Press Release from Alfacell Corporation
Alfacell Achieves Full Patient Enrollment Milestone for the ONCONASE Phase IIIb Registration Study in Unresectable Malignant Mesothelioma
February 27, 2006
BLOOMFIELD, N.J., Feb. 27 /PRNewswire-FirstCall/ -- Alfacell Corporation (Nasdaq: ACEL - News) today announced that the full enrollment target of 316 patients has been reached for the international, confirmatory Phase IIIb registration trial evaluating ONCONASE® (ranpirnase), the Company's lead investigational drug candidate, as a treatment for unresectable malignant mesothelioma (UMM).
The Company has developed and managed one of the largest UMM clinical programs ever undertaken. Over 600 UMM patients have been enrolled in the ONCONASE UMM 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," stated Kuslima Shogen, Chief Executive Officer of Alfacell.
About the ONCONASE Phase IIIb Registration Study
ONCONASE is being evaluated at over 40 investigator sites across 10 countries in a centrally-randomized, open-label Phase IIIb trial as a treatment for UMM, an asbestos-related cancer that afflicts approximately 10,000 people worldwide -- including 4,000 in the U.S. -- 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. The estimated global UMM market is $300 million.
ONCONASE is a first-in-class therapeutic from Alfacell's proprietary ribonuclease (RNase) technology platform. ONCONASE 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, ONCONASE inhibits protein synthesis, stops cell cycle proliferation, and induces apoptosis (programmed cell death).
ONCONASE has previously been granted Orphan Drug designation from EMEA and TGA (Australia), as well as Fast Track status by the FDA. The latter has enabled the Company to complete and submit sections of the New Drug Application (NDA) on an accelerated, rolling basis.
In addition to the Phase IIIb UMM registration trial, the Company is conducting an ONCONASE Phase I / II trial in Non-Small Cell Lung Cancer (NSCLC). The NSCLC market is expected to exceed $4 billion by 2012.
Also, pre-clinical studies examining ONCONASE conjugates as potential treatments for gliomas and Non-Hodgkins Lymphoma (NHL) are being conducted at Johns Hopkins University and the National Cancer Institute (NCI), respectively.