Paper In Cell Cycle Reports Alfacell's ONCONASE(R) Targets SiRNA

Main Category: Cancer / Oncology
Also Included In: Biology / Biochemistry;  Clinical Trials / Drug Trials;  Asbestos / Mesothelioma
Article Date: 10 Oct 2008 - 0:00 PST

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Alfacell Corporation (Nasdaq: ACEL) announced that a paper published in Cell Cycle (2008; Vol. 7, Issue 20) reports that ONCONASE (ranpirnase) targets small interfering RNA (siRNA), likely within the RNA-induced silencing complex (RISC) of the RNA interference (RNAi) mechanism.

The paper is the result of research conducted by collaborators at the Brander Cancer Research Institute and Department of Pathology at New York Medical College and Alfacell. The study demonstrated that silencing the glyceraldehyde 3-phosphate dehydrogenase (GAPDH) gene (an abundant and ubiquitously expressed housekeeping gene) in human lung adenocarcinoma A549 cells by siRNA was effectively prevented by ONCONASE. While transfection of cells with GAPDH siRNA reduced expression of this protein by nearly 70 percent, the expression was restored in the cells exposed to ONCONASE for 48 or 72 hours. The data thus provide evidence that one of the targets of ONCONASE (ranpirnase) is siRNA.

"This data provide further evidence of the impact of ONCONASE on the RNAi mechanism," said Kuslima Shogen, Alfacell's chief executive officer. "Furthermore, the data may provide the explanation for the preferential effectiveness of ONCONASE toward tumor cells as well as its ability to sensitize cells to other antitumor agents. As seen in our Phase III clinical trial results, ONCONASE has demonstrated significant efficacy in patients with malignant mesothelioma that failed prior chemotherapy."

About ONCONASE(R)

ONCONASE is a first-in-class therapeutic 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 sparing normal cells. ONCONASE triggers apoptosis, the natural death of cells, via multiple molecular mechanisms of action.

Alfacell has licensed the U.S. commercial rights for ONCONASE to Strativa Pharmaceuticals, a division of Par Pharmaceutical, 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, GENESIS Pharma, S.A. for Southeastern Europe, and Megapharm Ltd. for Israel.

ONCONASE has been granted fast track status and orphan-drug designation for the treatment of malignant mesothelioma by the FDA. Additionally, ONCONASE has been granted orphan-drug designation in the European Union and Australia.

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-stage clinical trials. The product candidate, ONCONASE, is an 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 diseases. Alfacell has completed Phase III clinical trials of ONCONASE in unresectable malignant mesothelioma and, in addition to ongoing efforts to complete the related rolling New Drug Application, Alfacell is currently planning for Phase II clinical trials in other oncology indications. For more information, visit http://www.alfacell.com.

Safe Harbor

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, uncertainty whether the clinical trial results will allow the company to complete submission of a New Drug Application and if a New Drug Application submission is completed, uncertainty whether FDA will file or approve such application, 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 or differences of opinion in interpreting the results of clinical trials, the company's ability to secure necessary approvals from regulatory agencies, dependence upon third-party vendors, the company's ability to timely regain its compliance with NASDAQ continued listing standards and maintain such compliance, 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.

Alfacell Corporation
http://www.alfacell.com