Hemosol's Blood Substitute Begins Ph II

Canadian biopharmaceutical company Hemosol has received clearance fromCanada's Health Protection Branch to begin Phase II clinical trials with its red blood cell substitute product, Hemolink. This "is the first hemoglobin-based oxygen carrier to be approved for Phase II" in this country, said Alun Davies, president and chief executive of the company.

At the start of the trial, safety and efficacy of the product will be assessed in patients undergoing surgery such as hip replacement, although other patient groups will also be studied further down the road. No significant cardiovascular, pulmonary or renal side effects were noted in earlier trials, and the dose-related gastrointestinal symptoms experienced were easily managed, reports the company.

Hemolink has also shown that it is capable of stimulating red blood cell production and that it provides a source of readily-available iron. As a result, the company is also planning a separate clinical trial in which it will study Hemolink in patients with specific anemias, such as those associated with AIDS and resulting from chemotherapy. An Investigational New Drug application for a Phase II trial in certain anemias will be filed in the near future.