Northfield off on WSJ report

NFLD was off $0.59 to $11.64 on Wednesday after the Wall Street Journal said the company did not publicly disclose results from a Phase III trial in which 10 patients receiving NFLD's PolyHeme blood substitute suffered heart attacks, of whom two died. NFLD confirmed the results of the Acute Normovolemic Hemodilution (ANH) trial of PolyHeme to treat abdominal aortic aneurysm in 152 patients but said full data from the trial were reported to FDA. NFLD disputed the WSJ's claim that it had discouraged publication of the data and added that three publications have resulted from the study, which was ended early in 2000 because of difficulty enrolling patients. NFLD expects to present full data from the ANH trial at the Network for the Advancement of Transfusion Alternatives meeting in April.

NFLD also said it believes the deaths were not related to PolyHeme, but rather were related to the protocol and patient population. The PolyHeme group had 60% of their blood volume withdrawn vs. 30% for control patients. The PolyHeme group also received substantially more fluids, resulting in complex fluid management issues, NFLD said. ...