ProMetic Receives Authorization From Health Canada to Initiate Phase IB/II Clinical Trial for Anemia Drug PBI-1402, Mechanism of Action of PBI-1402 Revealed.MONTREAL -- ProMetic BioSciences Inc., the therapeutic unit of ProMetic Life Sciences Inc. (TSX TSX Toronto Stock Exchange (TSE before April, 2002) TSX Transfer from Stack Pointer to Index TSX True Space Extension :PLI PLI Practising Law Institute PLI Professional Liability Insurance PLI Programming Language Interface (Verilog programming language) PLI Partido Liberal Independiente (Independent Liberal Party, Nicaragua) .SV), announced today that it has received authorization from the Therapeutic Products Directorate Therapeutic Products Directorate (TPD) is a Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use, a role performed by the Food and Drug Administration in the United States. of Health Canada Health Canada (French: Santé Canada) is the department of the government of Canada with responsibility for national public health. Health Canada's goal is to improve Canadian life by improving Canadian longevity, lifestyle and use of public healthcare. to begin a Phase Ib/II clinical trial of PBI-1402, its novel therapeutic compound in development to treat patients with anemia. The Company plans to study the safety and efficacy of PBI-1402 in up to 30 cancer patients undergoing chemotherapy and suffering from anemia. This clinical trial will be undertaken at Maisonneuve-Rosemont Hospital, in Montreal, under the supervision of Drs. Denis-Claude Roy (hematologist he·ma·tol·o·gist n. A physician specializing in hematology. Hematologist A medical specialist who treats diseases and disorders of the blood and blood-forming organs. ) and Julie Beaudet (oncologist). "Following the results obtained during the phase I trial, displaying an excellent safety profile and an increase of reticulocyte reticulocyte /re·tic·u·lo·cyte/ (re-tik´u-lo-sit) a young erythrocyte showing a basophilic reticulum under vital staining. re·tic·u·lo·cyte n. numbers, we are very excited to initiate this phase Ib/II study in chemotherapy-treated patients", said Dr. Denis-Claude Roy. In addition, the Company is pleased to announce that the scientists at ProMetic BioSciences Inc. have made significant progress towards the elucidation of the mechanism of action of PBI-1402. This important step will support future clinical development strategies for this candidate drug. The mechanism of action of PBI-1402 is different from the current drug of choice for the treatment of anemia, erythropoietin erythropoietin /eryth·ro·poi·e·tin/ (-poi´e-tin) a glycoprotein hormone secreted by the kidney in the adult and by the liver in the fetus, which acts on stem cells of the bone marrow to stimulate red blood cell production (EPO EPO see erythropoietin. EPO Erythropoietin, see there ). As such, PBI-1402 offers the potential to treat anemic patients who are not responsive to EPO.Furthermore, since PBI-1402 has shown an additive effect additive effect n. An effect in which two substances or actions used in combination produce a total effect the same as the sum of the individual effects. in combination with EPO on human progenitor cell proliferation in vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment. in vi·tro adj. In an artificial environment outside a living organism. , it could be used in monotherapy and/or in combination with EPO. About ProMetic Life Sciences 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 mimetic /mi·met·ic/ (mi-met´ik) pertaining to or exhibiting imitation or simulation, as of one disease for another. mi·met·ic adj. 1. Of or exhibiting mimicry. 2. 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 inflammation 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 and manufacturing facilities in the UK and business development activities in the US, Europe, Asia and countries in the Middle East and North Africa. Additional information is available on the Company's website at www.prometic.com. 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 15 of the Company's Annual Information Form for the year ended December 31, 2004, 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. ProMetic Life Sciences Inc. (TSX:PLI.SV) |
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