OnconaseTreatment for Malignant Pleural Mesothelioma
Onconase NDA Submission Update
Alfacell Provides Onconase NDA Submission Update - Dec 8, 2008
SOMERSET, N.J., December 05, 2008 /PRNewswire-FirstCall/ -- Alfacell Corporation today reported that the U.S. Food and Drug Administration (FDA) has scheduled a pre-NDA meeting date at the end of January 2009 for discussion of 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. The pre-NDA meeting is an important step to complete prior to the planned submission of the final components of the Onconase rolling NDA for patients that have failed prior chemotherapy. Therefore, the final components of the rolling Onconase NDA will not be finalized until Alfacell receives guidance from the FDA at the pre-NDA meeting. Alfacell expects to provide an update on the planned completion of the rolling NDA within 48 hours of the conclusion of the pre-NDA meeting.
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.
Since receiving the results of this preliminary statistical analysis in late May 2008, the company engaged in an extensive and careful review of the data to submit to the FDA prior to the pre-NDA meeting. While preparations of materials for the pre-NDA meeting have taken more time than expected, by submitting the pre-NDA meeting request on October 3, 2008, Alfacell had anticipated that the pre-NDA meeting would be scheduled no later than mid-December 2008, based on industry guidance published by the FDA. As a result, the end of January 2009 pre-NDA meeting date has affected the company's ability to meet its previous NDA submission target date. The company intends to seek the FDA's permission to complete the submission of the rolling NDA at the pre-NDA meeting. If the FDA grants such permission or accepts the NDA for filing after the submission is completed, no inference can be made concerning the FDA's ultimate decision on whether or not to approve the NDA. It is also possible that the FDA will advise the company at the pre-NDA meeting that the FDA will not allow the company to complete the submission of its NDA.
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 Wendy Lau, 1-212-845-4271,, or investors, Andreas Marathovouniotis ofRusso Partners, +1-212-845-4253, , allof Russo Partners David.Schull@russopartnersllc.com Wendy.Lau@russopartnersllc.com Andreas.Marathis@russopartnersllc.com
Web site: http://www.alfacell.com/
Ticker Symbol: (NASDAQ-NMS:ACEL)
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Posted: December 2008
- Alfacell Provides Onconase NDA Submission Update - Jan 28, 2009 - January 28, 2009
- Alfacell Completes Non-Clinical Section of Rolling NDA for Lead Anticancer Drug Onconase - October 2, 2006