ALFACELL UPDATES PROGRESS ON MESOTHELIOMA TRIAL

Alfacell has released an update on the progress of its ongoing randomized, multicenter, Phase IIIb study of its lead anti-cancer drug, Onconase (ranpirnase). The trial is evaluating the effectiveness of Onconase plus doxorubicin in improving the survival of patients with unresectable malignant mesothelioma over doxorubicin alone.

"To date, we have accrued more than 360 patients, and are awaiting the 316 events required to trigger the final analysis. We look forward to completing the study and to adhering closely to our desired critical path, which centers on positive results from the final analysis leading to the filing of [a new drug application]," Kuslima Shogen, the company's chairman and CEO, said.

Onconase is a first-in-class therapeutic from Alfacell's proprietary ribonuclease technology platform. The drug has been shown to target tumor cells while sparing normal cells. Onconase is internalized by endocytosis and released into the cytosol of the cancerous cell, where it selectively degrades tRNA beyond repair. In doing so, it inhibits protein synthesis, stops cell cycle proliferation and induces apoptosis (programmed cell death).

The drug has already been granted orphan drug designation in Europe and Australia, as well as fast-track status by the FDA. The company is also conducting Phase I/II trial of Onconase for non-small-cell lung cancer.