Phase II Trial of ProMetic's PBI-1402 Shows Significantly Increased
Red Blood Cell Count and Hemoglobin in Chemotherapy-Induced Anemia
Patients
Trial Results Announced At American Society of Hematology 49th Annual
Meeting
MONTREAL, QUEBEC--(Marketwire - December 10, 2007) - ProMetic Life
Sciences Inc. (TSX: PLI) ("ProMetic") announces that a Phase II trial
of its investigational compound PBI-1402 induced a significant
increase in red blood cell count and hemoglobin level in patients
with chemotherapy-induced anemia ("CIA"). Additionally, no
significant adverse events were observed. PBI-1402 is a novel, orally
active low molecular weight synthetic compound with
erythropoiesis-stimulating activity via a mechanism of action
distinct from erythropoietin ("EPO"). These results were presented in
a poster session today at the American Society of Hematology 49th
Annual Meeting in Atlanta.
"We are very encouraged by these results as they demonstrate that a
non-EPO compound may provide significant activity for the treatment
of anemia in CIA patients who have a limited number of treatment
options," said Pierre Laurin, President and CEO of ProMetic. "We
believe these data indicate the tremendous potential for our
compound, and we look forward to continued clinical research with
PBI-1402 in this patient population."
In this open-label Phase II trial, the first two out of three cohorts
of six patients each received PBI-1402 once daily at doses ranging
from 44mg/kg to 66mg/kg. Results of these first 12 patients
demonstrated that 83 percent of patients had a significant increase
in red blood cell count from baseline (p equals 0.015), and 66
percent of patients had a significant increase in hemoglobin (p
equals 0.038). For those who responded to treatment, the mean
increase in hemoglobin level was 1.1g/dL from the baseline value of
9.8g/dL (p equals 0.0007). In non-responders, PBI-1402 stabilized red
blood cell count and hemoglobin level.
No patients required blood transfusion, and only one patient
demonstrated hemoglobin content below 9g/dL (8.9g/dL). PBI-1402 was
generally well tolerated. Only two patients reported side effects
deemed related to PBI-1402. These were of low grade and mainly
involved the gastrointestinal tract.
About PBI-1402
PBI-1402 is an orally active compound being developed to treat
different types of anemia, such as CIA, in which the current clinical
trial has expanded to include an additional 12 patients receiving the
lowest trial dose. ProMetic has recently extended its clinical
program for PBI-1402 into the treatment of anemia in patients with
myelodysplastic syndrome ("MDS"), a condition often referred to as
"pre-leukemia". Clinical trials in patients with anemia associated to
chronic kidney diseases are also scheduled to commence shortly.
About ProMetic Life Sciences Inc.
ProMetic Life Sciences Inc. (www.prometic.com) is a biopharmaceutical
company specialized in the research, development, manufacture and
marketing of a variety of commercial applications derived from its
proprietary Mimetic Ligand (TM) enabling technology. This technology
is used in large-scale purification of biologics and the elimination
of pathogens. ProMetic is also active in therapeutic drug development
with the mission to bring to market effective, innovative, lower
cost, less toxic products for the treatment of hematology and cancer.
Its drug discovery platform is focused on replacing complex,
expensive proteins with synthetic "drug-like" protein mimetics.
Headquartered in Montreal (Canada), ProMetic has R&D facilities in
the UK, the USA and Canada, manufacturing facilities in the UK and
business development activities in the U.S., Europe, Asia and in the
Middle-East.
Forward Looking Statements
This press release contains forward-looking statements about
ProMetic's objectives, strategies and businesses that involve risks
and uncertainties. These statements are "forward-looking" because
they are based on our current expectations about the markets we
operate in and on various estimates and assumptions. Actual events or
results may differ materially from those anticipated in these
forward-looking statements if known or unknown risks affect our
business, or if our estimates or assumptions turn out to be
inaccurate. Such risks and assumptions include, but are not limited
to, ProMetic's ability to develop, manufacture, and successfully
commercialize value-added pharmaceutical products, the availability
of funds and resources to pursue R&D projects, the successful and
timely completion of clinical studies, the ability of ProMetic to
take advantage of business opportunities in the pharmaceutical
industry, uncertainties related to the regulatory process and general
changes in economic conditions. You will find a more detailed
assessment of the risks that could cause actual events or results to
materially differ from our current expectations on page 21 of
ProMetic's Annual Information Form for the year ended December 31,
2006, under the heading "Risk Factors". As a result, we cannot
guarantee that any forward-looking statement will materialize. We
assume no obligation to update any forward-looking statement even if
new information becomes available, as a result of future events or
for any other reason.
Contacts:
Company Inquiries:
ProMetic Life Sciences Inc.
Pierre Laurin
President and CEO
514-341-2115
p.laurin@prometic.com
ProMetic Life Sciences Inc.
Anne Leduc
Manager, Communications
514-341-2115
a.leduc@prometic.com
Echoes Financial Network Inc.
Dominic Sicotte
514-842-9551
dsicotte@echoesfinancial.com
Investor Relations:
Lippert / Heilshorn & Associates
Bruce Voss
310-691-7100
BVoss@lhai.com
Lippert / Heilshorn & Associates
Kim Golodetz
212-838-3777
KGolodetz@lhai.com
Media Relations:
Lippert / Heilshorn & Associates
Jules Abraham
212-838-3777
Jabraham@lhai.com