ProMetic Life Sciences Inc.

ProMetic Life Sciences Inc.

September 12, 2007 06:00 ET

ProMetic Expands Indication for PBI-1402 Into Anemia In Cancer Patients

- Favorable interim data in current CIA trial supports PBI-1402 expansion in cancer-related anemia - Initiation of a Phase II trial for treatment of anemia in patients with pre-leukemia

MONTREAL, QUEBEC--(Marketwire - Sept. 12, 2007) - 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

About ProMetic Life Sciences Inc.

ProMetic Life Sciences Inc. ( is a biopharmaceutical company specialized in the research, development, manufacture and marketing of a variety of commercial applications derived from its proprietary Mimetic Ligand™ 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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