An independent review panel gave an Evanston biomedical company a historic green light last week to continue clinical trials of a blood substitute that could save thousands of lives across the United States.
Northfield Laboratories, Inc. has been testing a blood substitute known as PolyHeme since January. A periodic review of the trial by experts is required under federal regulations regarding blood substitute testing.
One company official described the panel’s findings as a “huge credential.”
PolyHeme is the first blood substitute administered in a pre-hospital setting and without patients’ consent to have passed its first periodic review. The blood substitute is administered to test subjects in ambulances before they reach the hospital.
“This is a very significant achievement for us,” said Steven A. Gould, M.D., chief executive officer of Northfield. “It represents the validation of all of our work to this point and furthermore it represents the validation of all the efforts we have taken to provide the maximum assurance of patient safety.”
Northfield isn’t waving the victory banner yet, though. Several more interim analyses will take place as more and more patients are enrolled in the trial.
The current trial will take nearly another year to complete, company officials said, and the blood substitute will have to be certified by the Food and Drug Administration before it hits the market.
FDA officials declined to comment on the trial. The FDA usually does not comment on ongoing clinical trials or products that are still under development.
The review panels, officially known as independent data monitoring committees, are appointed by the company conducting the trial, but its members are supposed to be independent and unaffiliated with the company. Northfield’s review board included two clinicians and one biostatistician, Gould said.
“These people are highly regarded in their fields,” he said.
At the very earliest, the substitute will not hit the market for at least a couple of years.
Currently there is no available blood substitute on the market. PolyHeme, which is manufactured using the hemoglobin from discarded blood, has several benefits over donated blood.
Donated blood has a shelf life of only 42 days, company officials said, while PolyHeme would have a shelf life of several months or years.
PolyHeme also can be given to anyone — regardless of blood type. Blood is usually not administered in ambulances because it can take up to an hour for hospitals to determine a patient’s blood type. In contrast, PolyHeme could be given immediately in those emergency situations– and could save thousands of trauma victims.
“Northfield has focused on the use of a product like PolyHeme in the setting off of life-threatening blood loss when blood is not available,” Gould said.
“We have a good blood supply in this country, but nonetheless tens of thousands of patients die from trauma each year — they bleed to death before they have access to blood,” Gould added.
City Reporter Mike Cherney is a Medill sophomore. He can be reached at [email protected].
