Northfield Laboratories Strongly Disputes Wall Street Journal Story Conclusions
23 February 2006 - 5:29AM
Business Wire
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their blood volume withdrawn versus 30 percent in the control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.
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