Navigation Links
Alfacell Provides ONCONASE(R) NDA Submission Update
Date:1/27/2009

SOMERSET, N.J., Jan. 27 /PRNewswire-FirstCall/ -- Alfacell Corporation (OTC Bulletin Board: ACEL) 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.

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                         Andreas Marathovouniotis
    Russo Partners                       Russo Partners
    212-845-4271                         212-845-4253
    David.Schull@russopartnersllc.com    Andreas.Marathis@russopartnersllc.com


'/>"/>
SOURCE Alfacell Corporation
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. Alfacells ONCONASE(R) and R-Amphinase Show Anti-Tumor Activity in Chronic Lymphocytic Leukemia and Acute Myeloblastic Leukemia Cells
2. Alfacell Receives Going Concern Audit Opinion
3. Alfacell Reports Fiscal Fourth Quarter and Full Year 2008 Financial Results
4. Paper in Cell Cycle Reports Alfacells ONCONASE(R) Targets siRNA
5. Alfacell Hires Advisors to Advance Strategic Alternatives
6. Alfacell Receives NASDAQ Delisting Letter
7. Alfacell Receives NASDAQ Non-Compliance Notification
8. Alfacell Reports Financial Results for Third Quarter of Fiscal 2008
9. Alfacell Announces Retirement of Chief Executive Officer
10. Alfacell Reports Financial Results for Second Quarter of Fiscal 2008
11. Alfacell to Host Fiscal Second Quarter 2008 Financial Results Conference Call and Webcast
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/29/2016)... ... ... Intelligent Implant Systems announced today that the two-level components for the Revolution™ ... States. These components expand the capabilities of the system and allow Revolution™ to ... of 2015, the company has seen significant sales growth in 1Q 2016, and the ...
(Date:4/28/2016)... , April 28, 2016 ... company reports the Company,s CEO  was featured in ... Accelerators Enter When VCs Fear To Tread: ... Leader magazine is an essential business ... everything from emerging biotechs to Big Pharmas. Their ...
(Date:4/28/2016)... York, NY (PRWEB) , ... April 28, 2016 ... ... QuickSTAT has made significant investments in recruiting top industry experts, and expanding its ... Platform, which provides industry-leading tools for clients to manage their clinical trial projects. ...
(Date:4/27/2016)... ... , ... Shimadzu Scientific Instruments (SSI) will be showcasing a ... and Expo. Shimadzu’s high-performance instruments enable laboratories to test cannabis products for potency, ... by booth 1021 to learn how Shimadzu’s instruments can help improve QA/QC testing, ...
Breaking Biology Technology:
(Date:3/22/2016)... PUNE, India , March 22, 2016 ... new market research report "Electronic Sensors Market for ... Fingerprint, Proximity, & Others), Application (Communication & ... and Geography - Global Forecast to 2022", ... consumer industry is expected to reach USD ...
(Date:3/18/2016)... , March 18, 2016 --> ... of Biometrics, ICT, Manned & Unmanned Vehicles, Physical infrastructure and ... security companies in the border security market and the continuing ... and Europe has led visiongain to ... improved success. --> defence & security companies ...
(Date:3/15/2016)... , March 15, 2016 Yissum Research ... the technology-transfer company of the Hebrew University, announced today ... remote sensing technology of various human biological indicators. Neteera ... $2.0 million from private investors. ... on the detection of electromagnetic emissions from sweat ducts, ...
Breaking Biology News(10 mins):