Firm Works on ‘Disease-Free’ Blood Substitute : Oxygenetics Plans to Build Factory Before It Begins Clinical Testing of Product
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.
European Introduction
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.
Smith, however, said researchers at Baxter Healthcare have determined that hemoglobin is inherently toxic but can be treated to neutralize the toxic agents. Their tests, however, have only been on animals.
Fratantoni said he also is concerned that cow hemoglobin could be rejected by humans and that, because it usually retains some contamination from surrounding membranes, there is no certainty that a given batch would not transmit disease.
Fratantoni said he believes that the blood and blood donor screening currently being enforced at blood banks makes the risk of contracting AIDS from fresh blood transfusions “very minute.”
Uniform Quality Cited
Lofink, however, contends that his researchers have “been able to separate it (hemoglobin from red cells) where we feel it is chemically and biologically pure,” with no side problems of disease or toxicity.
He said that while other scientific researchers have been able to separate hemoglobin from blood cells in laboratories, he and his associates are the first to have developed a process that can produce hemoglobin of uniform quality on a commercial scale.
Lofink said he believes that cows are an especially good source of hemoglobin because they are already being raised for meat and other commercial uses.
He noted that one of the criticisms of manufacturing hemoglobin from red blood cells is that there may not be a large enough supply of raw blood for the process.
And Smith, whose firm is working under an Army contract to devise a process for mass producing human hemoglobin, agreed that even if human hemoglobin can be commercially manufactured, there may not be a large enough supply of fresh blood to make it worthwhile.
Lofink said he figures that cow blood can fill the demand.
The hemoglobin produced from cow blood, he said, will be no more expensive than fresh human blood because the manufacturer can depend on a large and consistent quantity of bovine blood produced by “donor herds” of cattle that are specially nourished and screened for any sign of illness.
Lofink said Oxygenetics currently purchases cow blood from a biological resource firm in Fresno.
But the company plans eventually to have its own herds, located near manufacturing plants scattered throughout the United States. Besides the plant in Irvine, he said, the company expects to build a factory in Denver and two others in the Northeast and Southwest.
In the race to be first into the market with a hemoglobin product, Oxygenetics lags behind at least one competitor in obtaining FDA approval for human tests.
“If somebody is going to do it, it is Northfield,” said Richard DeWoskin, chairman of Northfield Laboratories, a corporation based in a Chicago suburb that plans to break ground soon on a plant to produce 10,000 liters of hemoglobin a year by the end of 1988.
DeWoskin said Northfield Laboratories, which received FDA approval to begin testing its own hemoglobin solution in humans last July, is “two to four years ahead of everybody else” in developing a marketable product. Northfield’s hemoglobin is made from human red blood cells.
DeWoskin criticized Oxygenetics for putting “the cart before the horse” by building a large volume manufacturing plant before doing any tests of its hemoglobin solution on animals. Usually, he said, the laboratory work is done first.
But Lofink retorted that Oxygenetics wants to test the hemoglobin that its plant will actually produce, rather than something made in a laboratory. He said he is confident that the hemoglobin that is generated by the plant will meet FDA standards.
“We expect the FDA to move relatively fast (on approving the hemoglobin for marketing in the Unites States),” he said. “I’m banking my whole future on it.”
