Biotech Values

[St_armands_man]

NFLD strongly disputes WSJ article


http://phx.corporate-ir.net/phoenix.zhtml?c=91374&p=irol-newsArticle&ID=820512&highlight...

Northfield Laboratories Strongly Disputes Wall Street Journal Story Conclusions

EVANSTON, Ill.--(BUSINESS WIRE)--Feb. 22, 2006--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 The protocol resulted in the PolyHeme patients' having 60 percent of their blood volume withdrawn versus 30 percent in the control group.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.