Operating in the face of skepticism from competitors and medical researchers, an Orange County company says it is developing a "disease-free" hemoglobin that can eliminate the risk of contracting AIDS and hepatitis from blood transfusions.
The hemoglobin, a product extracted from red blood cells, will be produced from cows' blood by Oxygenetics, which is so confident of its abilities that it plans to build a large manufacturing facility in Irvine before it begins clinical testing of the product.
George Lofink, president, chairman and chief executive officer of the year-old company temporarily based in Newport Beach, said bovine hemoglobin can provide a substitute for human blood, and, unlike human blood, it is not susceptible to contamination by viruses causing acquired immune deficiency syndrome and certain types of hepatitis.
Oxygenetics is joining a host of private firms and university researchers that have stepped up research on blood substitutes in the wake of public concern about the transmission of AIDS through blood transfusions.
While Oxygenetics initially was funded largely through a private stock sale, Robert Winslow, director of the blood research division of the Letterman Army Institute of Research in San Francisco, said some private hemoglobin research firms are being financed by venture capital firms.
Gambling on Success
In either event, investors are gambling that whoever succeeds first in developing a blood substitute will reap a commercial bonanza.
Lofink, an industrial pharmacist and former general manager of the Irvine blood-processing operation of Ciba Corning Diagnostics, said Oxygenetics has applied for a patent on its process.
The company raised $750,000 in a private stock sale last summer and recently received Securities and Exchange Commission approval to make a public offering of 1.3 million common shares at $5 a share. Proceeds from the offering, Lofink said, would be used to equip the 15,000-square-foot manufacturing facility the company has agreed to lease in the Irvine Co.'s Spectrum development.
Despite Lofink's enthusiasm about Oxygenetics' chances of being the first to crack the potentially lucrative blood substitute market, researchers so far have had more problems than successes in using hemoglobin, largely because of toxic reactions.
And other problems, including potential human incompatibility with hemoglobin from animals, also must be overcome.
Lofink said his company plans to complete construction next year of a hemoglobin manufacturing plant that can manufacture up to 2 million pints a year and will then begin testing the hemoglobin on animals.
After conducting clinical tests on humans--a process expected to begin in 1989--Oxygenetics hopes to receive approval from the Food and Drug Administration to start marketing its product to hospitals throughout the United States by 1990, Lofink said.
But he said he expects to start selling the hemoglobin in Europe as early as 1989, largely because many European nations have less restrictive marketing regulations than does the United States.
Winslow, at the U.S. Army's Letterman research institute, said his work on hemoglobin is part of the Army's 20-year effort to develop a blood substitute. The Army, he said, is interested in the possibility of freeze-drying hemoglobin. The resulting lightweight powder would have a long shelf life and could be carried into battlefields and reconstituted with water.
Because hemoglobin is compatible with any blood type, Winslow said, it would be useful to paramedics--either freeze-dried or as a liquid--because they could readily administer it to anyone injured in an accident.
And because hemoglobin carries oxygen, Winslow said, it could also serve as a storage and transportation medium for human organs used in transplants.
Hemoglobin, however, can carry oxygen in the human bloodstream for only a few hours and thus, while potentially valuable for use in emergency situations, will never be a replacement for whole red blood cells, said Dale Smith, group president in charge of blood products for Baxter Healthcare Corp., the big Deerfield, Ill.-based health care products and services provider.
Damage to Organs
In the past, the major drawback researchers have encountered in testing hemoglobin is that it often causes liver and kidney damage in both animals and humans.
But Baxter and Northfield Laboratories both say their recent tests with human hemoglobin have not resulted in any toxic reactions.
Joseph Fratantoni, chief of the U.S. Food and Drug Administration's laboratory of cellular components and a specialist in the field of blood chemistry, said it still is unclear what causes the toxicity of hemoglobin compounds that have been used in animal and human experiments. Researchers don't know whether the hemoglobin itself is toxic or if the toxicity comes from the process of separating the hemoglobin from red blood cells and chemically preserving it, he said.