ProMetic Life Sciences Inc. Oral PBI-1402 Demonstrates Significant Activity in Chemotherapy-Induced Anemia Phase II Clinical Trial
MONTREAL, April 23 /PRNewswire-FirstCall/ - ProMetic Life Sciences Inc. ("ProMetic") announces that oral PBI-1402 demonstrates significant activity in patients with chemotherapy-induced anemia ("CIA"), and reduces the need for red blood cell ("RBC") transfusion.
Only 2 patients out of 28 (7%) treated with PBI-1402 required a RBC transfusion, a response rate greater than 90% with regards to this clinical objective. In the March 13, 2008 FDA briefing document, the Oncologic Drugs Advisory Committee emphasizes that the primary objective of treating CIA patients with erythropoiesis-stimulating agents ("ESAs") as being the ability to reduce the need for RBC transfusion. The Advisory Committee cites that approximately 50% of anemic patients receiving chemotherapy required RBC transfusion, and 20%-25% of patients treated with ESAs still required RBC transfusions.
"These results are very exciting and meet the primary objective that formed the basis for FDA approval of other ESAs in CIA patients," states Mr. Pierre Laurin, President and Chief Executive Officer of ProMetic Life Sciences Inc. "This new encouraging data further supports the potential role PBI-1402 could play in the management of anemia in patients with cancer," added Mr. Laurin.
CIA patients enrolled in the study received a once daily oral dose of PBI-1402 during a period of eight weeks while undergoing their normal course of chemotherapy. All patients enrolled have completed the PBI-1402 treatment period.
About PBI-1402
PBI-1402 is an orally active compound being developed to treat different types of anemia, such as CIA. PBI-1402 has a distinct mechanism of action and does not act through EPO receptor. ProMetic has recently expanded 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". In addition, a new Phase II study in patients with anemia resulting from chronic kidney disease has been scheduled.
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 U.K., U.S. and Canada, manufacturing facilities in the U.K. and business development activities in the U.S., Europe, Asia and 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, unless required by applicable securities laws and regulations.
CONTACT: Company Inquiries: Pierre Laurin, President and CEO, ProMetic
Life Sciences Inc., (514) 341-2115, p.laurin@prometic.com; Anne Leduc,
Manager, Investor Relations & Communications, ProMetic Life Sciences Inc.,
(514) 341-2115, a.leduc@prometic.com; Dominic Sicotte, Echoes Financial
Network Inc., (514) 842-9551, dsicotte@echoesfinancial.com; Media
Relations: Jules Abraham, Lippert/Heilshorn & Associates, (212) 838-3777,
Jabraham@lhai.com