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Northfield Laboratories Reports Results of Pivotal Phase III Trauma,Study

the PolyHeme group, and all patients who did not receive any PolyHeme were analyzed in the control group. Although the AT population was pre-specified for safety rather than efficacy, it provides a meaningful opportunity to assess mortality as well.

PP Population

The PP population is comprised of the 586 patients both appropriately randomized and correctly treated. The PP population does not include 128 patients who had major protocol violations related to eligibility or treatment regimen. Since the PP patients were treated exactly as specified in the protocol, Northfield believes the PP population represents the clearest opportunity to assess a treatment effect.

In the primary MITT population, the upper limit of the confidence interval was 7.65%. In the AT population, the upper limit was 7.06%. In the PP population, the upper limit was 6.29%. The data are shown in Table 1. -0-



                               TABLE 1

                           DAY 30 MORTALITY



                           PolyHeme         Control        Upper Limit

                          (deaths/N)   %   (deaths/N)  %

------------------------- ---------- ----- ---------- ---- -----------

MITT                       47/350    13.4   35/364    9.6     7.65%

------------------------- ---------- ----- ---------- ---- -----------

AT                         46/349    13.2   36/365    9.9     7.06%

------------------------- ---------- ----- ---------- ---- -----------

PP                         31/279    11.1   28/307    9.1     6.29%

------------------------- ---------- ----- ---------- ---- -----------

Secondary efficacy endpoints of the study included Day 1 mortality (Table 2), the incidence of multiple organ failure, the use of donated blood through Day 1, and an analysis of mortality by the mechanism of injury (blunt versus penetrating trauma). The incidence of transfusion of donated blood was significantly lower in the PolyHeme group at 41% than
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