Alfacell completes enrollment for Onconase phase 3b registration study

By Elaine Rigoli

Tampa, Fla., Feb. 27 - Alfacell Corp. announced Monday that it has reached a full enrollment target of 316 patients for the international, confirmatory phase 3b registration trial evaluating Onconase (ranpirnase), the company's lead investigational drug candidate, as a treatment for unresectable malignant mesothelioma (UMM).

Alfacell said it has enrolled more than 600 patients throughout the duration of the study, including newly diagnosed and refractory patients treated with Onconase as a single agent and in combination with doxorubicin.

"We are pleased to have achieved this important milestone ahead of schedule and look forward to completion of all other regulatory requirements for the marketing approval of Onconase in the U.S., E.U. and other markets," chief executive officer Kuslima Shogen said in a statement.

Onconase is being evaluated at more than 40 investigator sites across 10 countries in a centrally randomized, open-label phase 3b trial as a treatment for UMM, an asbestos-related cancer that afflicts about 10,000 people worldwide, including 4,000 in the United States, each year.

The study is being conducted to determine whether survival is prolonged in UMM patients treated with Onconase in combination with doxorubicin compared to doxorubicin alone, according to a company news release.

The company said the estimated global UMM market is $300 million.

Onconase has previously been granted orphan drug designation from the European Medicines Agency and Therapeutic Goods Administration in Australia, as well as fast-track status by the Food and Drug Administration. The latter has enabled the company to complete and submit sections of the New Drug Application on an accelerated, rolling basis, the release said.

Alfacell is a biopharmaceutical company based in Bloomfield, N.J.

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