas, gastrointestinal and the central nervous system, both the
Hemolink(TM) treated and control groups had very similar incidence of side
effects other than those benign effects associated with the metabolism of
Hemolink(TM). The pattern and number of side effects in both arms of the trial
is consistent with that generally observed in patients undergoing routine CABG
surgery.
The pivotal Phase III CABG surgery trial in the United States will begin
actively treating patients in September, following adjustments based on
experience gained from the Canada/U.K. Phase III study. The company expects
that patient treatment will take up to 12 months to complete, and a New Drug
Application (NDA) will be filed in the second half of 2001 with the U.S. Food
& Drug Administration (FDA).
Further discussion on the positive implications of the Canada/U.K. Phase
III trial including the rate of donor RBC transfusion, reduced use of donor
RBCs, extended time to first transfusion, reduced use of donor platelets and
IAD is available on the company's web site at www.hemosol.com.
Hemosol is an integrated biopharmaceutical company developing a multi-
product pipeline for global markets based on proprietary technologies for use
initially in the treatment of hemoglobin deficiencies.
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