Proposed Trial to Broaden Indication for PolyHeme's Use;
Also Requests Special Protocol Assessment;
To Pursue Fast Track Designation, Rolling BLA
EVANSTON, Ill., Oct. 16 /PRNewswire-FirstCall/ --
Northfield Laboratories Inc. (Nasdaq: NFLD) announced today that it has
submitted a protocol to the United States Food and Drug Administration (FDA)
for the first use of its oxygen-carrying blood substitute, PolyHeme(TM), in
civilian trauma to treat severely injured patients before they reach a
hospital. Under the proposal, treatment with PolyHeme will begin at the scene
of the injury and continue during transport to the hospital by either ground
or air ambulance.
"This is an exciting step for Northfield, and a significant milestone in
the development of blood substitutes," commented Steven A. Gould, M.D.,
Chairman and Chief Executive Officer. "From the outset we believed that
PolyHeme's most important clinical benefit would be to improve trauma care
beginning at the scene of the injury, in both the military and civilian
settings. A necessary first step was to assess the clinical benefit of
PolyHeme in trauma care in the hospital setting. We have accomplished that
task. Now, with this submission, along with the treatment Investigational New
Drug application (IND) we are developing with the U.S. Army, we have the
exciting prospect of pursing both civilian and military applications
simultaneously."
First Prehospital Civilian Trial for Blood Substitutes
According to Dr. Gould, the protocol represents the culmination of many
months of discussion with the FDA to design the first human trial to assess
the role of a blood substitute as the initial resuscitative fluid in the
prehospital setting. The proposed trial is designed as a multicenter,
randomized, controlled, prospective study to evaluate the safety and efficacy
of PolyHeme in reducing mortality in critically injured and bleeding patients
during field rescue and transport to a trauma center where blood is available.
Due to the difficulty in obtaining consent in the planned study setting, the
submission includes a request for a waiver of informed consent and therefore,
according to FDA regulations, must be submitted as a separate IND. While the
Agency has 30 days to review and comment upon a newly submitted IND, because
of the complex ethical and legal issues in addition to the scientific aspects
of the proposed trial, Northfield anticipates that the FDA may require
additional time for a full evaluation.
Special Protocol Assessment
Northfield also announced that it has submitted a request for special
protocol assessment for the proposed trial. Special protocol assessment
represents acknowledgement and confirmation of a mutual agreement between the
sponsoring company and the FDA that successful completion of the proposed
trial will form the basis for product approval. If agreement is reached, the
FDA reduces the agreement to writing and makes it part of the administrative
record.
Fast Track Designation, Rolling BLA
Northfield also intends to request that PolyHeme be designated as a fast
track product. It may then be possible for certain portions of the Company's
Biologics License Application (BLA) to be accepted for review prior to
completion of the proposed clinical trial, a so-called "rolling BLA."
"Our dialogue with the FDA has been productive and instructive. We are
grateful for the support we have received in developing these plans. However,
although we have discussed each aspect of this approach in detail, this
submission represents the first complete description of the full proposal to
the FDA. Details of the trial size, planned time for completion and cost are
pending a final statistical review by the FDA. We look forward to receiving
the Agency's feedback," Dr. Gould stated.
Dr. Gould characterized Northfield's submission as the initial step in a
potential comprehensive package that would include the first prehospital
civilian trial for a blood substitute, special protocol assessment, fast track
designation, rolling BLA, and a treatment IND for the battlefield use of
PolyHeme. "I believe this multifaceted approach gives us the greatest
opportunity to broaden the proposed indication for PolyHeme, to have a BLA
accepted for review, and to lead to PolyHeme becoming the first approved blood
substitute for use in trauma care," he concluded.
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.
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Related links:
http://www.northfieldlabs.com
CONTACT:
Steven A. Gould, M.D., Chief Executive
Officer, or Investors, Sophia Twaddell, +1-847-864-3500, both of
Northfield Laboratories Inc., or Media, Cindy Martin of FRB Weber
Shandwick, +1-312-640-6741, for Northfield Laboratories Inc.
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