But it could be years before the product is approved for other than experimental use. HemoBioTech is in the process of obtaining permission from the Food and Drug Administration (FDA) to conduct clinical trials in the U.S. The company hopes that early next year it will initiate clinical trials on product safety, which will pave the way for human efficacy testing that could be completed by 2011. Clinical trials are set to begin in India early next year. If all goes according to plan, HemoTech is expected to be a cheaper alternative to treating patients with donated red blood cells.
While HemoBioTech is not alone in its quest to create a blood substitute, others have run into difficulty during clinical testing. Northfield Laboratories, Inc., in Evanston, Ill., has been conducting clinical trials for its oxygen-carrying red blood cell substitute, PolyHeme, but in May said the product failed to meet the primary goals of mortality and safety in an important phase III study. Biopure Corporation in Cambridge, Mass., is working on FDA approval for its "oxygen therapeutics," which are intravenously administered to deliver oxygen to the body's tissues, after the agency in July 2005 put the company's clinical trials on hold, citing safety issues. Last month, Biopure launched a revamped clinical development program, emphasizing testing in Europe, with three phase II clinical trials planned for 2008 to study the impact of its product on heart attack patients, chemotherapy patients with anemia and the terminally ill.
Another blood substitute provider, Synthetic Blood International, Inc., in Costa Mesa, Calif., has thus far successfully navigated the clinical trial waters with Oxycyte, an oxygen-carrying intravenous emulsion that the company says can carry up to four times more oxygen than hemoglobin. In May, Synthetic Blood announced its phase II study in patients with traumatic brain injury indicated Oxycyte helped increase blood oxygen levels.
Although there is no guarantee that any of these blood substitutes will make the grade, each holds the promise of bringing relief to the health care organizations and their patients that rely on rapidly declining supplies of donated blood.