OnconaseTreatment for Malignant Pleural Mesothelioma
Onconase NDA Update
Alfacell Provides Onconase NDA Submission Update - Jan 28, 2009
SOMERSET, N.J., January 27, 2009 /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.
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.
CONTACT: Media, David Schull, +1-212-845-4271,, or Investors, Andreas Marathovouniotis,+1-212-845-4253, , both of RussoPartners, for Alfacell Corporation David.Schull@russopartnersllc.com Andreas.Marathis@russopartnersllc.com
Web site: http://www.alfacell.com/
Ticker Symbol: (NASDAQ-OTCBB:ACEL),(:ACEL.OB)
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Posted: January 2009
- Alfacell Provides Onconase NDA Submission Update - Dec 8, 2008 - December 8, 2008
- Alfacell Completes Non-Clinical Section of Rolling NDA for Lead Anticancer Drug Onconase - October 2, 2006