Hemopure, developed and produced by OPK Biotech, is a hemoglobin-based oxygen carrier based on chemically stabilized bovine hemoglobin. It has been developed for potential use in humans as an oxygen delivering bridge in cases when blood is not available or is not an option. The product, Hemoglobin-glutamer 250 (Bovine) approved for human use and sale in South Africa for several years.
"Oxyglobin", a similar product Hemoglobin-glutamer 200 (Bovine) or HBOC-301 was approved for use to treat canine anemia in 1998.
According to the company, Hemopure is stable for 36 months at room temperature, compatible with all blood types (no requirement for blood typing, testing or cross-matching, it is purified to remove or inactivate potential contaminants, including infectious agents (e.g. viruses, bacteria and TSE agents).
In the last completed human trial of Hemopure in the United States, Hemopure was not found to be inferior to blood. However, safety concerns did arise which led the FDA to impose a ban on further clinical testing of the product on human test subjects in the United States. FDA spokeswoman Karen Riley said in a statement "There have been significant safety concerns raised about this class of products." Conversely, the US Navy criticized the FDA. According to the Navy the FDA's review of Hemopure was flawed: "The reviews had consistent patterns of erroneous, misleading, and anecdotal statements, reporting bias, changing requirements, no 'sense of urgency,' " as well as conflicts of interest.
The FDA and Biopure reached an agreement to conduct a series of animal tests designed to study those safety concerns and determine whether a new round of human testing could safely be initiated. Most, if not all, of these tests have been completed and their findings submitted and studied by the FDA. Outside the United States, human testing of Hemopure is allowed in South Africa and in Europe.
The U.S. Naval Medical Research Center, which had been collaborating with Biopure in the study of Hemopure, was granted $4 million in additional Congressional funding for the United States Navy to continue research and development of Hemopure. This was through the FY 2006 Defense Appropriations Bill signed by President George W. Bush on December 30, 2005.
Human use approval
Hemopure has also been requested and used in compassionate use cases. A recent case was for a 33-year-old Australian woman who was severely injured in a car crash.
Hemopure, as with any oxygen carrying therapeutic, carries a risk of being used improperly as a performance enhancement in sports. According to VeloNews, on July 20, 2007, Tour de France leader Michael Rasmussen was accused by mountain bike racer Whitney Richards of attempted Hemopure smuggling for potential later use in a doping program.
Biopure, the original developers and producers of Hemopure and Oxyglobin, filed for bankruptcy protection under Chapter 11, Title 11, United States Code in 2009 Its assets were subsequently purchased by OPK Biotech, a privately held firm headquartered in Cambridge, Massachusetts.
- Hemopure attributes OPK Biotek info page
- Wallack, Todd (April 4, 2009). "Navy rips FDA for blocking clinical trial". The Boston Globe.
- Biopure Begins Selling Hemopure in South Africa PR Newswire (Biopure) January 05, 2006
- An Australian woman's life has been saved using a radical synthetic blood substitute made from cow plasma
- Charles Pelkey (July 20, 2007). "Ex-cyclist levels doping charges at Rasmussen". VeloNews.com.
- Biopure files for relief PR Newswire, July 16, 2009.
- Biopure Corp. Case Study. Harvard Business School