NoBlood

Jan B. Wade · #1 (**permalink**) 10-14-2004, 12:06 PM

http://money.iwon.com/jsp/nw/nwdt_ge...&cat=PRRELEASE
Northfield Laboratories Inc. Announces Result of Second Interim Analysis of PolyHeme Pivotal Phase III Study Data
Wednesday October 13, 7:00 AM EDT

EVANSTON, Ill., Oct 13, 2004 /PRNewswire-FirstCall via COMTEX/ -- Northfield Laboratories Inc. (NFLD) announced today that the independent data monitoring committee (IDMC) has recommended that the Company's pivotal Phase III trial with PolyHeme(R) continue without modification following the second planned interim analysis of the study. The IDMC stated, "there are no concerns to alter the protocol" after a review of blinded data on mortality and serious adverse events in the first 120 patients enrolled in the study. This is the first time a blood substitute has successfully passed this patient evaluation milestone in a Phase III clinical trial in the high-risk trauma population.

The pivotal Phase III study is designed to evaluate the safety and efficacy of PolyHeme(R), Northfield's human hemoglobin-based oxygen carrier, when administered to patients in hemorrhagic shock following traumatic injury. It is the first study in the United States in which treatment with a blood substitute begins at the scene of injury. Patients are currently being enrolled at Level I trauma centers throughout the United States, with a target enrollment of 720 patients. The primary endpoint is survival at 30 days.

"Northfield has reached another significant milestone in this pivotal trial," said Steven A. Gould, M.D., Chairman and Chief Executive Officer. "We are encouraged by this second positive recommendation of the IDMC, which once again confirms the attention to patient safety that characterizes the efforts of all involved in this complex study. This trial is an important step towards achieving our goal of bringing PolyHeme(R) to market as the first blood substitute approved for use in urgent, life-threatening hemorrhage. We look forward to providing additional updates as the trial progresses."

The IDMC is a group of experts, not associated with Northfield, responsible for periodically evaluating the safety data from the study and making recommendations relating to the continuation or modification of the study to minimize any identified risks to patients. These "interim looks" are defined in the study protocol and take place after 60, 120, 250 and 500 patients are enrolled and followed for a 30-day period to assess survival. The IDMC will review all safety data as the study proceeds, focusing on mortality and serious adverse events. Strict confidentiality of the data is maintained by the IDMC. Northfield will receive a recommendation from the IDMC after each review, but does not have access to the actual data or the deliberations of the IDMC, and will remain shielded from the data until the study is complete. Patients continue to be enrolled in the study while the IDMC conducts its reviews of interim data.