Prometic reports positive preliminary Phase Ib/II data for PBI-1402 in chemotherapy-induced anemia
- Category: Small Molecules
- Published on Thursday, 12 July 2007 04:00
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MONTREAL, Canada | July 10, 2007 | ProMetic Life Sciences Inc. (TSX:PLI) (“ProMetic”) announces preliminary data from a Phase Ib/II trial with its orally active drug PBI-1402 for the treatment of chemotherapy-induced anemia (CIA). Data highlights include:
-- Clinical activity confirmed in CIA, a condition associated with a significant rate (e.g., 40-50 percent) of non-response to recombinant erythropoietin (rhEPO);
-- Two-thirds of patients enrolled in the study increased their hemoglobin levels by an average of 14g/L of blood and one-third of patients maintained their hemoglobin levels;
-- All patients enrolled with low levels of white blood cells (neutrophils) achieved improved levels during treatment, while patients with normal neutrophil levels remained unchanged;
-- PBI-1402 was well tolerated by all patients with no serious side effects reported;
-- No patient required a blood transfusion, which is common with CIA;
-- A therapeutic dose was identified for future trials in Europe and in North America.
This Phase Ib/II trial is being conducted in Eastern Europe under the supervision of Pharm-Olam International Ltd., a U.S.-based clinical research organization. Based on these preliminary results, ProMetic has concluded that PBI-1402 is a good candidate for further clinical development, and will focus its work in CIA and anemia related to cancer.
Patients recruited into this trial were anemic as a result of chemotherapy, and their chemotherapy treatment continued throughout the duration of the trial. Increasing the level of hemoglobin and avoiding blood transfusions were considered to be clinically significant outcomes. Notably, to date PBI-1402 increased the level of hemoglobin by an average of 14 g/ L in two thirds of patients, and no patient required a transfusion. In this trial PBI-1402 is being tested as a monotherapy, with no patient receiving rhEPO.
Pierre Laurin, President and Chief Executive Officer of ProMetic, commented: “This positive data is very significant for several reasons. First, it supports our belief that PBI-1402 can potentially provide a great deal of value to patients who suffer from CIA. This encourages us to focus on this patient population, which is known as being very challenging to treat. In addition, from this data we have determined a dosage that we may use in the expansion of our European trial and forthcoming trials in the U.S. and Canada. Finally, based on our preclinical data that show PBI-1402 has an additive effect with rhEPO, and the fact that these two drugs have different mechanisms of action, we anticipate that a combination of PBI-1402 and rhEPO either will improve clinical outcomes, or will maintain clinical efficacy with lower doses of rhEPO than those currently being administered.”
“The effect on neutropenia is also very exciting and is consistent with what we have previously observed in animal models.” said Dr Christopher Penney, Vice-President and Chief Scientific Officer of ProMetic. “This warrants further investigation.”
CIA Phase Ib/II Trial Design and Expansion
The current trial in Eastern Europe was designed to monitor the safety, tolerability and efficacy of PBI-1402 in patients undergoing chemotherapy who developed anemia. The trial design included three cohorts of six patients each at three different doses, with patients in each cohort receiving a single daily dose of PBI-1402 for a period of eight weeks followed by a washout period of eight weeks. The Company has filed for an expansion of this trial. This will allow for additional patient recruitment under the same treatment protocol, but at a dose that will have been determined to be optimal. To date, the positive results reported have been observed in patients receiving the lowest dose allowed in the protocol. The end parameters of hemoglobin, red blood cells and neutrophils are compared against each patient’s baseline level at entry, as well as against levels post-treatment during the washout period.
Chemotherapy-induced Anemia (CIA)
Anemia is one of the most serious side effects caused by chemotherapy. Anemia is a condition in which red blood cells and hemoglobin are below normal levels. CIA is associated with a reduced quality of life and possible compromised treatment outcomes. Of the estimated 1.3 million new patients that undergo chemotherapy annually in the U.S., approximately two third of these patients will develop CIA. Certain types of chemotherapy regimens are associated with more frequent and severe anemia often leading to the patients requiring blood transfusions. The treatment with rhEPO is active in only 50-60 percent of CIA patients. Typical doses of rhEPO required to treat CIA patients is two- to three-fold higher than those used to treat anemia in dialysis patients.
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™ 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 Montréal (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.
SOURCE: ProMetic Life Sciences Inc.