Navigation Links
Alfacell Provides ONCONASE(R) NDA Submission Update
Date:12/5/2008

SOMERSET, N.J., Dec. 5 /PRNewswire-FirstCall/ -- Alfacell Corporation (Nasdaq: ACEL) 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.

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 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.

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, 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.

    Media Contact:                      Investor Contact:
    David Schull or Wendy Lau           Andreas Marathovouniotis
    Russo Partners                      Russo Partners
    212-845-4271                        212-845-4253
    David.Schull@russopartnersllc.com   Andreas.Marathis@russopartnersllc.com
    Wendy.Lau@russopartnersllc.com

'/>"/>
SOURCE Alfacell Corporation
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Paper in Molecular Cancer Therapeutics Reports that a Novel Combination of Alfacells ONCONASE(R) and Rosiglitazone Induces a Synergistic Apoptotic Effect in Several Cancer Cell Lines
2. Alfacell Announces ONCONASE(R) Distribution and Marketing Agreement with Megapharm for Israel
3. Alfacell Corporation Announces Preliminary Results From ONCONASE(R) Phase IIIb Clinical Trial
4. Alfacells ONCONASE(R) Shows Potential as Radiation Sensitizer for Lung Cancer Treatment
5. Alfacell Updates Status of ONCONASE(R) Phase III Clinical Program
6. Alfacell Reports Financial Results for First Quarter of Fiscal 2008
7. Alfacell Corporation to Present at UBS Global Life Sciences Conference
8. Alfacell Updates Status of ONCONASE(R) Phase III Clinical Program
9. Paper in International Journal of Oncology Reports Alfacells ONCONASE(R) Suppresses Intracellular Oxidative Stress
10. Sangamo BioSciences Provides Update on Companys 2008 Progress and 2009 Objectives
11. Schering-Plough Provides Update on Boceprevir Clinical Development and Introduces Potent Next-Generation Oral HCV Protease Inhibitor for Treating Patients With Chronic Hepatitis C
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/27/2016)...  Hologic, Inc. (Nasdaq: HOLX ) ... fiscal second quarter ended March 26, 2016.  GAAP ... 41.2%, and non-GAAP diluted EPS of $0.47 increased ... a reported basis, and 6.3% on a constant ... good quarter, highlighted by 14.6% growth in non-GAAP ...
(Date:4/27/2016)... PARIS , le 27 Avril 2016 /PRNewswire/ ... chiffre d,affaires a progressé de +5% sur le ... ventes récurrentes de consommables  Croissance de ... Mauna Kea Technologies (Euronext : ... multidisciplinaire d,endomicroscopie confocale laser, annonce aujourd,hui son chiffre ...
(Date:4/27/2016)... April 27, 2016 Elekta today ... platform will be the focal point of seven scientific ... European Society for Radiotherapy & Oncology, taking place April ... a state-of-the-art radiotherapy system and a high-field MRI scanner ... see the patient,s anatomy in real time. The MR-linac ...
Breaking Medicine Technology:
(Date:5/1/2016)... (PRWEB) , ... May 01, 2016 , ... ... http://www.womensexcellence.com that gives new mothers a better understanding of what to ... to call, · Adjusting to baby postpartum, · The blues and depression, · ...
(Date:4/30/2016)... , ... May 01, 2016 , ... Serenity Recovery, a ... rehabilitation, has produced a new video that focuses on one of the more popular ... sessions and clips from interviews with a participating patients and the Yoga class instructor, ...
(Date:4/30/2016)... ... 30, 2016 , ... Saturday, April 30, marks World Veterinary ... public health. The World Veterinary Association (WVA) and the World Organization for Animal ... education with a One Health focus, which emphasizes how veterinarians pursue continuing education ...
(Date:4/30/2016)... ... April 30, 2016 , ... Orlando-based Maximized Living has selected Dr. ... gold in Rio. Under the care of Maximized Living doctors at the London ... unprecedented showing, Maximized Living is sending the largest contingent of elite chiropractors to Rio ...
(Date:4/29/2016)... ... April 29, 2016 , ... Since launching its annual ... foundation serving the footwear industry, has broken all previous participation records in its ... across 23 states during the months of April and May, the 2016 Footwear ...
Breaking Medicine News(10 mins):