Alfacell Provides ONCONASE(R) NDA Submission Update
Published: Jan 28, 2009
SOMERSET, N.J., Jan. 27 /PRNewswire-FirstCall/ -- Alfacell Corporation today reported that it has conducted a pre-NDA meeting with the U.S. Food and Drug Administration (FDA) to discuss the company's planned submission of the final components of the ONCONASE rolling New Drug Application (NDA) for the treatment of unresectable malignant mesothelioma (UMM) patients. At the pre-NDA meeting, the FDA provided guidance to the company recommending that an additional clinical trial be conducted in UMM patients that have failed one prior chemotherapy regimen, prior to submitting a NDA.
As the company has previously reported, the results of the preliminary statistical analysis of the data from the confirmatory Phase IIIb clinical trial for ONCONASE in patients suffering from UMM did not meet statistical significance for the primary endpoint of survival in UMM. However, a statistically significant improvement in survival was seen in the treatment of UMM patients who failed one prior chemotherapy regimen, a pre-defined primary data set for this sub-group of patients in the trial, which represents a currently unmet medical need.
The company's current financial situation does not allow it to pursue additional clinical trials until other sources of capital are secured. The company will effect a reduction in force on January 30, 2009 and otherwise reduce its operations to the minimum sustainable level required to pursue strategic alternatives and additional capital. Based upon these actions the company expects that its current cash reserves will enable it to maintain its reduced operations through December 2009. The company intends to continue to explore strategic alternatives and additional capital. Additionally, the company's board of directors has agreed to forgo cash compensation effective as of January 1, 2009.
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 Megapharm Ltd. for Israel, 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 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. For more information, 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, 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, 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.
CONTACT: Media, David Schull, +1-212-845-4271,
David.Schull@russopartnersllc.com, or Investors, Andreas Marathovouniotis,
+1-212-845-4253, Andreas.Marathis@russopartnersllc.com, both of Russo
Partners, for Alfacell Corporation
Web site: http://www.alfacell.com/