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

uld 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 biopharmace
'/>"/>

SOURCE Alfacell Corporation
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

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:7/28/2014)... SAN FRANCISCO , July 28, 2014 /PRNewswire/ ... that it has received the Get With The ... quality improvement measures outlined by the American Heart ... patients. Stroke is the number four cause of ... in the United States , ...
(Date:7/28/2014)... Anthera Pharmaceuticals, Inc. (NASDAQ: ANTH ), today announced ... June 30, 2014. Net loss for the ... to $8.3 million for the same period in 2013. The ... decrease in interest expense in the current period.  ... 2014 was $15.2 million, compared with net loss of $15.9 ...
(Date:7/28/2014)... 2014 STAAR Surgical Company (NASDAQ: ... implantable lenses and delivery systems for the eye has ... conference call with investors to July 31, 2014 at ... rescheduled the release date and conference call to enable ... Hideo Watanabe , President of STAAR Japan, who passed ...
Breaking Medicine Technology:Dignity Health St. Mary's Medical Center Honored with Quality Achievement Award for Stroke Care 2Dignity Health St. Mary's Medical Center Honored with Quality Achievement Award for Stroke Care 3Anthera Pharmaceuticals Reports 2014 Second Quarter Financial Results and Operational Update 2Anthera Pharmaceuticals Reports 2014 Second Quarter Financial Results and Operational Update 3Anthera Pharmaceuticals Reports 2014 Second Quarter Financial Results and Operational Update 4Anthera Pharmaceuticals Reports 2014 Second Quarter Financial Results and Operational Update 5Anthera Pharmaceuticals Reports 2014 Second Quarter Financial Results and Operational Update 6Anthera Pharmaceuticals Reports 2014 Second Quarter Financial Results and Operational Update 7STAAR Surgical Moves Second Quarter Earnings Release and Conference Call One Day to July 31 2
... , THE WOODLANDS, Texas , Jan. 28 ... treatment and research network, will announce its operating results for the ... Feb. 25, 2010 . , A conference call and simultaneous webcast ... following a distribution of the earnings release. Additional information will be ...
... , TORONTO , Jan. 28 ... appointment of Patricia Archambault as vice president, healthcare ... overseeing key client relationships and healthcare team activities in the ... The vice president, healthcare, role is new for the ...
Cached Medicine Technology:US Oncology to Report 2009 Fourth Quarter and Year End Operating Results 2MS&L Appoints Patricia Archambault as Vice President, Healthcare in Montreal 2MS&L Appoints Patricia Archambault as Vice President, Healthcare in Montreal 3
(Date:7/28/2014)... July 28, 2014 A lush green lawn ... during the summer. However, the summer heat, lack of rain, ... become brown, weak and unhealthy. The Grounds Guys recommends these ... Mow a lawn once a week and set the height ... This protects the grass roots from heat and allows roots ...
(Date:7/28/2014)... (PRWEB) July 28, 2014 Camp ... a new camp property in Cornville, AZ. The ... ill children with the opportunity to attend medically ... and families. The organization offers a variety of ... with chronic and life threatening illnesses including: Illness ...
(Date:7/28/2014)... 2014 A January 2013 study ... intake in those who were self-diagnosed gluten-intolerant yielded little ... nutrition for San Diego health and wellness retreat ... for those who are unclear about the role gluten ... is a protein, found in wheat, barley, rye, and ...
(Date:7/28/2014)... July 28, 2014 UHY LLP, a ... latest edition of UHY International Business – Issue 29. ... members, on the most current business challenges and key ... Issue 29 covers the following topics:, , ... sectors will thrive over the next five years? Where ...
(Date:7/28/2014)... WI (PRWEB) July 28, 2014 Quincy ... Prevagen® , is pleased to announce the release of ... by company president and co-founder Mark Underwood. , The ... health information, offering useful techniques for readers to improve ... as an unavoidable conclusion, The Brain Health Guide provides ...
Breaking Medicine News(10 mins):Health News:Nurturing Lawns in the Summer Heat: The Grounds Guys® Offers Tips on Caring for Lawns This Summer 2Health News:Camp Soaring Eagle Announces New Camp Site 2Health News:Camp Soaring Eagle Announces New Camp Site 3Health News:VeraVia Explains the Basics of Gluten-Intolerance Following Industry Study 2Health News:VeraVia Explains the Basics of Gluten-Intolerance Following Industry Study 3Health News:Uhy International Business Issue 29 Now Available 2Health News:Uhy International Business Issue 29 Now Available 3Health News:Quincy Bioscience Launches the Fourth Edition of The Brain Health Guide 2
... Canadian scientists has revealed that vaccines that contain ... ,McGill University Health Center scientists examined patterns between ... and reported their findings in the journal Pediatrics. ... were actually higher in children given shots after ...
... India Institute of Medical Sciences remained crippled today as ... the move to sack its Director P Venugopal//. ... since last evening as resident doctors and faculty of ... headed by Union Health Minister A Ramadoss recommended the ...
... ,The meeting of provincial health ministers to approve a ... the need for financial// help of the federal government ... ,The meeting in Fredericton was planned to be conducted ... reluctant to give any more than what was agreed ...
... infertility and needing cancer therapy, it was difficult to ... removed from their normal environment//. ,But a ... a new technology (i.e.) a three-dimensional culture system that ... helped maintain a normal connection between follicle and egg ...
... it was found that teenagers who were taking cannabis on ... in their life. ,Teenagers turn in to heroin ... that they derive by taking these drugs. Cannabis is ... person to get exposed to other hard drugs. Adolescents become ...
... – involved in tumor-suppression or cell-proliferation-suppressing function resulted in ... blood sugar// regulation - researchers at the University of ... menin gene (Men1) mutation can lead to a genetic ... this discovery also has implications for diabetes treatment. ...
Cached Medicine News:Health News:Clement Urged to Plot a National Pharmaceutical Strategy 2Health News:A three-dimensional Culture System ensures Female Fertility 2Health News:Menin Gene Mutation made Insulin Secreting Cells to Proliferate 2
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
Medicine Products: