By Randall Osborne
West Coast Editor
Biopure Corp.¿s stock got a shot in the arm after the company disclosed news that the Phase III trial of its oxygen-carrying blood treatment Hemopure met primary safety and efficacy endpoints.
The company¿s shares (NASDAQ:BPUR) rose more than 23 percent Monday, or $4.65, closing at $24.55.
¿We¿ll file [a biologic license application] in the U.S. this year, and in Europe the first half of next year,¿ said Carl Rausch, chairman CEO of Cambridge, Mass.-based Biopure.
¿Everybody asks us what we¿re doing for the FDA, and we¿ve had several discussions with authorities [in Europe], and they¿re anxious to have us file,¿ because of the need for blood products, Rausch said.
In the trial, testing 693 patients, Hemopure was compared to donated blood transfusion in patients undergoing elective orthopedic surgery, and results showed the Hemopure group avoided any blood transfusions during the six-week period, and the risk to them was no worse than those who did.
Made of hemoglobin from bovine red blood cells, Hemopure is purified and formulated in a balanced salt solution. The stabilized, non-cellular hemoglobin molecules are infused to circulate in plasma, and are able to get through constricted or partially blocked vessels where red blood cells cannot so easily move.
The Hemopure molecule is ¿a smaller size, but it also has a different oxygen off-loading characteristic, and it¿s lower in viscosity, so it will work at a lower pressure,¿ Rausch said.
Biopure plans to submit the BLA for perioperative use of Hemopure in patients undergoing elective surgery, based on data from this trial and 19 other studies. South Africa¿s Medicines Control Council approved Hemopure in the spring as a treatment for anemia. (See BioWorld Today, April 11, 2001.)
In the latest trial, the main safety endpoint was that Hemopure patients¿ outcomes were no worse than those for patients treated with allogeneic red blood cells. In agreement with the FDA on statistical methods, Biopure studied the results with regard to adverse experiences patient by patient, rather than in groups, and Hemopure met the endpoint.
¿What you have is a situation where we did a direct comparison,¿ Rausch told BioWorld Today. ¿When a person was called to get blood, they would get our product instead of blood.¿
The efficacy endpoint was elimination of allogeneic red blood cell transfusions. Results showed 96.3 percent of Hemopure patients avoided transfusions the day of surgery, 67 percent at one week after, and about 60 percent at 42 days.
Hemopure has ¿various applications¿ beyond anemia, Rausch said, and cancer treatment is one example.
¿If you can oxygenate tumors, you make them more sensitive to radiation,¿ he said. Trauma and ischemic events such as stroke are other areas where Hemopure might find use.
Biopure intends to submit its BLA electronically ¿ more than 350,000 pages worth, Rausch said.
¿We¿re an integrated manufacturer, so we have to put that section in, too,¿ he said. ¿There¿s been a lot invested in this over the years.¿