Alfacell Corporation (Nasdaq: ACEL - News) today announced that the 210 events (deaths) has been reached in its confirmatory Phase IIIb registration trial evaluating ONCONASE® (ranpirnase), the Company's lead investigational drug candidate, as a treatment for unresectable malignant mesothelioma (UMM).


This number of events represents two-thirds of the required events for the study. The Company has the option to conduct a second interim analysis of the data at any point after 210 events (of the 316 total events planned).


Following the announcement of reaching full patient enrollment (February 2006), the Company today released results from the protocol-specified first interim analysis based on one-third of the required events (105 events of 143 patients) of the study, which evaluates the efficacy, safety and tolerability of the combination of ONCONASE + doxorubicin as compared to doxorubicin alone.


The primary endpoint of the trial is overall survival. The overall median survival time (MST) favored the ONCONASE + doxorubicin treatment group (12 months) over the doxorubicin group (10 months). A two month improvement in median survival had also previously been observed in the Treatment Target Group (TTG) analysis (n=104) from the completed Phase III single agent study that favored the ONCONASE group over doxorubicin group (11.6 months vs. 9.6 months).
The confirmatory registration trial was designed based on the conclusions drawn from the TTG analysis, but powered to reach a statistically significant difference in MST between the ONCONASE + doxorubicin treatment group and the doxorubicin treatment group at 316 events. The first interim analysis was not designed to support filing for marketing approval with the FDA because the data at the time of the

analysis represented only one third of the planned number of events.

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