Northfield Labs Receives Clearance to Test Blood Substitute at
10-Unit Level
Company Cites Progress Toward Phase III Clearance
EVANSTON, Ill., Nov. 20 /PRNewswire/ -- Northfield Laboratories Inc , has received clearance from the Food and Drug Administration to conduct clinical trials of its blood substitute, PolyHeme(R), at the ten-unit level, which is equivalent to replacing the total blood volume of an adult human being.
The expanded study will be conducted under the Phase II protocols that Northfield Labs has followed during the past year. Previously, the company has infused patients with up to six units of PolyHeme, equivalent to six units of blood. Approximately 80 percent of all blood transfusions are at the six unit level or below, the company
noted. In announcing the expanded study, Richard DeWoskin, chairman and chief executive officer, said, "The clinical trials at a higher dosage will allow the company to explore broader indications."
At the same time, the company indicated progress in its application for Phase III trials of the blood substitute. DeWoskin said Northfield Labs is seeking approval to conduct multi-site trials of PolyHeme under a Phase III protocol. The company must determine which of the Food and Drug Administration's recent recommended courses of action will be pursued.
"The FDA has indicated alternatives that are acceptable to that agency," DeWoskin said. "Now it is up to us to choose the best alternatives to pursue. While we cannot predict precisely when FDA clearance will be received for the Phase III trials, we are encouraged by the FDA's responses and will move expeditiously to obtain
clearance and begin the final testing as quickly as possible."
"We are excited to see our efforts coming closer to our goal: to provide an oxygen-carrying blood substitute that requires no cross-matching, has a long shelf life and does not transmit disease," he added.
According to Steven Gould, Northfield's president, members of the medical community appear to be highly receptive to PolyHeme as a potential transfusion option in trauma cases. Gould presented data on the company's research last week at the Detroit Trauma Symposium.
"Surgeons and trauma physicians from throughout the country indicated a strong desire to have a blood substitute product available in trauma and urgent surgery settings," Gould reported. "From discussions I have
had with physicians when making presentations on our product, PolyHeme, it appears that there would be strong acceptance for the product based on its ease of use and benefits for the resuscitation of trauma patients."
Northfield Laboratories was founded in 1985. The company is a leader in the development of blood substitutes. Northfield Laboratories is headquartered in Evanston, Illinois, and its stock is traded on the Nasdaq National Market under the symbol NFLD. SOURCE Northfield Laboratories Inc. |
