Navigation Links
Vion Pharmaceuticals Announces FDA Conclusion
Date:12/30/2009

NEW HAVEN, Conn., Dec. 30 /PRNewswire-FirstCall/ -- VION PHARMACEUTICALS, INC. (OTC Bulletin Board: VION), announced today that the U.S. Food and Drug Administration ("FDA") had responded to its Special Protocol Assessment ("SPA") request to evaluate the Phase III randomized trial HOVON AML 92 sponsored by the Dutch-Belgian Cooperative Group for Hematology Oncology ("HOVON") of its lead product Onrigin(TM). The FDA raised concerns with the HOVON trial design as submitted regarding the primary endpoint and study regimen. The modifications requested by the FDA would require a new Phase III trial at significant additional time and expense.

Vion will evaluate whether to file another SPA for an alternative randomized Phase III trial within the next two weeks. In this context, the SPA process is intended to evaluate a Phase III protocol whose data will form the primary basis for an efficacy claim. The Phase III randomized trial in acute myeloid leukemia ("AML") is in response to the FDA's complete response letter to Vion's New Drug Application for Onrigin(TM) requiring that a randomized trial be conducted to support the approval of Onrigin(TM) for the treatment of AML.

On December 17, 2009, Vion filed a voluntary petition for relief under Chapter 11 of the United States Bankruptcy Code in the United States Bankruptcy Court in the District of Delaware. Vion has retained the services of Roth Capital Partners, LLC to assist with the sale of the Company and/or its key assets during the Chapter 11 proceeding. Additional information about Vion's Chapter 11 case is available on the website of the court's claims agent at www.delclaims.com.

For additional information on Vion and its product development pr
'/>"/>

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

Page: 1 2 3

Related medicine technology :

1. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
2. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
3. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
4. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
5. WallSt.net (www.wallst.net) Updates the Investment Community Through an All-New Interview With RegeneRx Biopharmaceuticals CEO
6. Quark Pharmaceuticals, Inc. Presented Positive Preclinical Results of Systemic RNAi Compound for Acute Renal Failure (ARF)
7. Peregrine Pharmaceuticals Doses First Patient in Cotara(R) Phase II Brain Cancer Trial In India
8. Nabi Biopharmaceuticals Announces Second Quarter 2007 Financial Results
9. Access Pharmaceuticals Provides Update on Clinical Development Plan of ProLindac
10. Quark Pharmaceuticals Extends Research Agreement with State University of New York for Proprietary siRNA Compounds for Acute Hearing Loss
11. Acura Pharmaceuticals, Inc. Secures Financing to Fund Pivotal Phase III Clinical Trial for Lead Aversion(R) Technology Product Candidate
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/30/2015)... July 30, 2015  Lannett Company, Inc. (NYSE: ... at the Canaccord Genuity 35th Annual Growth Conference on ... the InterContinental Boston Hotel.  A webcast ... .  Listeners are encouraged to visit the web site ... the presentation to register, download and install any necessary ...
(Date:7/30/2015)... , July 30, 2015  Alimera Sciences, Inc. ... specializes in the research, development and commercialization of prescription ... second quarter fiscal year 2015 financial results after the ... conference call will follow on the same day at ... , President and Chief Executive Officer, and Rick ...
(Date:7/30/2015)... , Net Sales of $1.17 billion represent ... and an increase of 5.7% constant currency , Reported ... and adjusted earnings per share were $1.59, an increase of ... guidance Zimmer Biomet Holdings, Inc. (NYSE and ... June 30, 2015.  The Company reported second quarter net sales ...
Breaking Medicine Technology:Alimera Sciences To Release Second Quarter Fiscal Year 2015 Financial Results 2Zimmer Biomet Holdings, Inc. Reports Second Quarter 2015 Financial Results 2Zimmer Biomet Holdings, Inc. Reports Second Quarter 2015 Financial Results 3Zimmer Biomet Holdings, Inc. Reports Second Quarter 2015 Financial Results 4Zimmer Biomet Holdings, Inc. Reports Second Quarter 2015 Financial Results 5Zimmer Biomet Holdings, Inc. Reports Second Quarter 2015 Financial Results 6Zimmer Biomet Holdings, Inc. Reports Second Quarter 2015 Financial Results 7Zimmer Biomet Holdings, Inc. Reports Second Quarter 2015 Financial Results 8Zimmer Biomet Holdings, Inc. Reports Second Quarter 2015 Financial Results 9Zimmer Biomet Holdings, Inc. Reports Second Quarter 2015 Financial Results 10Zimmer Biomet Holdings, Inc. Reports Second Quarter 2015 Financial Results 11Zimmer Biomet Holdings, Inc. Reports Second Quarter 2015 Financial Results 12Zimmer Biomet Holdings, Inc. Reports Second Quarter 2015 Financial Results 13Zimmer Biomet Holdings, Inc. Reports Second Quarter 2015 Financial Results 14Zimmer Biomet Holdings, Inc. Reports Second Quarter 2015 Financial Results 15Zimmer Biomet Holdings, Inc. Reports Second Quarter 2015 Financial Results 16Zimmer Biomet Holdings, Inc. Reports Second Quarter 2015 Financial Results 17Zimmer Biomet Holdings, Inc. Reports Second Quarter 2015 Financial Results 18Zimmer Biomet Holdings, Inc. Reports Second Quarter 2015 Financial Results 19Zimmer Biomet Holdings, Inc. Reports Second Quarter 2015 Financial Results 20Zimmer Biomet Holdings, Inc. Reports Second Quarter 2015 Financial Results 21Zimmer Biomet Holdings, Inc. Reports Second Quarter 2015 Financial Results 22Zimmer Biomet Holdings, Inc. Reports Second Quarter 2015 Financial Results 23Zimmer Biomet Holdings, Inc. Reports Second Quarter 2015 Financial Results 24Zimmer Biomet Holdings, Inc. Reports Second Quarter 2015 Financial Results 25Zimmer Biomet Holdings, Inc. Reports Second Quarter 2015 Financial Results 26Zimmer Biomet Holdings, Inc. Reports Second Quarter 2015 Financial Results 27Zimmer Biomet Holdings, Inc. Reports Second Quarter 2015 Financial Results 28Zimmer Biomet Holdings, Inc. Reports Second Quarter 2015 Financial Results 29
(Date:7/30/2015)... , ... July 30, 2015 , ... ... and fourth annual Institute Scholar Program. In partnership with Patient Experience Institute, these ... experience, develop leaders on the front lines and throughout the experience movement, and ...
(Date:7/30/2015)... , ... July 30, 2015 , ... ... the ‘Mary Jo Lawyer-Spano Mesothelioma Patient Registry Act of 2015’. The bill ... Chris Collins (R-NY), Peter King (R-NY), Betty McCollum (D-MN), Joe Kennedy (D-MA), and ...
(Date:7/30/2015)... ... 30, 2015 , ... Boston Web Marketing is ... Google Partners is the platform for search marketing agencies to communicate with the ... necessary to run successful search marketing campaigns. Google Partners also affords businesses the ...
