Northfield Laboratories Statement Regarding Its Pivotal Phase III Trial
March 14 2006 - 8:16PM
Business Wire
Northfield Laboratories (Nasdaq: NFLD) released the following
statement today in response to news reports that Senator Charles
Grassley (R-Iowa) has raised specific questions about the
Northfield trauma trial research protocol, in particular, two
aspects of the current PolyHeme study: -- Whether or not the
protocol meets the requirements for 21 CFR 50.24 waiver of informed
consent; and -- Whether or not it is ethical to continue infusion
of PolyHeme in the hospital setting where blood is available
Northfield is committed to conducting its pivotal Phase III study
with the utmost concern for patient safety. We believe the protocol
is appropriate to evaluate a new therapy with potential life-saving
capability addressing a critical, unmet clinical need. The study
meets the criteria set forth in 21 CFR 50.24; we have adhered
scrupulously to the rule. This federal regulation was issued in
1996. It allows a waiver of informed consent when patients are in a
life-threatening situation, when obtaining individual informed
consent is impossible, and when current therapy is unproven or
unsatisfactory. The most critical stipulation is that there is the
potential for direct benefit to the patients enrolled, which FDA
has interpreted to mean survival benefit. Our study meets these
criteria. FDA authorized the study to proceed under 21 CFR 50.24 in
March 2003. Thirty-two Institutional Review Boards at Level I
trauma centers have reviewed the study protocol and Investigator's
Brochure that summarize all prior studies, conducted community
consultation and public disclosure activities, and approved patient
enrollment. A few sites recently suspended patient enrollment
temporarily while reviewing their activities. Three are once again
enrolling. The study is based on two potential life-saving
benefits. The first is starting infusion of an oxygen-carrying
fluid at the scene of injury and continuing during transport to the
hospital. Because blood is not routinely carried in ambulances,
PolyHeme represents a potential improvement over the current
standard of care. The second opportunity is the potential to
improve the outcome associated with the use of donated blood in the
early hospital period in critically injured patients. Although
blood is the current standard of care, there is a growing body of
scientific evidence pointing to the adverse immunomodulatory
effects of early blood transfusion in trauma patients, specifically
the incidence of multiple organ failure and the resultant
associated mortality. There are also published data indicating that
these same effects may not occur with PolyHeme. Thus while it is
true that blood is available in the hospital, it may not be the
optimal treatment for the early care of trauma, and PolyHeme is
being evaluated as a potential better alternative. This is the
scientific and ethical basis for continuing treatment with PolyHeme
for up to 12 hours following injury or a dose of six units as
approved by the 32 participating IRBs. Special safeguards are in
place to protect patients enrolled in the study. An Independent
Data Monitoring Committee was established to review the safety data
from the study at four pre-specified numbers of patients enrolled.
The IDMC recently reiterated its recommendation to complete the
trial based on four separate reviews of mortality and adverse event
data from the first 500 patients enrolled. The IDMC issued the
following statement: "As has been reported to Northfield
Laboratories regarding the final assessment of the interim data,
including 500 randomized patients, there were no statistically
significant trends or safety issues identified to warrant
modification or other changes in the current protocol and patient
recruitment. The IDMC conclusion is that completion of the trial is
appropriate with completion of datasets and final analysis
indicated." Although the foregoing information has been widely
disseminated, what may be less well understood is the fact that
defined procedures are in place for notification of enrollment at
the earliest feasible opportunity. As specified in the protocol,
once the patient arrives at the hospital, the investigator and
study staff, along with hospital personnel, make rigorous attempts
to contact a legally authorized representative or family member if
the patient remains incapacitated. Ideally, during this period, the
patient will stabilize and have the ability to review the informed
consent document and study procedures and make a decision regarding
further participation or discontinuation in the study. If a patient
is enrolled in the study under provisions for exception from
informed consent requirements, contact with a legally authorized
representative or family member is to be attempted at least: --
Every 30 minutes for the first two hours; then -- Every one hour
through 12 hours postinjury, then -- Twice daily through Day 7,
then -- Once weekly through Day 30, if not previously accomplished.
Northfield is confident that its protocol meets the criteria for an
exception from the requirement for informed consent. As is the case
with all studies conducted under the waiver regulation, special
safeguards are in place to protect patients enrolled in this study.
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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