Navigation Links
Vion Pharmaceuticals' New Drug Application for Onrigin(TM)Accepted For Review by the FDA
Date:4/16/2009

NEW HAVEN, Conn., April 16 /PRNewswire-FirstCall/ -- Vion Pharmaceuticals, Inc. (OTC Bulletin Board: VION) today announced that the New Drug Application (NDA) for its lead oncology therapeutic Onrigin (laromustine) Injection has been accepted for review by the U.S. Food and Drug Administration (FDA).

The Company had previously announced the filing of the NDA with the FDA in February 2009. The NDA presents data for Onrigin as a single agent for remission induction treatment for patients sixty years of age or older with de novo poor-risk acute myeloid leukemia (AML). The NDA is based on the results of an international multi-center pivotal Phase II trial of 85 patients sixty years of age or older with de novo poor-risk AML, supplemented by data from 55 patients in a previous Phase II trial in elderly AML. Eighty-six percent of these 140 patients had two or more risk factors that predicted for a poor prognosis.

Alan Kessman, Chief Executive Officer, commented, "Acceptance of our NDA filing for review is an important milestone for Vion. We will continue to work closely with the FDA on the filing with the objective of achieving approval for Onrigin in its first indication in the United States."

About Vion Pharmaceuticals

Vion Pharmaceuticals, Inc. is committed to extending the lives and improving the quality of life of cancer patients worldwide by developing and commercializing innovative oncology therapeutics. Vion has two agents in clinical trials, Onrigin (laromustine) Injection and Triapine(R). The FDA is reviewing a New Drug Application for Onrigin for remission induction treatment for patients sixty years of age or older with de novo poor-risk AML. Triapine(R), a potent inhibitor of a key step in DNA synthesis, is being evaluated in clinical trials sponsored by the National Cancer Institute. For additional information on Vion and its product development
'/>"/>

SOURCE Vion Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine news :

