ProMetic Expands Indication for PBI-1402 Into Anemia In Cancer Patients
12 9월 2007 - 7:00PM
Marketwired Canada
ProMetic Life Sciences Inc. (TSX:PLI) ("ProMetic") announces the expansion of
its clinical program for its orally active drug PBI-1402 for the treatment of
anemia in patients with myelodysplastic syndrome ("MDS"), a condition often
referred to as "pre-leukemia" and diagnosed in 25,000 individuals in North
America annually.
Pierre Laurin, President and Chief Executive Officer of ProMetic, comments, "The
positive preliminary data obtained in our current Phase Ib/II trial for
chemotherapy-induced anemia ("CIA") and PBI-1402's mechanism of action support
its use as a potential alternative for the treatment of anemia in cancer
patients."
The Food and Drug Administration (FDA) clearly states that the primary objective
in treating anemia in cancer patients is to increase gradually the concentration
of hemoglobin to the lowest level sufficient to avoid the need for blood
transfusion (New England Journal of Medicine, June 2007).
"To date, PBI-1402 performs within these new FDA guidelines." Mr. Laurin
continued, "Statistics show that each year in the U.S. over 500,000 cancer
patients develop cancer-related anemia. These same statistics also report that
additionally, there are an estimated 900,000 patients that develop or are at
risk to develop CIA. We believe that a lower cost, orally active drug to treat
anemia would favorably address cost-benefit and logistics of care, allowing for
out-patient management."
"We have initially targeted pre-leukemia patients as only an estimated 20
percent of them respond to recombinant erythropoietin ("rhEPO") with most
patients requiring blood transfusions. We are hopeful that PBI-1402 will improve
on that," said Dr. Christopher Penney, Chief Scientific Officer of ProMetic
BioSciences Inc. ("PBI"), ProMetic's therapeutic division. "We have already
received approval from the Canadian regulatory agency for our Clinical Trial
Application ("CTA") in MDS and plan to commence patient enrollment in September
of this year."
"The mechanism of action of PBI-1402 is distinct from rhEPO and any other drug
currently under development which ultimately exerts its effect directly or
indirectly via the EPO receptor," comments Dr. Lyne Gagnon, Director of Research
and Development, Biology of PBI. "Therefore, we believe PBI-1402 can contribute
significant clinical benefits to a large patient population suffering with
anemia related to cancer and chemotherapy."
Cancer-related anemia and CIA affect over 1.4 million Americans annually and
remain unsatisfied medical conditions. For instance, according to analysts at
Credit Suisse First Boston, ("CSFB") only 40 percent of the estimated 871,000
Americans who developed or are at risk to develop CIA would have received rhEPO
in 2004. CSBF report, "This low overall penetration reflects a high rate of
non-response (40-50 percent), high treatment costs and inconsistent
reimbursement, and safety concerns about potential effect of rhEPO therapy on
tumor growth progression and risk of thrombotic events."
More about Myelodysplastic Syndromes ("MDS")
MDS are a group of diseases in which the production of blood cells by the bone
marrow is disrupted. Often the bone marrow increases production of various blood
cells but because many of them are defective, they are destroyed before they
reach the blood stream. MDS patients are usually diagnosed with anemia,
infection, bruising, and bleeding. The only treatment approach considered to be
potentially curative is a donor stem cell transplant. In all cases supportive
care is of great importance, this includes measures to prevent and to treat
infections and, in most cases, blood transfusions.
For more information on the PBI-1402 chemotherapy-induced anemia clinical trial
please visit ProMetic's newsroom at www.prometic.com.
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)
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 U.K., the U.S. and Canada, manufacturing
facilities in the U.K. and business development activities in the US, 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, the Company'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 the Company
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 the Company'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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