Navigation Links
Vion Pharmaceuticals Receives a Standard Review from the FDA for Its New Drug Application for Onrigin(TM)
Date:4/23/2009

NEW HAVEN, Conn., April 23 /PRNewswire-FirstCall/ -- VION PHARMACEUTICALS, INC. (OTC Bulletin Board: VION) today announced that the New Drug Application (NDA) for its lead oncology therapeutic Onrigin(TM) (laromustine) Injection has received a standard review classification by the U.S. Food and Drug Administration (FDA). Therefore, a user fee goal date of December 12, 2009 for a decision by the FDA with respect to the approval of the Company's NDA has been established.

The Company had previously announced the acceptance of the NDA filing for review by the FDA on April 16, 2009. The NDA presents data for Onrigin(TM) 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, "Our level of excitement continues to grow as we move forward in the FDA's process of reviewing our NDA. We will continue to work closely with the FDA on the filing with the objective of achieving approval for Onrigin(TM) in its first indication in the United States." He added, "The positive news today is that we can expect to have an FDA decision this year."

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(TM)(laromustine) Injection and Triapine(R). The FDA is reviewing a New Drug Application for Onrigin(TM) 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 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's potential inability to obtain regulatory approval for its products, particularly Onrigin(TM) (laromustine) Injection (formerly Cloretazine (VNP40101M)), delays in the regulatory approval process, particularly for Onrigin(TM) (laromustine) Injection, including possible delays in the FDA's review process beyond our expectation for approval in December 2009, delays or unfavorable results of drug trials, the possibility that favorable results of earlier preclinical studies, clinical trials or interim clinical trial data are not confirmed by safety and efficacy results in later or final clinical trials, the need for additional research and testing, 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 "Risk Factors" in Vion's Post-Effective Amendments on Form S-1 Registration Statement filed on March 23, 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.

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


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

Related medicine news :

1. Valeant Pharmaceuticals to Announce 2009 First Quarter Results on May 5, 2009
2. Genesis Pharmaceuticals Changes its Name to Jiangbo Pharmaceuticals, Inc. to Reflect its Brand Name
3. Lotus Pharmaceuticals, Inc. Reports Strong 2008 Financial Results
4. Genesis Pharmaceuticals Announces the Launch of Three TCM Products
5. Celator(R) Pharmaceuticals Presents New Data on CPX-351 And CPX-1 at the American Association for Cancer Research
6. Poniard Pharmaceuticals Presents Final Results of Phase 1 Study of Oral Picoplatin Demonstrating Bioavailability
7. Par Pharmaceutical Enters Into Agreement With Reliant Pharmaceuticals to Settle Patent Litigation Over Rythmol(R) SR
8. AUDIO from Medialink and Forest Pharmaceuticals: FDA Approves Lexapro for Major Depressive Disorder in Adolescents
9. Strativa Pharmaceuticals Provides Product Pipeline Update
10. ISTA Pharmaceuticals Announces Conference Call and Webcast of First Quarter 2009 Financial Results
11. Amylin Pharmaceuticals Reports First Quarter Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/26/2017)... ... May 26, 2017 , ... Water damage to the flooring of several ... had left education officials with a number of critical issues to address before students ... to be accomplished with little or no disruption to class schedules. Second, the project ...
(Date:5/24/2017)... ... May 24, 2017 , ... In modern research, success depends ... instruments for research and understanding the basic principles that were designed to drive ... innovations in stereo microscopy for brightfield and fluorescence typically used in laboratories working ...
(Date:5/24/2017)... ... 24, 2017 , ... Altec Products, Inc., a leader in enterprise ... one-day technology conference in San Diego, CA. , At nVerge 2017, Altec will ... utilize and enhance their Sage ERP solutions by providing improved visibility and control to ...
(Date:5/24/2017)... ... May 24, 2017 , ... Drs. ... NY, who have now spent 10 years as clinical instructors for the reputable ... College of Dentistry. Through the program, private practitioners receive cutting-edge clinical training and ...
(Date:5/24/2017)... ... , ... Patients who want to receive cosmetic dentistry procedures such as Invisalign® ... for a consultation, with or without a referral. Dr. Bedich enjoys improving the appearance ... , Dr. Bedich offers a variety of cosmetic dentistry services at his practice that ...
Breaking Medicine News(10 mins):
(Date:5/10/2017)... MARLBOROUGH, Mass., May 10, 2017 Hologic, Inc. ... financial results for the fiscal second quarter ended April ... (EPS) of $1.84 increased 666.7% compared to the prior ... business resulted in a significant gain, while non-GAAP diluted ... increased 3.2%, or 3.8% in constant currency terms.  Excluding ...
(Date:5/10/2017)... Md. , May 10, 2017 CSSi, ... solutions for the clinical research industry, is proud to ... www.CSSiEnroll.com . The new website features both enriched content ... user experience and enhances the company,s already well-established position ... industry. "After many months of hard ...
(Date:5/9/2017)... 9, 2017  Semler Scientific, Inc. (OTCQB: SMLR), ... to improve the clinical effectiveness and efficiency of ... first quarter ended March 31, 2017. ... customers to identify when preventive care options are ... like heart attacks or strokes occur," said ...
Breaking Medicine Technology: