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 programs, visit the Company's Internet web site at www.vionpharm.com.

This news release contains forward-looking statements. Such statements are subject to certain risk factors which may cause Vion's plans to differ or results to vary from those expected, including Vion being unsuccessful in selling its assets or engaging in another transaction in bankruptcy, the FDA not approving Vion's Special Protocol Assessment for a Phase III randomized trial for Onrigin(TM) , Vion not obtaining court approval of its motions in the Chapter 11 proceeding pursued by it from time to time, Vion's ability to develop, pursue, confirm and consummate one or more plans of reorganization with respect to the Chapter 11 case, Vion's ability to retain and compensate key executives and other key employees, Vion's ability to maintain relationships with its licensor and vendors, Vion's potential inability to obtain regulatory approval for its products, particularly Onrigin(TM), delays in the regulatory approval process, particularly for Onrigin(TM), delays or unfavorable results of drug trials, the need for additional research and testing, including the need for a randomized trial of Onrigin(TM) prior to regulatory approval, the inability to manufacture product, the potential inability to secure external sources of funding to continue operations, the inability to access capital and funding on favorable terms, continued operating losses and the inability to continue operations as a result, and a variety of other risks set forth from time to time in Vion's filings with the Securities and Exchange Commission, including but not limited to the risks attendant to the forward-looking statements included under Item 1A, "Risk Factors" in Vion's Form 10-K for the year ended December 31, 2008 and Vion's Form 10-Q for the quarter ended September 30, 2009. Except in special circumstances in which a duty to update arises under law when prior disclosure becomes materially misleading in light of subsequent events, Vion does not intend to update any of these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.


    Vion Pharmaceuticals, Inc.
    Alan Kessman, Chief Executive Officer
    Howard B. Johnson, President & CFO
    (203) 498-4210

SOURCE Vion Pharmaceuticals, Inc.


'/>"/>
SOURCE Vion Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

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:6/7/2017)... -- Endo International plc (NASDAQ: ENDP ) ... Joseph R. Goodwin , U.S. District Court Judge for ... , entered a case management order in MDL 2325, ... Litigation (the "MDL") that includes a provision requiring plaintiffs ... on specific causation within one hundred twenty (120) days ...
(Date:6/7/2017)... Specialty Infusion Group, a brand of Diplomat Pharmacy, Inc. (NYSE: DPLO), ... location. The Iowa ... 7 cleanroom—the standard needed to compound intravenous (IV) nutrition formulations. A ... "Our new cleanroom will allow ... Iowa patients," said Phil Rielly , ...
(Date:6/5/2017)... 2017 Kohll,s Pharmacy & Homecare is the first distributor ... States . The Raizer is a simple battery operated ... to an almost-standing position within a few minutes. ... assistant and does not require any extra effort besides ... child can operate it, and lightweight and portable ...
Breaking Medicine Technology:
(Date:6/26/2017)... Ruidoso, New Mexico (PRWEB) , ... June 26, ... ... sexual dysfunction, anorgasmia, and urinary leakage is revolutionizing the way women look and ... Mexico is tackling the problem of female sexual dysfunction and urinary leakage head ...
(Date:6/26/2017)... ... June 26, 2017 , ... If the devil ... lots of red these days. According to recent estimates, 75 – 80% of ... coding errors(1). Some studies point to Electronic Health Records (EHR) with automated features ...
(Date:6/26/2017)... ... June 26, 2017 , ... New patients with ... Angela Cotey, with or without a referral. Dr. Cotey is a trusted dentist who ... preferred tooth replacement option. , Patients with missing teeth in Fitchburg, WI, are encouraged ...
(Date:6/25/2017)... , ... June 24, 2017 , ... Create a feel-good lyric music video in Final ... and sound in the timeline and write in the lyrics to any song. ProLyric flies ... out. Each line of the text can be added modularly for optimal control. ProLyric makes ...
(Date:6/25/2017)... , ... June 25, 2017 , ... An increase in ... growing foliage and plants, and along with that; a humdinger of an allergy season. ... it also means an increase in misery-causing grass and weed pollen. , “Our ...
Breaking Medicine News(10 mins):