Northfield labs (NASDAQ:NFLD)
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Northfield Laboratories (Nasdaq:NFLD) released the
following statement in response to a Wall Street Journal article on
the company published today: Today's Wall Street Journal article,
"Amid Alarm Bells, Blood Substitute Keeps Pumping" contains several
errors of fact and misinterprets the Acute Normovolemic Hemodilution
(ANH) clinical trial protocol and results. We particularly disagree
with the characterization that Northfield Laboratories did not
disclose the results of this clinical trial or discouraged others from
publishing its results. In fact, we believe that prompt publication of
all the study data would have been favorable to Northfield
Laboratories.
"We made no effort to discourage the publication of ANH data and
in fact, three publications have resulted from the study with the
fourth expected soon," said Steven A. Gould, MD, Chairman and Chief
Executive Officer of Northfield Laboratories. "We believe that
publishing the full data upon closing the study, would have shown that
PolyHeme could not be isolated as the cause of the observed serious
adverse events."
The ANH trial described in the article as the abdominal aorta
aneurysm trial was conducted in the late 1990s and was a complex study
involving a difficult and unusual procedure in a high risk population
from whom individual consent was obtained. The protocol resulted in
the PolyHeme patients' having 60 percent of their blood volume
withdrawn versus 30 percent in the control group. In keeping with the
protocol, the PolyHeme group also received substantially more fluids
than did the controls resulting in complex issues with fluid
management in those patients. Even so, serious adverse events were not
uniformly observed in the study. In our concurrent trauma trial
PolyHeme was being administered to rapidly bleeding patients in doses
of up to 20 units (or twice the blood volume of an adult) without
these findings. Furthermore, as there was no evidence of ischemia upon
intraoperative EKG studies in the ANH patients, we believe it is
unlikely the outcomes in the ANH trial are due to a pharmacologic
effect of PolyHeme.
Because we experienced difficulty in enrolling the number of
patients required to complete the study in a timely manner, with FDA
approval, we wound down the study over a period of months, not
abruptly as the article states. The trial closed in 2000 and the full
data were reported to the FDA.
Lead ANH trial investigator Edward Norris, MD of Johns Hopkins
University Hospital, will present the full study results at the
Network for the Advancement of Transfusion Alternatives (NATA) meeting
in April 2006. We believe his presentation will substantiate our
conclusions as does our extensive experience with PolyHeme in trauma
settings.
Northfield is currently conducting a national trial with PolyHeme
in the trauma setting. This trial, which began in 2003 was approved by
the FDA and 32 Institutional Review Boards at Level I Trauma Centers
for patient enrollment after they reviewed the protocol and the
results of all previous trials with PolyHeme.
"We believe the markedly different experiences with PolyHeme in
the ANH and trauma trials can be attributed to the entirely different
protocols, settings, and populations in these studies," said Gould.
"To suggest the ANH data were withheld to further the trauma trial is
patently untrue and damaging to both Northfield Laboratories and
PolyHeme."
Every investigator and every IRB at every site involved in the
current trauma trial was fully informed of the results of all of
Northfield's prior trials. Because the trauma trial is being conducted
under a Federal regulation allowing for a waiver of informed consent,
communities participating in the study have been engaged in ongoing
discussions with investigators regarding the trial. Northfield made no
effort to dissuade centers from presenting previous trial information
in any of their community outreach efforts.
The current trauma trial has passed four interim analyses of the
mortality and serious adverse event data by the Independent Data
Monitoring Committee (IDMC) charged with its oversight. The last
review occurred In November 2005 after the first 500 patients had been
enrolled and followed for 30 days. Had a safety issue been identified,
the IDMC would have recommended we either modify the protocol or stop
the study. After each analysis the IDMC recommended that the study
continue without modification as there were no safety reasons to alter
the protocol.
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 in excess of 12 months.
Enrollment is currently underway in a pivotal Phase III trial of
PolyHeme(R) beginning in the pre-hospital setting. For further
information, visit www.northfieldlabs.com.
This press release may contain forward-looking statements
concerning, among other things, Northfield's future business plans and
strategies and clinical and regulatory developments affecting our
PolyHeme(R) red blood cell 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.