Healthcare Industry News: NSCLC
News Release - February 27, 2006
Alfacell Achieves Full Patient Enrollment Milestone for the ONCONASE Phase IIIb Registration Study in Unresectable Malignant MesotheliomaBLOOMFIELD, N.J., Feb. 27 (HSMN NewsFeed) -- Alfacell Corporation (Nasdaq: ACEL ) 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.
About Alfacell Corporation
Alfacell Corporation is a biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for cancer, using its proprietary RNase technology platform. For more information, please visit www.alfacell.com.
This press release includes statements that may constitute "forward-looking" statements, usually containing the words "believe," "estimate," "project," "expect" or similar expressions. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, uncertainties involved in transitioning from concept to product, uncertainties involving the ability of the Company to finance research and development activities, potential challenges to or violations of patents, uncertainties regarding the outcome of clinical trials, the Company's ability to secure necessary approvals from regulatory agencies, dependence upon third-party vendors, and other risks discussed in the Company's periodic filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release.
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