First Patient Trial of Blood Substitute
Product
Is Underway at The Toronto Hospital
(Toronto, May 1, 1997)... The Toronto Hospital announced today the start of Canada's first clinical trial in patients to test the safety and effectiveness of a blood substitute.
Hemolink, an oxygen-carrying red blood cell substitute, will be used during surgery with patients undergoing hip replacements as a way to conserve the patient's own blood. Hemolink, derived from outdated red blood cells (older than 35 days), is produced from the oxygen-carrying protein, hemoglobin, that has been chemically modified. Its primary purpose is the delivery of oxygen to the tissues and organs throughout the body, a critically important procedure during surgery or trauma situations. It is produced by Hemosol, a Canadian biopharmaceutical company based in Toronto.
"This trial is a very important step in finding alternatives which might significantly reduce the need for donated blood," says Dr. Rod Davey, Acting Head, Division of Orthopedic Surgery at The Toronto Hospital and principle investigator of the Hemolink trial. "We recognize there will always be a need for blood transfusions, but we hope that Hemolink will be effective in reducing the need for transfusions thereby helping with the efficient use of the blood supply," adds Dr. Davey, who's also Assistant Professor, Department of Surgery, University of Toronto.
"In our earlier safety studies, we have shown that our product is well tolerated in healthy volunteers. We are confident that the benefits of our approach will be demonstrated in the first patient study," says Dr. Tony Magnin, Hemosol's senior vice president.
The trial will introduce into the surgical procedure a simple step that conserves the patient's own red blood cells and clotting factors. Patients enrolled in the trial will donate one unit of red blood cells one to four weeks before surgery through the Hospital's Autologous Blood Donation Program. Just prior to surgery, a unit of whole blood will be collected from the patient and replaced with Hemolink to maintain optimal oxygen delivery. After the surgery, should transfusion be required, the patient's whole blood and packed red cells will be returned.
The trial procedure will not alter either the surgery or the level of care required in any way.
Sixteen patients will be enrolled in the study which will also have a control group, that is, a group of patients that will not receive Hemolink during surgery.
Hip replacement surgery is invasive surgery which usually requires between one and two units of transfused blood. During the procedure, the weight-bearing joint in the hip is replaced with a synthetic ball and socket. The Toronto Hospital performs about 250 hip replacement surgeries a year.
The Toronto Hospital is the largest acute care teaching facility in Canada. It has approximately 1200 beds. The Hospital has gained an international reputation for excellence in patient care, teaching and research in its four priority programs cardiac sciences, neurosciences, transplantation and oncology.
Hemosol is a Canadian biopharmaceutical company whose focus is the development of blood-related proteins for a variety of indications. Current programs include the commercialization of hemoglobin-based oxygen carriers and red cell stimulators, alternative or supplementary sources of hemoglobin for its blood substitute program and new applications of cell therapy involving propagation of lymphocytes from blood.
For more information, contact:
Josey Panetta
Senior Media Relations Officer,
The Toronto Hospital, 416-340-3303
Dr. Tony Magnin
Senior Vice President, Hemosol Inc.
Mr. Alun Davies
President and CEO, Hemosol Inc.416-798-0700