After more than 20 years of developing a potentially life-saving blood substitute, an Evanston-based laboratory learned its product could soon be approved for use.
Northfield Laboratories Inc. announced Dec. 30 that the Food and Drug Administration has given priority review to its blood substitute, PolyHeme. If its Biologics License Application is approved, Northfield can begin marketing the drug by April 30.
An oxygen-carrying blood alternative, PolyHeme could make emergency transfusions possible in situations where blood is not available, including war zones. Although a clinical trial has found PolyHeme to be less safe than human blood, it has a longer shelf life and is compatible with all blood types.
Northfield’s Chairman and CEO, Steven Gould, called the development a “key milestone” for the company.
“We are now one step closer to delivering a potential life-saving therapy to patients who need transfusion in situations when blood is not available,” he said in a press release.
The news could hardly have come at a better time for Northfield. The company currently has only $15 million left, enough money to keep operating through May, the Chicago Tribune reported on Dec. 30.
Northfield filed its application at the end of October. Under a standard FDA review, the agency has 10 to 12 months to reach a decision. However, with priority review, the FDA will decide within six months.
Investors seemed encouraged by Northfield’s Dec. 30 announcement, as shares of the company jumped 130 percent following the news.
Karen Riley, a press officer for the FDA, declined to comment on PolyHeme but said that financial circumstances have no effect on the agency’s decisions. The FDA assigns priority review to products that could mean a “significant improvement” in treatment, she said.
But according to Dr. John Linehan, a professor of biomedical engineering at Northwestern, priority review does not necessarily indicate a product will be approved.
“The FDA has made a commitment to go from 10 months to six months in the review process, but that does not give a hint that at the end of six months, the review will be positive,” he said.
PolyHeme can last more than a year in storage, according to Northfield. Red blood cells only last 42 days, keeping blood in short supply, said Maureen Crowley, account manager for the Chicago-area blood bank LifeSource.
Another limitation of blood is that people can only receive blood compatible with their type. PolyHeme, however, is “universally compatible,” according to Northfield’s Web site.
Still, PolyHeme has achieved mixed results in clinical trials. In a 2006 study, a higher percentage of trauma patients treated with PolyHeme died within 30 days than those patients receiving standard care.
Repeated messages left for Northfield were not returned. Gould has said that PolyHeme should not be used when blood is available.
The military first started researching the blood alternative after the Vietnam War. Northfield later took over the development of PolyHeme, which is its only product.
In addition to PolyHeme, created from human hemoglobin, scientists have developed other experimental blood substitutes, NU biomedical engineering Prof. Phillip Messersmith said. But none have been approved, which may play in Northfield’s favor during its evaluation, he said.
“You may get approval of a material that’s certainly not ideal but can be approved for use because there are no alternatives,” Messersmith said, “the alternative being almost certain death of a patient that has undergone such a massive blood loss.”
