Hemosol Inc has received clearance from the U.S. Food and Drug Administration (FDA) to begin a Phase II clinical trial (HLK 210) to assess the efficacy and safety of Hemolink (hemoglobin raffimer), in patients undergoing Orthopedic Surgery.

Based on recent discussions with the FDA, Hemosol expects that HLK 210 and HLK 213, an ongoing study in primary coronary artery bypass grafting (CABG) surgery, will form the basis for the initiation of its Phase III program, pivotal for approval to market Hemolink in the US. The completion of an additional CABG trial, HLK 214 will not be necessary in order to proceed to Phase III.

"Based on this recent guidance from the FDA, we now have a significant amount of clarity regarding the direction of our program in the US. This allows us to proceed toward our objective of starting our Phase III program in 2003," said John W. Kennedy, President and Chief Executive Officer of Hemosol. "We have begun site initiation for HLK 210 and are conducting this trial on a high priority basis."

The HLK 210 trial will be a randomised, single-blind, controlled 80- patient clinical trial to assess the efficacy and safety of Hemolink in patients undergoing high blood loss orthopedic surgical procedures. The primary objective of the study is to determine the efficacy of Hemolink in avoiding the transfusion of banked blood within 28 days of a patient's surgery and will have a maximum dose of 300 grams (3000mL) of Hemolink.

As previously reported, enrolment in the ongoing HLK 213 study continues and the third and final interim safety review of the study by the Data Safety Monitoring Board is planned before the end of 2002 with patient enrolment to be completed early in 2003.