EVANSTON, Ill.--(BUSINESS WIRE)--March 14, 2006--Northfield Laboratories (Nasdaq: NFLD - News) 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®, for the treatment of urgent, large volume blood loss in trauma and resultant surgical settings. PolyHeme® 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® 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® 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.
Contact: Northfield Laboratories, Evanston Sophia H. Twaddell, 847-864-3500 stwaddell@northfieldlabs.com or Fleishman-Hillard Paula Waters, 847-840-6235 watersp@fleishman.com
Source: Northfield Laboratories
