ProMetic reports continued positive data in PBI-1402 phase II trial in chemotherapy-induced anemia- Update on Clinical Developments
MONTREAL, March 06, 2008 /PRNewswire-FirstCall/ - ProMetic Life Sciences Inc. ("ProMetic") announces favorable top-line findings from the third cohort in its Phase II trial with PBI-1402 in patients with chemotherapy-induced anemia ("CIA"). Analysis of the compiled data from a total of 18 patients showed an overall statistically significant increase of the mean hematocrit values at weeks 4, 6 and 8, and of the hemoglobin values at week 8. At week 8, p values were 0.02 for hematocrit and hemoglobin. More detailed results from the study have been submitted to the European Hematology Association for presentation at their June 2008 meeting in Copenhagen.
"These results are very encouraging and continue to demonstrate the efficacy and safety profile of PBI-1402, a non-EPO (erythropoietin) treatment for CIA," states Mr. Pierre Laurin, President and Chief Executive Officer of ProMetic Life Sciences Inc. "We are excited about the prospects for PBI-1402 for the treatment of anemia in oncology since, unlike EPO, PBI-1402 demonstrated some anticancer activity in animal models. We look forward to sharing more detailed clinical trial results."
Other PBI-1402 development highlights include the extension of the enrollment for the PBI-1402 CIA trial to include an additional 12 patients receiving the lowest trial dose. Data from these additional patients are expected by June 2008.
In addition, a new Phase II study in patients with anemia resulting from chronic kidney disease has been scheduled. This multi-center study will be placebo controlled and will examine the effect of PBI-1402 on anemia, as well as several other clinical parameters. Conclusive results obtained recently in animal models have confirmed the erythropoiesis activity of PBI-1402 even when there is little or no endogenous EPO produced by the kidney.
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".
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, ProMeticLife Sciences Inc., (514) 341-2115, ; Dominic Sicotte,Echoes Financial Network Inc., (514) 842-9551,; Anne Leduc, Manager, Investor Relations andCommunications, ProMetic Life Sciences Inc., (514) 341-2115,; Investor Relations: Bruce Voss, Lippert/Heilshorn &Associates, (310) 691-7100, ; Kim Golodetz, Lippert/Heilshorn& Associates, (212) 838-3777, ; Media Relations: JulesAbraham, Lippert/Heilshorn & Associates, (212) 838-3777, firstname.lastname@example.org email@example.com firstname.lastname@example.org BVoss@lhai.com KGolodetz@lhai.com JAbraham@lhai.com
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Posted: March 2008