1. Generic Pharmaceuticals Offer Exciting Growth Opportunities in Tanzania, Reveals Frost & Sullivan
2. Alseres Pharmaceuticals, Inc. Receives Notice of De-Listing of Its Securities for Failure to Regain Compliance with Continued Listing Requirements
3. Amylin Pharmaceuticals to Webcast First Quarter Results
4. MonoSol Rx and Strativa Pharmaceuticals Submit New Drug Application for Ondansetron Orally Dissolving Film Strip
5. AUDIO from Medialink and Forest Pharmaceuticals: FDA Approves Lexapro for Major Depressive Disorder in Adolescents
6. Sigma-Tau Pharmaceuticals and Danisco BioActives Announce Partnership Agreement to Develop Drug Candidate for Prevention of Necrotizing Enterocolitis
7. Avineuro Pharmaceuticals, Inc. Announces Beginning of Phase I Clinical Studies of AVN-101, Potent Small Molecule for Treatment of Alzheimers Disease.
8. Jazz Pharmaceuticals, Inc. Announces Board of Directors and Management Changes
9. Genesis Pharmaceuticals Affirms Operating Income Guidance, Adjusts Revenue Guidance for Fiscal 2009
10. Novavax Announces Closing of $11 Million Common Stock Sale to Subsidiary of Cadila Pharmaceuticals
11. Sunesis Pharmaceuticals Announces Up To $43.5 Million Financing
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/19/2014)... 2014 Are you tired of having ... with seasonal allergies or sinus congestion? Fortunately, an inventor ... , She conceived of Nose Pal to avoid ... nose in public. Since it prevents nasal drip and ... conditions, particularly when cooking or working closely with others. ...
(Date:9/19/2014)... (HealthDay News) -- As kids transition from elementary to ... according to a recent study. But the ... found that verbal and physical bullying declines as students ... and prevention strategies must address all types of bullying ... girls, the researchers said. The study was published recently ...
(Date:9/19/2014)... Phoenix, AZ (PRWEB) September 19, 2014 Hastings ... over 30 years in the industry, announces a record number ... firm handles a wide variety of serious injury cases as ... cases along with dog bite related accident cases and others. ... Hastings and Hastings has stood the test of time when ...
(Date:9/19/2014)... According to a report from HarrisMartin ... Xarelto, named as defendants in several lawsuits filed in ... the court to dismiss those suits because the alleged ... with Philadelphia.* The cases include, for instance, Fontan v. ... Comm. Pls., Philadelphia Cty.), which was brought by a ...
(Date:9/19/2014)... 2014 (HealthDay News) -- Your brain structure could help predict ... study suggests. Researchers at Yale University found those with ... the parietal cortex may be more likely to engage in ... , , The study, funded by the U.S. National Institute ... women living in the Northeast. The researchers sought to determine ...
Breaking Medicine News(10 mins):Health News:Nasal Drip Eliminator Invented by InventHelp Client (LCC-218) 2Health News: Cyberbullying Seems to Ramp Up in Middle School 2Health News:Hastings And Hastings Announces a Record Number of Visitors to Its New Phoenix Personal Injury Website 2Health News:Xarelto Makers Seek Dismissal of Cases Brought in Philadelphia, Notes Rottenstein Law Group LLP 2Health News:Xarelto Makers Seek Dismissal of Cases Brought in Philadelphia, Notes Rottenstein Law Group LLP 3Health News:Brain Structure Might Help Predict Risky Behavior 2
... Indiana University study found that young, female breast cancer ... and are interested in using sexual enhancement products to ... Cancer Survivors: Their sexual function and interest in sexual ... the journal Cancer Nursing . , The study ...
... reduced chances by 26% , , SUNDAY, Nov. 9 (HealthDay News) ... an extra benefit: a reduction in their risk of developing ... under the age of 52, according to research that was ... in New Orleans. , The findings, the first to demonstrate ...
... to protect healthy men, either , , SUNDAY, Nov. 9 ... doubt on the cardiac benefits of either low-dose aspirin ... low-dose aspirin did not reduce the risk of cardiovascular ... Harvard researchers concluded that neither vitamin E nor vitamin ...
... Low-dose aspirin as primary prevention did not appear to ... of coronary, cerebrovascular and peripheral vascular events in patients ... in JAMA . However, aspirin did significantly reduce ... The article is being released early online Sunday, November ...
... informed its readers of serious drug reactions and fatalities, which have ... as Heparin. The drug, from Baxter Healthcare, was found to be ... ... Denver (PRWEB) November 9, 2008 -- LegalView.com, the number one legal ...
... they have risk factors that could lead to coronary ... -- Despite certain risk factors, Hispanic patients were 57 ... bypass surgery (CABG) one year after successful angioplasty to ... It also found that Hispanics were less likely to ...
Cached Medicine News:Health News:Sexual intimacy and breast cancer survivors: New research 2Health News:Flu Shots Lower Risk of Blood Clots 2Health News:Flu Shots Lower Risk of Blood Clots 3Health News:Aspirin Doesn't Guard Diabetics Against Heart Disease 2Health News:Aspirin Doesn't Guard Diabetics Against Heart Disease 3Health News:Aspirin Doesn't Guard Diabetics Against Heart Disease 4Health News:Low-dose aspirin does not appear to reduce risk of CV events in patients with diabetes 2Health News:Low-dose aspirin does not appear to reduce risk of CV events in patients with diabetes 3Health News:Low-dose aspirin does not appear to reduce risk of CV events in patients with diabetes 4Health News:LegalView Reports Record Numbers of Drug Reactions in U.S., Partially Caused by Heparin 2Health News:LegalView Reports Record Numbers of Drug Reactions in U.S., Partially Caused by Heparin 3Health News:LegalView Reports Record Numbers of Drug Reactions in U.S., Partially Caused by Heparin 4Health News:Hispanics Less Likely to Get Repeat Artery Surgery 2
(Date:9/19/2014)...  PCI is pleased to announce it has ... leading provider of Clinical Trial Services and Temperature ... Wales in the United ... presence in the UK/EU to support global investigational ... and distribution capacity, as well as consultative services ...
(Date:9/18/2014)... , Sept. 18, 2014  Low T Center ... meeting in Hyattsville, Maryland ... assess the proper patient population for testosterone therapy ... risk associated with TRT. Examining recent claims from studies ... that "available epidemiological studies do not provide convincing ...
(Date:9/18/2014)... , September 18, 2014 ... http://www.researchandmarkets.com/research/f9nkkh/sugar_alcohols ) has announced the addition of ... Report"  report to their offering.  ... the worldwide markets for Sugar Alcohols in ... Food & Confectionery, Pharmaceuticals, Cosmetics, Oral-Care Products, ...
Breaking Medicine Technology:PCI Announces Acquisition Of Biotec 2PCI Announces Acquisition Of Biotec 3PCI Announces Acquisition Of Biotec 4PCI Announces Acquisition Of Biotec 5PCI Announces Acquisition Of Biotec 6Low T Center Endorses The Joint FDA Committee Meeting on Testosterone 2Sugar Alcohols - Global Strategic Business Report 201 2Sugar Alcohols - Global Strategic Business Report 201 3
Singe-pull lace design provides easy-on application to provide support and immobilization of the wrist while preserving finger mobility...
ManuTrain is an active wrist support that has optional features for increased stabilization....
... Bird and Cronin, Inc. ... of Patient Footwear, Orthopedic ... Care Products. Our products ... quality and available in ...
... 3-Point® Polycentric Hinged Ulnar Deviation Splint uses ... the hand with ulnar deviation at the ... grasp or pinch. Radial and ulnar polycentric ... unimpeded flexion and extension. Padded, malleable finger ...
Medicine Products: