New Study Demonstrates Use Of Northfield's PolyHeme(R) Mitigates Tumor Progression In Pancreatic Cancer Model

Main Category: Pancreatic Cancer
Article Date: 08 Mar 2009 - 1:00 PDT

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Northfield Laboratories Inc. (Nasdaq: NFLD) announced that researchers from the University of Colorado at Denver / Denver Health Medical Center, Bonfils Blood Center in Denver, and University of Texas Southwestern Medical Center at Dallas have demonstrated that the use of Northfield's human polymerized hemoglobin (PolyHeme®) significantly reduces metastases and primary tumor growth in a mouse model of pancreatic cancer. The authors suggest that the use of PolyHeme in lieu of red blood cells may prolong survival in patients with pancreatic cancer who require transfusions. The research is being presented by Carlton C. Barnett, M.D., Director of Surgical Oncology at Denver Health Medical Center, at the Society of Surgical Oncology 62nd Annual Cancer Symposium, which begins today and continues through Saturday in Phoenix, AZ.

As many as 80% of patients undergoing operation for pancreatic cancer receive perioperative red blood cell transfusion. The literature describes an association with decreased survival in these transfusion recipients. Ernest E. "Gene" Moore, M.D., and colleagues previously demonstrated that the plasma fraction of stored red blood cells contains biologically active factors that cause immune dysfunction. Furthermore, they demonstrated that PolyHeme is devoid of these factors and attenuates the observed immune dysfunction. Dr. Barnett and his colleagues have determined that elevations of some of these factors have been associated with primary tumor progression and decreased survival in a mouse model of pancreatic cancer. Based upon these findings, they hypothesized that infusion of PolyHeme in lieu of red blood cells might mitigate the adverse affects of blood transfusion on pancreatic cancer progression.

This study compared the outcome of treatment with PolyHeme or plasma from stored red blood cells in a mouse model of pancreatic cancer. PolyHeme did not demonstrate the elevated levels of biologically active factors observed in the plasma from stored red blood cells. Furthermore, metastases and primary tumor growth were significantly reduced in animals receiving PolyHeme compared to animals receiving plasma from stored red blood cells. These results warrant further study of the potential role for administration of PolyHeme in lieu of red cells to mitigate transfusion-mediated pancreatic tumor progression.

About Northfield Laboratories

Northfield Laboratories is a leader in developing a hemoglobin-based oxygen-carrying red blood cell substitute. The initial indication we are seeking for our investigational product PolyHeme is the treatment of life-threatening red blood cell loss when an oxygen-carrying fluid is required and red blood cells are not available. PolyHeme is a solution of chemically modified human hemoglobin that requires no cross-matching and is therefore compatible with all blood types. It has an extended shelf life in excess of 12 months. For further information, visit http://www.northfieldlabs.com.

Forward Looking Statement

This press release may contain forward-looking statements concerning, among other things, Northfield's future business plans and strategies and clinical and regulatory developments affecting our PolyHeme red blood cell substitute product. These forward-looking statements are identified by the use of such terms as "intends," "expects," "plans," "estimates," "anticipates," "should," "believes" and similar terms. These forward-looking statements involve inherent risks and uncertainties. Our actual results may therefore differ materially from those predicted by the forward-looking statements because of various factors and possible events, including the possibility that FDA may not meet the required time periods for the review of our BLA under applicable laws, regulations and guidances, our potential inability to obtain FDA approval to market PolyHeme commercially based on our BLA, our potential inability to regain compliance with applicable Nasdaq listing standards, our need to obtain additional capital to finance our ongoing business operations and the construction of an expanded commercial-scale manufacturing facility, our potential inability to obtain adequate supplies of raw materials and to manufacture PolyHeme in commercial quantities, our potential inability to market PolyHeme successfully, the possibility that competitors will develop products that will render PolyHeme obsolete or non-competitive, our potential inability to protect our intellectual property rights, the outcome of a purported class action lawsuit as described in our most recently filed quarterly report on Form 10-Q, the possibility that we may be subject to product liability claims and other legal actions, our dependency on a limited number of key personnel, the uncertainty of third party reimbursement for our product and other risks and uncertainties described from time to time in our periodic reports filed with the Securities and Exchange Commission, including our most recently filed annual report on Form 10-K and quarterly report on Form 10-Q. These forward-looking statements speak only as of the date of this press release. We do not undertake any obligation to update or publicly release any revisions to forward-looking statements to reflect events, circumstances or changes in expectations after the time such statement is made. All subsequent written and oral forward-looking statements attributable to Northfield or any person acting on our behalf are qualified by this cautionary statement.

Northfield Laboratories Inc.