Northfield Laboratories Inc. Announces Result of Fourth Interim Analysis of PolyHeme Pivotal Phase III Study
November 15 2005 - 7:00AM
PR Newswire (US)
- Study Continues Without Modification - EVANSTON, Ill., Nov. 15
/PRNewswire-FirstCall/ -- Northfield Laboratories Inc.
(NASDAQ:NFLD) announced today that the Independent Data Monitoring
Committee (IDMC) has recommended that the Company's pivotal Phase
III trial with PolyHeme(R) continue without modification following
the fourth planned interim analysis of the study data. The IDMC
reviewed blinded data on mortality in the first 500 patients
enrolled in the study. This is the first time a hemoglobin-based
oxygen-carrying resuscitative fluid has successfully passed this
patient evaluation milestone in the high-risk trauma population.
"This is a key milestone for Northfield and our development of
PolyHeme," said Steven A. Gould, M.D., Chairman and Chief Executive
Officer. "We are extremely pleased with this fourth recommendation.
Northfield has made sustained progress in the trial this year and
we are looking forward to completing enrollment early next year."
Northfield's pivotal Phase III study is designed to evaluate the
safety and efficacy of PolyHeme(R), the Company's human
hemoglobin-based oxygen- carrying resuscitative fluid, when
administered to patients in hemorrhagic shock following traumatic
injury. It is the first study in the United States in which
treatment with an oxygen-carrying resuscitative fluid begins at the
scene of injury. Patients are currently being enrolled at 24 Level
I trauma centers throughout the United States, with a planned total
enrollment of 720 patients. The primary endpoint is survival at 30
days. The IDMC is a group of experts, not associated with
Northfield, responsible for periodically evaluating the safety data
from the study and making recommendations relating to the
continuation or modification of the study to minimize any
identified risks to patients. The four "interim looks" were defined
in the study protocol and were scheduled to occur after the first
60, 120, 250 and 500 patients were enrolled and followed for a
30-day period. As with each preceding interim analysis, the IDMC
will continue to receive and assess all cumulative safety data on
the patients enrolled for this review, focusing on mortality and
serious adverse events. Northfield receives a recommendation after
each review, but does not have access to the actual data or the
IDMC deliberations. The Company will remain shielded from the data
until the study is complete. About Northfield Laboratories
Northfield Laboratories Inc. is a leader in developing an
oxygen-carrying resuscitative fluid, PolyHeme(R), for the treatment
of urgent, large volume blood loss in trauma and resultant surgical
settings. PolyHeme(R) is a solution of chemically modified human
hemoglobin that requires no cross matching and is therefore
compatible with all blood types. It has a shelf life of over 12
months. Enrollment is currently underway in a pivotal Phase III
study of PolyHeme(R) beginning in the pre-hospital setting. For
further information about Northfield Laboratories, visit
http://www.northfieldlabs.com/ This press release contains
forward-looking statements concerning, among other things,
Northfield's future business plans and strategies and clinical and
regulatory developments affecting our PolyHeme blood 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 our ability to
obtain FDA approval to market PolyHeme commercially, the
availability of capital to finance our clinical trials and ongoing
business operations, our ability to obtain adequate supplies of raw
materials and to manufacture PolyHeme in commercial quantities, our
ability to market PolyHeme successfully, the possibility that
competitors will develop products that will render PolyHeme
obsolete or non-competitive, our ability to protect our
intellectual property rights, 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
Fourth, Final 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 quarterly report on Form 10-Q and
annual report on Form 10-K. 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. FOR FURTHER INFORMATION CONTACT: Sophia
H. Twaddell Vice President, Corporate Communications (847) 864-3500
Sharon L. Weinstein Noonan Russo (212) 845-4271 DATASOURCE:
Northfield Laboratories Inc. CONTACT: Sophia H. Twaddell, Vice
President, Corporate Communications of Northfield Laboratories
Inc., +1-847-864-3500, ; or Sharon L. Weinstein of Noonan Russo for
Northfield Laboratories Inc., +1-212-845-4271, Web site:
http://www.northfieldlabs.com/
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