Alfacell: interim phase 3b trial data favors Onconase in treatment for malignant mesothelioma

By Lisa Kerner

Erie, Pa., April 27 - Alfacell Corp. said it has reached 210 of the 316 planned events (deaths) in its confirmatory phase 3b registration trial evaluating Onconase (ranpirnase) as a treatment for unresectable malignant mesothelioma.

The company 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 plus doxorubicin as compared to doxorubicin alone, with a primary endpoint of overall survival.

Alfacell said the overall median survival time favored the Onconase plus doxorubicin treatment group (12 months) over the doxorubicin group (10 months).

At one year, 47% of the Onconase plus doxorubicin-treated patients were alive as compared to 36% of the patients treated with doxorubicin alone.

Onconase inhibits protein synthesis, stops cell cycle proliferation and induces apoptosis, or programmed cell death.

Alfacell is a Bloomfield, N.J., biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for cancer.

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