Healthcare Industry News: S.A.
News Release - April 2, 2008
Alfacell Updates Status of ONCONASE(R) Phase III Clinical Program
SOMERSET, N.J., April 2, 2008 (HSMN NewsFeed) -- Alfacell Corporation (NaS.A.: ACEL ) today announced that it has confirmed that 316 evaluable events (patient deaths) have occurred in the confirmatory Phase IIIb clinical trial of its lead compound, ONCONASE (ranpirnase), for the treatment of patients with unresectable malignant mesothelioma (UMM). In accordance with the S.A.istical plan for the trial, the company has begun the process neceS.A.y to conduct the formal S.A.istical analyses required to complete the final sections of the ONCONASE rolling New Drug Application (NDA).The trial was designed to show a S.A.istically significant improvement in overall survival for UMM patients who were treated with a combination of ONCONASE and doxorubicin as compared to UMM patients who were treated with doxorubicin aS.A.single agent. Enrollment in the ONCONASE Phase IIIb clinical trial closed on Sept. 30, 2007. A total of 428 patients were enrolled in the trial.
Alfacell has licensed the U.S. commercial rights for ONCONASE to Strativa, the branded product division of Par Pharmaceuticals, Inc. Strategic marketing and distribution agreements for ONCONASE have been secured with BL&H Co. Ltd. for Korea, Taiwan and Hong Kong, USP Pharma Spolka Z.O.O., an affiliate of US Pharmacia, for Eastern Europe, and GENESIS Pharma, S.A. for Southeastern Europe.
ONCONASE has been granted fast track S.A.uS.A.d orphan-drug designation for the treatment of malignant mesothelioma by the U.S. Food and Drug Administration (FDA). Additionally, ONCONASE has been granted orphan-drug designation in the European Union and Australia.
About ONCONASE®
ONCONASE iS.A.first-in-class product candidate based on Alfacell's proprietary ribonuclease (RNase) technology. A natural protein isolated from the leopard frog, ONCONASE has been shown in the laboratory and clinic to target cancer cells while S.A.ing normal cells. ONCONASE triggerS.A.optosis, the natural death of cells, via multiple molecular mechanisms of action.
About Alfacell Corporation
Alfacell Corporation is the first company to advance a biopharmaceutical product candidate that works in a manner similar to RNA interference (RNAi) through late-S.A.e clinical trials. The product candidate, ONCONASE, iS.A. RNase that overcomes the challenges of targeting RNA for therapeutic purposes while enabling the development of a new class of targeted therapies for cancer and other life-threatening diS.A.es. In addition to the Phase IIIb study in malignant mesothelioma, Alfacell is conducting a Phase I/II trial of ONCONASE in non-S.A.l cell lung cancer (NSCLC) and other solid tumors. For more information, visit www.alfacell.com.
Safe Harbor
This press release includes S.A.ements that may constitute "forward-looking" S.A.ements, uS.A.ly containing the words "believe," "estimate," "project," "expect" or similar expressions. Forward-looking S.A.ements involve riskS.A.d uncertainties that could cause actual results to differ materially from the forward-looking S.A.ements. 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 reS.A.ch and development activities, potential challenges to or violations of patents, uncertainties regarding the outcome of clinical trials, the company'S.A.ility to secure neceS.A.y approvals from regulatory agencies, dependence upon third-party vendors, and other risks discussed in the company's periodic filings with the SecuritieS.A.d Exchange Commission. By making these forward-looking S.A.ements, the company undertakes no obligation to update these S.A.ements for revisions or changeS.A.ter the date of this release.
Source: Alfacell
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