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Paper in Molecular Cancer Therapeutics Reports that a Novel Combination of Alfacell's ONCONASE(R) and Rosiglitazone Induces a Synergistic Apoptotic Effect in Several Cancer Cell Lines

SOMERSET, N.J., July 21 /PRNewswire-FirstCall/ -- Alfacell Corporation (Nasdaq: ACEL) today announced that a paper published in Molecular Cancer Therapeutics (2008; 7(7):1871-9) reports that a combination of ONCONASE (ranpirnase) and the thiazolidinedione antidiabetic drug rosiglitazone shows a promising effect for cancers with increased expression of PI3K-dependent Fra-1 expression or Survivin.

The paper is the result of NIH-funded in vitro research conducted at the University of Vermont in Burlington, Vt., investigating two known phosphatidylinositol 3-kinase (PI3K) downstream proteins, Fra-1 and Survivin, as potential targets for cancer therapy. The study demonstrated that the combination of ONCONASE and rosiglitazone synergistically decreased cell viability and increased cell apoptosis in several cancer cell lines, including lung, breast, prostate and ovarian, due to decreased Fra-1 and Survivin expression. The results also suggest that combined therapeutic use may overcome the resistance produced in some cancer cells by the activation of survival pathways and their targets. The study concludes the novel drug combination of ONCONASE and rosiglitazone is a promising combination.

"This in vitro study further confirms the previously published in vitro and in vivo studies and demonstrates the potential of ONCONASE for effective use in cancer treatments via multiple molecular mechanisms of action," said Kuslima Shogen, Alfacell's chief executive officer. "Multiple drug resistance is a critical problem in the effective treatment of cancer and this research adds to the previous body of work indicating that ONCONASE could play an important role in treating the disease."


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

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.

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SOURCE Alfacell Corporation
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