Hemopure
Encyclopedia
Hemopure, developed by Biopure
(BPUR), is an 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. Hemopure carries a risk of being used improperly as a performance enhancement in sports, may cause reactions, or may carry infection. The product, Hemoglobin-glutamer 250 (Bovine) was approved for human use and sale in South Africa for several years.
A similar product Hemoglobin-glutamer 200 (Bovine) or HBOC-301 was approved for use in animals.
, 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
).
of Hemopure in the United States, Hemopure was not found to be inferior to blood. However, safety concerns did arise which caused the FDA
to impose a ban on further clinical testing of the product on human test subjects in the United States, citing some studies which linked hemopure to toxic effects including kidney and heart damage. FDA spokeswoman Karen Riley said in a statement "There have been significant safety concerns raised about this class of products." The US Navy criticized the FDA's ban. 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 is collaborating with Biopure in the study of Hemopure, was recently granted $4 million in additional Congressional funding for the U.S. Navy to continue research and development of Hemopure. This was through the FY 2006 Defense Appropriations Bill signed by President Bush
on December 30, 2005. While the FDA has suggested that Hemopure be reformulated to improve its safety profile, discussions are reportedly ongoing between the FDA, Biopure, and Naval and academic researchers over ways of addressing the FDA safety concerns without changing the current product formulation.
April 2001, a first and only for this product class. But due to local politics and distributor conflicts, BPUR has only managed to sell a total of $8,000 worth of Hemopure in South Africa in the intervening five years through July 31, 2006, according to corporate documents.
leader Michael Rasmussen
was accused by mountain bike racer Whitney Richards of attempted Hemopure smuggling for potential later use in a doping program.
The company was the subject of a Harvard Business School
marketing strategy case study.
Biopure
Biopure Corporation was a biopharmaceutical company that specialized in oxygen therapeutics for both human and veterinary use. The company developed, manufactured, and marketed blood substitutes which are designed to imitate the oxygen-carrying function of actual blood without the complications...
(BPUR), is an hemoglobin-based oxygen carrier based on chemically stabilized bovine hemoglobin
Hemoglobin
Hemoglobin is the iron-containing oxygen-transport metalloprotein in the red blood cells of all vertebrates, with the exception of the fish family Channichthyidae, as well as the tissues of some invertebrates...
. 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. Hemopure carries a risk of being used improperly as a performance enhancement in sports, may cause reactions, or may carry infection. The product, Hemoglobin-glutamer 250 (Bovine) was approved for human use and sale in South Africa for several years.
A similar product Hemoglobin-glutamer 200 (Bovine) or HBOC-301 was approved for use in animals.
Attributes
According to the company, Hemopure is stable for 36 months at room temperatureRoom temperature
-Comfort levels:The American Society of Heating, Refrigerating and Air-Conditioning Engineers has listings for suggested temperatures and air flow rates in different types of buildings and different environmental circumstances. For example, a single office in a building has an occupancy ratio per...
, compatible with all blood types (no requirement for blood typing, testing or cross-matching
Cross-matching
Cross-matching blood, in transfusion medicine, refers to the complex testing that is performed prior to a blood transfusion, to determine if the donor's blood is compatible with the blood of an intended recipient, or to identify matches for organ transplants. Cross-matching is usually performed...
, it is purified to remove or inactivate potential contaminants, including infectious agents (e.g. viruses, bacteria
Bacteria
Bacteria are a large domain of prokaryotic microorganisms. Typically a few micrometres in length, bacteria have a wide range of shapes, ranging from spheres to rods and spirals...
and TSE agents
Transmissible spongiform encephalopathy
Transmissible spongiform encephalopathies , also known as prion diseases, are a group of progressive conditions that affect the brain and nervous system of many animals, including humans. According to the most widespread hypothesis they are transmitted by prions, though some other data suggest an...
).
Clinical trials
In the most recently completed human trialClinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
of Hemopure in the United States, Hemopure was not found to be inferior to blood. However, safety concerns did arise which caused the FDA
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
to impose a ban on further clinical testing of the product on human test subjects in the United States, citing some studies which linked hemopure to toxic effects including kidney and heart damage. FDA spokeswoman Karen Riley said in a statement "There have been significant safety concerns raised about this class of products." The US Navy criticized the FDA's ban. The FDA and Biopure reached an agreement to conduct a series of animal tests
Animal testing
Animal testing, also known as animal experimentation, animal research, and in vivo testing, is the use of non-human animals in experiments. Worldwide it is estimated that the number of vertebrate animals—from zebrafish to non-human primates—ranges from the tens of millions to more than 100 million...
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
Europe
Europe is, by convention, one of the world's seven continents. Comprising the westernmost peninsula of Eurasia, Europe is generally 'divided' from Asia to its east by the watershed divides of the Ural and Caucasus Mountains, the Ural River, the Caspian and Black Seas, and the waterways connecting...
.
The U.S. Naval Medical Research Center
National Naval Medical Center
The National Naval Medical Center in Bethesda, Maryland, USA — commonly known as the Bethesda Naval Hospital — was for decades the flagship of the United States Navy's system of medical centers. A federal institution, it conducted medical and dental research as well as providing health care for...
, which is collaborating with Biopure in the study of Hemopure, was recently granted $4 million in additional Congressional funding for the U.S. Navy to continue research and development of Hemopure. This was through the FY 2006 Defense Appropriations Bill signed by President Bush
George W. Bush
George Walker Bush is an American politician who served as the 43rd President of the United States, from 2001 to 2009. Before that, he was the 46th Governor of Texas, having served from 1995 to 2000....
on December 30, 2005. While the FDA has suggested that Hemopure be reformulated to improve its safety profile, discussions are reportedly ongoing between the FDA, Biopure, and Naval and academic researchers over ways of addressing the FDA safety concerns without changing the current product formulation.
Human use approval
Hemopure was approved for human use and commercial sale in South AfricaSouth Africa
The Republic of South Africa is a country in southern Africa. Located at the southern tip of Africa, it is divided into nine provinces, with of coastline on the Atlantic and Indian oceans...
April 2001, a first and only for this product class. But due to local politics and distributor conflicts, BPUR has only managed to sell a total of $8,000 worth of Hemopure in South Africa in the intervening five years through July 31, 2006, according to corporate documents.
Performance enhancement
Any oxygen bridge type product can be abused as a performance enhancer in sports. According to VeloNews, on July 20, 2007, Tour de FranceTour de France
The Tour de France is an annual bicycle race held in France and nearby countries. First staged in 1903, the race covers more than and lasts three weeks. As the best known and most prestigious of cycling's three "Grand Tours", the Tour de France attracts riders and teams from around the world. The...
leader Michael Rasmussen
Michael Rasmussen
Michael Rasmussen is a Danish professional road bicycle racer who rides for the Danish team Christina Watches-Onfone. In the 2007 Tour de France, Rasmussen, while in the yellow jersey, had his contract terminated by his team and was removed from the Tour...
was accused by mountain bike racer Whitney Richards of attempted Hemopure smuggling for potential later use in a doping program.
Corporate history
Biopure, producers of Hemopure and Oxyglobin, filed for Chapter 11 in 2009 and was subsequently purchased by OPK Biotech, a privately-held firm headquartered in Cambridge, MA.The company was the subject of a Harvard Business School
Harvard Business School
Harvard Business School is the graduate business school of Harvard University in Boston, Massachusetts, United States and is widely recognized as one of the top business schools in the world. The school offers the world's largest full-time MBA program, doctoral programs, and many executive...
marketing strategy case study.