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 wo
'/>"/>

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:8/22/2014)... Aug. 22, 2014  Cannabis Science, Inc. (OTC: ... drug development and related consulting, is pleased to ... medical cannabis conference taking place at the Faculty ... , on October 22, 2014.  The multilingual conference ... as researchers, health professionals, and patients, to discuss ...
(Date:8/21/2014)... 21, 2014   Memorial Hermann Health System and ... today announced a new partnership to provide a new level ... care centers in the greater Houston ... become the exclusive provider of professional breast radiology services for ... Memorial City, The Woodlands , Northeast, Southwest ...
(Date:8/21/2014)... , Aug. 21, 2014  Publicis Groupe customer ... , Managing Partner and Healthcare Industry Group Leader, has ... which recognizes the most inspiring people in the life-sciences ... in research and development, marketing, technology, creativity, strategy and ... 2006 as a partner in its leading Rosetta Consulting ...
Breaking Medicine Technology:Cannabis Science, Inc. (CBIS) to Sponsor 3rd International Conference on Cannabinoids in Medicine in October 2014 in Strasbourg, France 2Cannabis Science, Inc. (CBIS) to Sponsor 3rd International Conference on Cannabinoids in Medicine in October 2014 in Strasbourg, France 3Memorial Hermann, MD Anderson join forces to provide enhanced breast imaging services throughout the Greater Houston Region 2Memorial Hermann, MD Anderson join forces to provide enhanced breast imaging services throughout the Greater Houston Region 3Memorial Hermann, MD Anderson join forces to provide enhanced breast imaging services throughout the Greater Houston Region 4Shannon Hartley Shines in PharmaVOICE 100 2
... 13 Pacific Bridge Medical, a leading Asia medical consulting firm, ... 26, 2010 at 11am EDT . , ... Taiwan is the sixth largest pharmaceutical market in the Asia Pacific ... health care system. This webcast will give an overview of Taiwan and ...
... May 13 Omeros Corporation (Nasdaq: ... based on successful preclinical studies, the Company has selected ... has initiated the cGMP manufacturing development process in preparation ... proprietary, fully human, monoclonal MASP-2 antibodies shut down the ...
Cached Medicine Technology:Pacific Bridge Medical to Host Taiwan Drug Registration Webinar 2Omeros Selects Clinical Candidate for MASP-2 Program With Potential Applicability to Multiple Inflammatory Disorders 2Omeros Selects Clinical Candidate for MASP-2 Program With Potential Applicability to Multiple Inflammatory Disorders 3Omeros Selects Clinical Candidate for MASP-2 Program With Potential Applicability to Multiple Inflammatory Disorders 4
(Date:8/22/2014)... iFitDress.com, a well-known wedding dress manufacturer and retailer, has ... . In addition to this, the company’s sales representative ... with low shipping fees. , He says proudly, ... gowns. In our online store, there are thousands of ... What’s more, all of them are extremely beautiful. Most ...
(Date:8/22/2014)... Medicine team has found that targeted automated alerts ... infections in hospital patients with urinary catheters. In ... simplified, the rate of improvement dramatically increased. , ... need urinary catheters in the first place and ... catheters that have not been removed within a ...
(Date:8/22/2014)... 22, 2014 As the controversy ... ) in uterine surgeries continues to grow, Bernstein ... have decided to limit coverage of uterine morcellation. ... Blue Cross-Blue Shield of Massachusetts will no longer ... morcellation as of September 1, 2014. Other insurers ...
(Date:8/22/2014)... August 22, 2014 Beat Eczema ... they can use natural methods to completely cure the ... the attention of Shane Michaels, prompting an investigative review. ... affects the skin, it can still be extremely debilitating ... Michaels. “The intense itching and pain that it causes ...
(Date:8/22/2014)... the first time an oncogenic somatic mutation at amino ... has been identified in small cell lung cancer (SCLC) ... cell lines produced increased intracellular signaling and cell growth. ... cancer representing 15% of all lung cancers and is ... lung cancer, has been extensively examined for genomic alterations ...
Breaking Medicine News(10 mins):Health News:Discounted Wedding Gowns For Sale At Leading Online Shop iFitDress.com 2Health News:Penn study: Electronic alerts significantly reduce catheter-associated urinary tract infections 2Health News:Penn study: Electronic alerts significantly reduce catheter-associated urinary tract infections 3Health News:As Power Morcellator Controversy Grows, Bernstein Liebhard LLP Comments on Massachusetts Insurers’ Plans to Limit Coverage of Uterine Morcellation 2Health News:As Power Morcellator Controversy Grows, Bernstein Liebhard LLP Comments on Massachusetts Insurers’ Plans to Limit Coverage of Uterine Morcellation 3Health News:As Power Morcellator Controversy Grows, Bernstein Liebhard LLP Comments on Massachusetts Insurers’ Plans to Limit Coverage of Uterine Morcellation 4Health News:Beat Eczema: Review Exposes Susan Clark’s Guide to Curing Eczema Naturally 2Health News:Novel oncogenic RET mutation found in small cell lung cancer 2
... to gather at the American Academy, of Pain Management,s 18th Annual ... ... Sept. 26 Pain is the number one,public health problem in ... Center for Health Statistics. The,number of people living with pain is ...
... favor of health insurance for low-income ... ... joined with a bi-partisan coalition of his colleagues today,and voted in favor ... I have been a supporter of both The Children,s Health,Insurance Program (CHIP) ...
... relax is at your fingertips, SAN DIEGO, Sept. ... -- Personal Input Pod(TM) -- a revolutionary biosensor that,helps ... applications that run on,Bluetooth(TM) enabled devices such as mobile ... of a unique stress management solution. It is,highly portable, ...
... of Cancer Care in, America; Cancer ... HOUSTON, Sept. 25 US Oncology, the nation,s,leading ... today expressed "deep concern" over a letter released ... (CMS) -- the agency which,manages the nation,s Medicare ...
... Supports Congressional Black Caucus,s ... Call to Action, ... today,s release of "We,re the,Ones We,ve Been Waiting For," its latest report ... doing about it. AIDS Action,Council also welcomes and supports the Call to ...
... State Funding, WOODLAND, Calif., Sept. 25 Homecare ... to increase funding for In-Home,Supportive Services, in order to ... people with disabilities. Workers represented by SEIU United ... a new contract to cover the,1,300 homecare workers in ...
Cached Medicine News:Health News:Effective Pain Management Requires an Interdisciplinary Approach 2Health News:Effective Pain Management Requires an Interdisciplinary Approach 3Health News:Effective Pain Management Requires an Interdisciplinary Approach 4Health News:PIP - A Revolution in Stress Management 2Health News:PIP - A Revolution in Stress Management 3Health News:Cancer Doctors Across America 'Stunned' at Government's Ruling Restricting Anemia Management Protocols for Cancer Patients, Call Ruling 'Interference' in Practice of Medicine 2Health News:Cancer Doctors Across America 'Stunned' at Government's Ruling Restricting Anemia Management Protocols for Cancer Patients, Call Ruling 'Interference' in Practice of Medicine 3Health News:AIDS Action Council Praises Release of Latest State of AIDS in Black America Report 2Health News:Homecare Workers to Supervisors: Preserve Care of our Most Vulnerable 2
... 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 ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... 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 ...
Medicine Products: