Presentation at American College of Surgeons Details the Remarkable Benefits
Of PolyHeme in the Treatment of Urgent, Massive Blood Loss
EVANSTON, Ill., Oct. 11 /PRNewswire/ -- Northfield Laboratories Inc.
(Nasdaq: NFLD; NMS), today presented data from trauma trials of its patented
blood substitute, PolyHeme(TM), at the American College of Surgeons annual
meeting in New Orleans. The data confirmed the product's life-sustaining
capacity in massive blood loss situations when blood may be unavailable. In
late August, Northfield became the first in its field to submit a Biologics
License Application to the Food and Drug Administration (FDA) for an oxygen-
carrying blood substitute for human use.
Speaking to a group of the nation's most prominent surgeons, Dr. Steven A.
Gould, president of Northfield, told his audience that the company's objective
for its trauma trial was to assess survival in urgent blood loss situations in
patients with life-threatening red blood cell hemoglobin levels when blood may
not be available. When evaluating the data, the company found overwhelming
evidence that the use of PolyHeme substantially increased survival rates in
these critical circumstances.
Northfield's study compared patients receiving PolyHeme for treatment for
massive blood loss to historical data on bleeding patients with comparable
blood loss who refused blood due to religious objections. The red blood cell
hemoglobin levels were assessed according to the National Institutes of Health
guidelines for transfusion: a hemoglobin level of 12-15 gm/dl is in the normal
range; transfusion is not recommended at a level greater than 10; at a level
below seven, transfusion usually occurs; and a level of three or less is
considered life-threatening. For purposes of this trial, Northfield is most
interested in outcome data from patients at life-threatening hemoglobin levels
of three or below.
"We unequivocally achieved our goal in this trial, reporting survival
rates of 75 percent in patients with substantial blood loss, which is
considerably higher than the historical survival rate of just 20 percent,"
Gould said. "Additionally, PolyHeme was able to sustain its 75 percent
survival rate in patients with hemoglobin levels of two, one, and remarkably
even in patients with hemoglobin levels below one -- basically patients with
no circulating red blood cells. The historical data report no patient
survival at these grave levels. Using PolyHeme, we were able to meet our
objective of increasing and maintaining total hemoglobin levels in the safe
range of seven or greater in the absence of red blood cell transfusions.
"Our trial results document a very compelling clinical benefit. In
addition to substantially reduced mortality in the virtual absence of red
cells, PolyHeme is disease-free and can be given to any individual without the
need for compatibility testing, eliminating the concern about transfusion
reactions. The product has a shelf life in excess of 12 months, versus the
42-day maximum shelf life of stored blood."
With the efficacy of the product established in the trial outcome data,
Gould addressed PolyHeme's safety record. He reported no evidence of blood
vessel constriction, or renal, pancreatic, gastrointestinal or cardiac
dysfunction. He said the company has encountered no serious product-related
adverse events. "The results demonstrate that the use of PolyHeme is safe
during rapid and massive infusion. This is an essential requirement, since
that is how a blood substitute is likely to be used in the setting of urgent
blood loss. As an oxygen-carrying alternative, we believe that PolyHeme
represents an ideal resuscitative fluid."
PolyHeme's Production, Use and Trial Protocol Unique
Gould noted in his presentation that PolyHeme was very different from
other blood substitute products under development in terms of its technology,
focus and benefits. The production of PolyHeme starts with human red blood
cells -- approximately 1.7 units of starting human red cells make up one unit
of PolyHeme. The active ingredient inside the red blood cell is the four-part
hemoglobin molecule known as the tetramer. It is the hemoglobin protein that
carries oxygen in humans. Northfield makes PolyHeme by opening the red cell
to extract the hemoglobin protein. Unlike the red blood cell, the hemoglobin
itself is universally compatible, and stable during prolonged storage.
However, Gould said, when the hemoglobin in the form of the tetramer is
outside of the red cell, it is unsafe because of its small size. Northfield
resolves this problem of scale by linking many small molecules together to
make larger molecules called polymers, and purifying to remove all
unpolymerzied hemoglobin -- an important and proprietary aspect of the
company's technology.
In addition to a manufacturing process that ensures PolyHeme is
tetramer-free, or free of unlinked tetramers, PolyHeme is unique in that it is
the only blood substitute that has been tested in a trauma setting. In
certain massive blood-loss situations, Northfield has infused patients with up
to 20 units of PolyHeme, twice the normal total blood volume, in as brief a
period as 20 minutes -- an extraordinary achievement. In comparison, in
competitor trials, the PolyHeme equivalent of only six units of their products
are being infused over a period of several days. In Northfield's trauma
trial, 20 percent of PolyHeme recipients have been given 10-20 units of the
product.
Northfield is the only sponsor assessing survival in a clinical trial.
Others are studying blood substitutes simply for the elimination of the use of
donated blood.
Gould concluded his remarks to the American College of Surgeons with a
strong summation of PolyHeme. "We have demonstrated that using PolyHeme for
patients with life-threatening blood loss substantially increased survival
rates, and that patients' total hemoglobin levels were able to be maintained
at safe levels. These data establish that PolyHeme is safe during rapid,
massive infusion. Based on the study and the important benefits of our
product, we believe PolyHeme resolves any concerns about the unavailability of
blood, and should therefore be particularly useful in the early treatment of
urgent blood loss."
About the Company
Northfield Laboratories, founded in 1985, is a leading developer of an
oxygen-carrying blood substitute. The company is headquartered in Evanston,
Illinois, and its stock is traded on the Nasdaq National Market System under
the symbol NFLD.
Statements in this release that are not strictly historical are "forward-
looking" statements that are made pursuant to the safe harbor provisions of
the Private Securities Litigation Reform Act of 1995. Forward-looking
statements involve known and unknown risks, which may cause the company's
actual results in the future to differ materially from expected results.
Northfield cautions that the FDA approval process for PolyHeme continues to be
subject to significant risks and uncertainties. The FDA could refuse to
accept Northfield's BLA in its current form. If Northfield's BLA is accepted,
the FDA could deny its approval for the commercial sale of PolyHeme or could
require additional clinical tests as a condition to its approval. If FDA
approval for the commercial sale of PolyHeme is granted, the indication uses
for which PolyHeme may be marketed could be significantly limited by the FDA.
Other risks may include: competition from other blood substitute products; the
company's ability to obtain regulatory approval to market PolyHeme
commercially; the company's and/or its representative's ability to
successfully market and sell PolyHeme; the company's ability to manufacture
PolyHeme in sufficient quantities; the company's ability to obtain an adequate
supply of raw materials; the company's ability to maintain intellectual
property protection for its proprietary product and to defend its existing
intellectual property rights from challenges by third parties; the
availability of capital to finance planned growth; and the extent to which the
hospitals and physicians using PolyHeme are able to obtain third-party
reimbursement, as described in the company's filing with the Securities and
Exchange Commission.
Visit the Northfield website at: http://www.northfieldlabs.com
SOURCE Northfield Laboratories Inc.
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Related links:
http://www.northfieldlabs.com
CONTACT:
Richard DeWoskin, Chief Executive Officer of
Northfield Laboratories, +1-847-864-3500, or General, Leslie
Hunziker, +1-312-640-6760, Analysts, Bill Schmidle,
+1-312-640-6753, Media, Cindy Martin, +1-312-640-6741, all of
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