New Phase 2 Data for Non-EPO Treatment of Anemia
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, CANADA (December 9, 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=0.015), and 66 percent of patients had a significant increase in hemoglobin (p=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=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
Montréal (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.
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For further information please contact:
Company Inquiries
Pierre Laurin Dominic
Sicotte
President and CEO Echoes
Financial Network Inc.
ProMetic Life Sciences Inc. dsicotte@echoesfinancial.com
p.laurin@prometic.com
+1.514.842.9551
+1.514.341.2115
Anne Leduc
Manager, Communications
ProMetic Life Sciences Inc.
a.leduc@prometic.com
+1.514.341.2115
Investor Relations
Bruce Voss Kim Golodetz
Lippert / Heilshorn & Associates Lippert / Heilshorn &
Associates
BVoss@lhai.com KGolodetz@lhai.com
+1.310.691.7100 +1.212.838.3777
Media Relations
Jules Abraham
Lippert / Heilshorn & Associates
Jabraham@lhai.com
+1.212.838.3777
Posted: December 2007
