Important note: Information in this article was accurate in 2001. The state of the art may have changed since the publication date.
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United Press International - Thursday, 12 April 2001
Ed Susman, UPI Science News
Medical experts say Hemopure will vastly extend the shelf life of blood products as well as decrease risk of transmission of blood-borne diseases such as HIV and hepatitis C. Patients with acute anemia or undergoing surgical procedures will be the first recipients.
Hemopure, called an oxygen therapeutic, is derived from cow's blood. It is designed to deliver oxygen to body tissues so doctors can manage acute anemia patients, said Douglas Sayles, a spokesperson for the 17-year-old company.
"However, Hemopure can also be used in place of blood transfusions," Sayles said. In fact, it is being measured against blood transfusions in advanced clinical trials in the United States, he told United Press International in a telephone interview.
Sayles added the company expects to file with the Food and Drug Administration early next autumn to sell it in the United States as well.
One concern with blood transfusions in South Africa is the prevalence of HIV infection in the country. Some authorities estimate that 25 percent or more of the local blood supply is tainted with HIV, yet units are not routinely tested for the virus that causes AIDS. Hepatitis C and other disease-causing organisms may contaminate an even larger share of the supply.
In addition to being free of such pathogens, Sayles said Hemopure also has a room temperature shelf life of two years or longer. Blood can be stored for about 6 weeks.
"This unique oxygen carrier could profoundly impact public health issues in Africa as the product's purity, compatibility with all blood types and two-year room temperature stability addresses many of the medical and logistical problems surround the treatment of anemia with red blood cells," said Dr. Richard Friedland in a statement. Friedland is chief operating officer of Johannesburg-based Netcare, the largest private doctor/hospital network in South Africa.
Dr. Lewis Levien of Johannesburg, one of the clinical investigators in trials in the South Africa trials, said in his own statement, "When infused, the product acts as an 'oxygen bridge' to help stabilize anemic surgery patients until they manufacture their own red blood cells or compatible red blood cells can be administered."
Anemia is a shortage of red blood cells -- specifically hemoglobin, the oxygen-carrying protein within the cells. The condition can lead to oxygen deficiency that can become life-threatening. Acute anemia, usually caused by blood loss, is the primary indication for red blood cell transfusion.
Researchers began testing Hemopure among U.S. citizens about six years ago, and then testing moved first to Europe and then to Africa, said Biopure's Sayles. More than 20 clinical trials have been conducted in the world, he added, and the company is now calculating results in the United States for the FDA filing.
Biopure is also developing a compassionate use protocol that would make the product available in the United States more quickly for patients who are unable to use blood transfusions for religious or other reasons, he told UPI.
Hemopure is similar to the company's Oxyglobin product, a veterinary drug that has been licensed by the FDA since 1998 for treatment of anemia in dogs. The animal product and the human product differ in their molecular weight, but both are known by the generic name of hemoglobin glutamer.
Although the drug is produced from cattle, Sayles said the risk is less than one in 100 million of contracting the human variant of bovine spongiform encephalopathy, also called BSE or mad cow disease. A 22-step purification procedure removes bacteria, virus and other infectious agents from the raw material that ends up as Hemopure, he explained.
About 2,000 units of Hemopure are going to be sent to South Africa for use in continuing trials. Biopure plans to expand its manufacturing capacity to 100,000 units per year, of which about 30,000 units will go to South Africa.
In the meantime, the company will work with South African health authorities to determine a cost for the product, Sayles said.
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