Recently Published Trauma Data Leads to Unique Partnership
EVANSTON, Ill., Oct. 4 /PRNewswire-FirstCall/ --
Northfield Laboratories Inc. (Nasdaq: NFLD) announced today that it is
collaborating with the United States Army in developing a treatment IND for
the battlefield use of its oxygen carrying blood substitute, PolyHeme(TM).
Although the Army has had a long-standing interest in the development of a
hemoglobin-based blood substitute, the war on terrorism has led to a greater
sense of urgency about having such a product available for use in battlefield
situations. "The observations in our trauma trial, published in the October
issue of the Journal of the American College of Surgeons, document remarkable
survival rates in patients with massive blood loss and provided the impetus
for this unique collaboration with the Army," commented Steven A. Gould, M.D.,
Chairman and Chief Executive Officer of Northfield.
The publication provides the details regarding the 171 patients who
received rapid infusions of 1 to 20 units of PolyHeme in lieu of red cells as
the initial oxygen-carrying replacement in trauma and urgent surgery. The
study compared the outcome in patients receiving PolyHeme to historical data
on bleeding patients with comparable blood loss who refused blood due to
religious objections. The survival rate in the patients receiving PolyHeme at
the lowest observed hemoglobin levels who had essentially no remaining red
cells in their circulation was 75%. The historical data report no patient
survival at these grave levels. These results document a compelling clinical
benefit, and confirm PolyHeme's life-sustaining capacity in massive blood loss
situations when blood may be unavailable.
"This is a gratifying situation," added Dr. Gould. "We have been in
conversations with the U. S. Army for many years, but the dialogue has
accelerated rather dramatically with the situation in Afghanistan. Our study
design provided a unique opportunity to assess the ability of PolyHeme to
treat urgently bleeding patients in the virtual absence of any circulating red
cells. It represents the most stringent set of experimental conditions but
also reflects the manner in which PolyHeme is likely to be used. Based on the
study and the important observed benefits of our product, we believe PolyHeme
resolves any concerns about the unavailability of blood in the civilian or
military setting, and should therefore be particularly useful in the treatment
of urgent blood loss. We are delighted to reach this stage of joint
development with the U.S. Army."
A treatment IND is typically submitted for experimental drugs showing
promise in clinical testing for serious or immediately life-threatening
conditions while the final clinical work is conducted and the FDA review takes
place. The proposed protocol for the treatment IND would involve the use of
PolyHeme in patients in shock in remote battlefield settings, where red blood
cells are not available. In such difficult circumstances, PolyHeme has the
potential to simplify and facilitate the early treatment of such urgent blood
loss by permitting immediate, rapid, and simultaneous replacement of the lost
volume and hemoglobin that occurs with hemorrhage. The unique benefit of
PolyHeme is its ability to maintain hemoglobin levels in bleeding patients in
the absence of red cell transfusions, and avoid the onset of life-threatening
anemia and subsequent mortality until critical bleeding can be surgically
controlled and red cell transfusions are available. Northfield is the only
company whose clinical trials have assessed survival.
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. These risks include, among others: 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 filings 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:
Steven A. Gould, M.D., Chief Executive
Officer, or Investors, Sophia Twaddell, of Northfield
Laboratories, +1-847-864-3500, or Media, Cindy Martin of FRB
Weber Shandwick, +1-312-640-6741
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