Monday June 12, 8:28 am Eastern Time
SOURCE: Hemosol Inc.
Hemosol Announces Preliminary Phase III Study Results for Hemolink(TM) in Cardiac Bypass Patients
TORONTO, June 12 /CNW/ - Hemosol Inc. (TSE: HML - news) today announced preliminary results from its recently completed Canada/United Kingdom Phase III coronary artery by-pass grafting (CABG) study.
The company said that the results confirmed that Hemolink(TM) was safe in cardiac surgery patients and provided high rates of avoidance of transfusion of donor red blood cells (RBCs). However, a high rate of transfusion avoidance was also observed in the control group. Consequently, further in-depth analysis must be completed before definitive conclusions about the relative efficacy, the difference in transfusion avoidance between the two groups, can be made. The Canadian filing will not occur until the analysis is complete which is expected to take approximately four weeks.
The primary safety endpoints of the study were clearly and definitively achieved. Hemolink(TM) was well tolerated by patients. Furthermore no clinically limiting side-effects were observed in patients receiving Hemolink(TM) relative to those in the control group.
While the primary efficacy endpoint of transfusion avoidance will not be determined until further analysis is complete, there were clinically relevant secondary outcomes which favoured Hemolink(TM). These include a reduction in the number of units of donor RBCs used in those patients receiving a transfusion and a longer overall time required to transfusion.
"We remain confident and fully committed to our goal: commercial success for Hemolink(TM) " said John W. Kennedy, President and CEO. "We are very pleased that Hemolink(TM)'s safety profile has been confirmed with this study. Over the next few weeks we will complete further analysis of the data with our investigators to better understand the clinical significance of the efficacy parameters."
Hemolink(TM) is a highly purified human-derived hemoglobin replacement product manufactured through a series of proprietary processes. Potential benefits of Hemolink(TM) include greater assurance of safety from viral and bacterial contamination; universal compatibility with all blood types; efficient oxygen delivery to tissues; a reduced risk of allergic or immune reaction that may occur with donor blood transfusion; and an extended shelf life of more than one year compared with 42 days for donor blood. The Company anticipates that these potential benefits will provide the medical community and the public with new ways of avoiding or reducing the use of donor blood and complications related to untreated acute hemoglobin deficiency. Hemosol has now completed eight clinical trials of Hemolink(TM), one in healthy volunteers, three in orthopedic surgery, one in anemia and three in cardiovascular surgery.
Hemosol is an integrated biopharmaceutical company developing a multi-product pipeline for global markets based on proprietary technologies for use initially in the treatment of hemoglobin deficiencies.
Hemosol media releases are available on the company's Internet web site (www.hemosol.com) and Canada NewsWire (www.newswire.ca).
This document may contain forward-looking statements that are inherently subject to risks and uncertainties. The words "estimate", "project", "intend", "expect", "believe" and similar expressions are intended to identify forward-looking statements. The Company's actual results could differ materially from those currently anticipated due to a number of factors, including, but not limited to, technical or manufacturing or distribution issues, the competitive environment for the Company's products, the degree of market penetration of the Company's products, and other factors set forth in reports and other documents filed by the Company with Canadian securities regulatory authorities from time to time.
For further information
John W. Kennedy, President & CEO, Lee Hartwell, Vice President, Corporate Development & CFO, Tel: (416) 798-0700, Fax: (416) 798-0152
Jason Hogan, Investor Relations, Tel: (416) 815-0700, Ext 222, Fax: (416) 815-0080, E-Mail: firstname.lastname@example.org
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