New Study Demonstrates Use of Northfield’s PolyHeme® Mitigates Tumor Progression in Pancreatic Cancer Model
05 Março 2009 - 10:00AM
Business Wire
Northfield Laboratories Inc. (Nasdaq: NFLD) announced today 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.
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