Biopure Corp. reported hemodynamic comparison results at the International Anesthesia Research Society’s 76th Clinical and Scientific Congress in San Diego, from its Hemopure vs. red blood cells Phase III trial, driving up its stock price by more than 40 percent.
The efficacy results from the intent-to-treat patient population showed an avoidance of red blood cell transfusions in 59.4 percent of the Hemopure-treated patients at 42 days post-surgery, 70.3 percent at one week following surgery and 96.3 percent on the day of surgery itself.
Cambridge, Mass.-based Biopure’s stock (NASDAQ:BPUR) rose $3.13 Wednesday, or 39 percent, to close at $11.15.
The trial was a randomized, red blood cell-controlled, single-blind and parallel-group study. It evaluated Hemopure as an alternative to allogeneic red blood cell transfusion in patients undergoing elective orthopedic surgery. A total of 693 patients were enrolled, of which 350 received Hemopure, 338 were given allogeneic red blood cells and five were randomized but not treated. In August, Biopure released data saying the trial had reached primary safety and efficacy endpoints. (See BioWorld Today, Aug. 28, 2001.)
One unit of Hemopure is made of 30 grams of ultrapurified, chemically cross-linked bovine hemoglobin in 250 ml of a balanced salt solution. The company plans to submit an electronic biologics license application with the FDA in mid-2002 for perioperative use of Hemopure to eliminate or reduce red blood cell transfusions in patients undergoing elective surgery, and follow that with an application for marketing in Europe. The product is approved in South Africa for the treatment of adult surgical patients who are acutely anemic and for the purpose of eliminating, reducing or delaying the need for allogeneic red blood cells in adult surgical patients.