2nd phase positive...Northfield Laboratories Inc. Announces Result of Second Interim Analysis of PolyHeme Pivotal Phase III Study Data
/FROM PR NEWSWIRE NEW YORK 800-776-8090/
TO BUSINESS AND MEDICAL EDITORS:
Northfield Laboratories Inc. Announces Result of Second Interim Analysis of
PolyHeme Pivotal Phase III Study Data
- Study Continues Without Modification -
EVANSTON, Ill., Oct. 13 /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 second planned
interim analysis of the study. The IDMC stated, "there are no concerns to
alter the protocol" after a review of blinded data on mortality and serious
adverse events in the first 120 patients enrolled in the study. This is the
first time a blood substitute has successfully passed this patient evaluation
milestone in a Phase III clinical trial in the high-risk trauma population.
The pivotal Phase III study is designed to evaluate the safety and
efficacy of PolyHeme(R), Northfield's human hemoglobin-based oxygen carrier,
when administered to patients in hemorrhagic shock following traumatic injury.
It is the first study in the United States in which treatment with a blood
substitute begins at the scene of injury. Patients are currently being
enrolled at Level I trauma centers throughout the United States, with a target
enrollment of 720 patients. The primary endpoint is survival at 30 days.
"Northfield has reached another significant milestone in this pivotal
trial," said Steven A. Gould, M.D., Chairman and Chief Executive Officer. "We
are encouraged by this second positive recommendation of the IDMC, which once
again confirms the attention to patient safety that characterizes the efforts
of all involved in this complex study. This trial is an important step
towards achieving our goal of bringing PolyHeme(R) to market as the first
blood substitute approved for use in urgent, life-threatening hemorrhage. We
look forward to providing additional updates as the trial progresses."
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. These "interim looks" are
defined in the study protocol and take place after 60, 120, 250 and 500
patients are enrolled and followed for a 30-day period to assess survival.
The IDMC will review all safety data as the study proceeds, focusing on
mortality and serious adverse events. Strict confidentiality of the data is
maintained by the IDMC. Northfield will receive a recommendation from the
IDMC after each review, but does not have access to the actual data or the
deliberations of the IDMC, and will remain shielded from the data until the
study is complete. Patients continue to be enrolled in the study while the
IDMC conducts its reviews of interim data.
About Northfield Laboratories
Northfield Laboratories Inc. is a leader in developing an oxygen-carrying
blood substitute, 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) begiZ kng in the pre-hospital setting.
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 third 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 about Northfield Laboratories, visit
northfieldlabs.com
FOR FURTHER INFORMATION CONTACT:
Steven A. Gould, M.D. Sharon L. Weinstein
Chairman and Chief Executive Officer Euro RSCG Life NRP
(847) 864-3500 (212) 845-4271
sharon.weinstein@eurorscg.com
Sophia H. Twaddell
Vice President, Corporate Communications
(847) 864-3500
stwaddell@northfieldlabs.com
SOURCE Northfield Laboratories Inc.
/CONTACT: Steven A. Gould, M.D., Chairman and Chief Executive Officer,
+1-847-864-3500, or Sophia H. Twaddell, Vice President, CorporateCommunications,
+1-847-864-3500, or stwaddell@northfieldlabs.com, both ofNorthfield Laboratories
Inc.; or Sharon L. Weinstein of Euro RSCG Life NRP,+1-212-845-4271, or
sharon.weinstein@eurorscg.com, for Northfield LaboratoriesInc./
/Web site: northfieldlabs.com /
Oct-13-2004 11:00 GMT
Symbols:
US;NFLD |