(Date:7/30/2015)... ... July 30, 2015 , ... Ocean Hills Recovery has officially been accredited ... “no recommendations.” No recommendations means CARF found no areas in the OHR program that ... than 3% of all facilities receive. In addition, Ocean Hills was granted the maximum ...
(Date:7/30/2015)... NY (PRWEB) , ... July 30, 2015 , ... ... at Mount Sinai Earns National Cancer Institute Designation , The Tisch Cancer Institute ... a National Cancer Institute (NCI)-designated cancer center. TCI joins an elite group of ...
Breaking Medicine News(10 mins):Health News:The Beryl Institute Opens Applications for 2015 Patient Experience Grant and Scholar Programs 2Health News:The Beryl Institute Opens Applications for 2015 Patient Experience Grant and Scholar Programs 3Health News:Bill to Create Patient Registry for Deadly Cancer Introduced in Congress 2Health News:Boston Web Marketing Attends Google Partners All-Stars Summit 2Health News:Ocean Hills Recovery Receives Accreditation from CARF International 2Health News:The Tisch Cancer Institute at Icahn School of Medicine at Mount Sinai Earns National Cancer Institute Designation 2Health News:The Tisch Cancer Institute at Icahn School of Medicine at Mount Sinai Earns National Cancer Institute Designation 3Health News:The Tisch Cancer Institute at Icahn School of Medicine at Mount Sinai Earns National Cancer Institute Designation 4Health News:The Tisch Cancer Institute at Icahn School of Medicine at Mount Sinai Earns National Cancer Institute Designation 5Health News:The Tisch Cancer Institute at Icahn School of Medicine at Mount Sinai Earns National Cancer Institute Designation 6
... Carell, Stephen, Colbert, Susie Essman, Will Ferrell, Tina Fey, Jonah Hill, Kevin ... Triumph The Insult Comic Dog And Many More To Be ... And xBox Live, Marketplace For $1.99 For 30 Days After Airdate With All ... ...
... Dollar Body(TM) Is Awarding Over One Million Dollars to Help People ... Lose Weight and Get in ... just announced a $50,000 Grand Prize winner in,its Million Dollar Body ... year to spur people to lose weight and get,in shape., ...
... Over One Million Dollars to Help People ... Lose Weight and Get in Better Shape, ANAHEIM, ... Grand Prize winner in,its Million Dollar Body Game(TM), an ongoing incentive ... to lose weight and get,in shape., Phyllis Stewart of Knoxville, ...
... DIEGO, March 10 AMN Healthcare Services,Inc. (NYSE: ... to make a presentation on Tuesday, March 18, 2008 ... Annual Global Healthcare,Conference taking place at the Loews Miami ... and Chief Executive Officer of AMN,Healthcare, will provide an ...
... screen less useful, but some experts disagree , , MONDAY, ... have undermined the value of the prostate-specific antigen (PSA) ... new study asserts. , However, that assertion was immediately ... American Cancer Society recommends annual screening for prostate cancer ...
... to over $1.4 billion by 2012, according to ... Millennium Research Group, ... Markets for Dental Imaging 2008 report, the benefits,associated with dental imaging ... fuel sales in the overall market.,Robust sales will translate into market ...
Cached Medicine News:Health News:COMEDY CENTRAL(R) Announces Live On-Air Charity Special 'Night Of Too Many Stars: An Overbooked Benefit For Autism Education' Hosted by Jon Stewart on Sunday April 13, at 8 p.m. ET 2Health News:COMEDY CENTRAL(R) Announces Live On-Air Charity Special 'Night Of Too Many Stars: An Overbooked Benefit For Autism Education' Hosted by Jon Stewart on Sunday April 13, at 8 p.m. ET 3Health News:Longview, WA Man Wins $50,000 for Losing 82 Pounds 2Health News:Longview, WA Man Wins $50,000 for Losing 82 Pounds 3Health News:Knoxville, TN Woman Wins $50,000 for Losing 77 Pounds 2Health News:Knoxville, TN Woman Wins $50,000 for Losing 77 Pounds 3Health News:AMN Healthcare Services to Present at the Lehman Brothers 11th Annual Global Healthcare Conference 2Health News:PSA Test Losing Diagnostic Value, Study Says 2Health News:PSA Test Losing Diagnostic Value, Study Says 3Health News:Advanced Technology in Dental Imaging Benefits Patients 2Health News:Advanced Technology in Dental Imaging Benefits Patients 3
... PDC Smart™ Labels have a direct ... Texas Instruments Tag-it™ HF-I transponder. When ... codes, text and other graphics may ... variable data is programmed to the ...
... pending solution using Radio Frequency Identification ... label to promote patient safety by ... surgery. This simple to use system ... with the operating room staff in ...
... facilities, recreational venues and more can ... automated data capture that boosts efficiency ... dangerous errors. RFID wristbands can also ... entertainment venues as well as be ...
... The optional Kisses component ... designed to assist nursing staff ... mothers while in the hospital. ... you have an easy, effective ...
Medicine Products: