EVANSTON, Ill., Nov. 11 /PRNewswire-FirstCall/ --
Northfield Laboratories Inc. (Nasdaq: NFLD) announced today that it had
received a response from the Food and Drug Administration (FDA) with questions
and comments regarding its proposed trial to assess the role of its oxygen-
carrying blood substitute, PolyHeme(TM), in treating severely injured patients
before they reach a hospital. The FDA's response continued to encourage the
concept of a civilian trauma study in the urban prehospital setting, including
the proposed primary endpoint of increased survival.
The response included questions and comments related to many of the
administrative aspects of conducting such a trial in order to be certain that
all requirements of the specific regulation allowing for a waiver of consent
are fully satisfied. In particular, there were comments regarding the role of
both the hospital Institutional Review Board (IRB) and the local community in
authorizing such a study. There were additional comments related to the
collection and monitoring of clinical data to ensure maximum safety of the
enrolled patients. Because of the complex ethical and legal issues associated
with obtaining a waiver of informed consent, Northfield had previously
announced that it anticipated that the FDA would require more than the
traditional 30-day review period to complete its evaluation.
Commenting on the FDA's response, Steven A. Gould, M.D., Chairman and
Chief Executive Officer stated, "We understand the FDA's request for
additional information in view of the novel and ground-breaking aspects of
this proposal, and the need to assure patient safety. We anticipate receiving
further comments in the next several weeks as part of the response to our
request for special protocol assessment. At that time, we will provide all
the requested information as soon as possible, and will look forward to
receiving the Agency's feedback."
About Northfield Laboratories
Northfield Laboratories is a leading developer of an oxygen-carrying blood
substitute. Its product, PolyHeme, is the only blood substitute that has been
rapidly and safely infused in sufficiently massive quantities to be considered
useful in the treatment of large volume blood loss in trauma and surgical
settings. PolyHeme requires no cross matching, making it immediately
available and compatible with all blood types. It has an extended shelf life
of over 12 months and does not transmit disease.
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 possible refusal of the FDA to accept or approve the company's proposed
new INDs relating to civilian and military trauma settings, its request for a
special protocol assessment or its request for fast track designation, 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.
For further information on Northfield Laboratories, visit the website at
http://www.northfieldlabs.com .
SOURCE Northfield Laboratories Inc.
 back to top
Related links:
http://www.northfieldlabs.com
CONTACT:
Steven A. Gould, M.D., Chief Executive
Officer, or Investors, Sophia Twaddell, both of Northfield
Laboratories, +1-847-864-3500, or Media, Cindy Martin of FRB
Weber Shandwick, +1-312-640-6741
|
