CORRECTING and REPLACING Northfield Laboratories Strongly Disputes Wall Street Journal Story Conclusions
March 20 2006 - 10:35PM
Business Wire
Please replace the release (dated February 22, 2006) with the
following corrected version due to multiple revisions. The
corrected release reads: NORTHFIELD LABORATORIES STRONGLY DISPUTES
WALL STREET JOURNAL STORY CONCLUSIONS Northfield Laboratories
(NASDAQ: NFLD) released the following statement in response to a
Wall Street Journal article on the company published February 22,
2006: The 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patients' having 60 percent of their blood volume withdrawn versus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. Contrary to a
statement in the previous release, Dr. Edward Norris of Johns
Hopkins University School of Medicine has withdrawn as a presenter
of an abstract of the ANH study at the Network for the Advancement
of Transfusion Alternatives (NATA) meeting in April 2006.
Northfield was unable to provide him with access to the entire
database from the study in sufficient time to permit his
preparation for the presentation. Northfield's original press
release dated February 22, 2006, did not mean to imply that Dr.
Norris' presentation was designed to substantiate its conclusions
about the data. 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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