Navigation Links
Vion Pharmaceuticals Announces Oncologic Drugs Advisory Committee Meeting for Onrigin(TM)
Date:8/10/2009

NEW HAVEN, Conn., Aug. 10 /PRNewswire-FirstCall/ -- VION PHARMACEUTICALS, INC. (OTC Bulletin Board: VION) today announced the date and location of the Oncologic Drugs Advisory Committee (ODAC) Meeting at which its lead oncology therapeutic Onrigin(TM) (laromustine) Injection will be presented.

The ODAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer and makes appropriate recommendations to the U.S. Food and Drug Administration (FDA).

The meeting will be held on September 1, 2009 at the Hilton Washington DC/Silver Spring, 8727 Colesville Road, Silver Spring, MD. Background materials for the meeting are expected to be made available by the FDA on its website no later than two business days before the meeting.

Alan Kessman, Chief Executive Officer, commented, "We look forward to our meeting with the Oncologic Drugs Advisory Committee in September. It is one more step towards achievement of our main objective which is approval for Onrigin(TM) in its first indication in the United States in 2009."

The Company announced previously that it had received a standard review classification from the FDA for its New Drug Application (NDA) for Onrigin(TM) and a user fee goal date of December 12, 2009 for a decision by the FDA with respect to approval.

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.

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((R) )(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, Vion's Form 10-Q for the quarter ended March 31, 2009, and 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. Arena Pharmaceuticals to Present at the NewsMakers in the Biotech Industry Conference
2. Schering-Plough/Merck Pharmaceuticals Announce FDA Filing Acceptance of New Drug Application for Loratadine/Montelukast Tablet
3. Provectus Pharmaceuticals, Inc. Begins Phase 2 Clinical Trial for Metastatic Melanoma
4. Idenix Pharmaceuticals to Present at Two Upcoming Investor Conferences
5. Vista Partners Updates Coverage on Tapestry Pharmaceuticals
6. Transcept Pharmaceuticals, Inc. to Present at UBS 2007 Global Life Sciences Conference
7. Crystal Research Associates, LLC Issues Executive Informational Overview(R) (EIO(R)) on Tapestry Pharmaceuticals, Inc.
8. Amylin Pharmaceuticals to Webcast Corporate Overview During 43rd Annual Meeting of the European Association for the Study of Diabetes
9. Major Pharma Clinical Case Studies From Amgen, AstraZeneca, GSK, Intermune, Cephalon Inc, Sunesis Pharmaceuticals and Dartmouth Medical School During Fall Clinical Focused Programs
10. Provectus Pharmaceuticals, Inc. releases summary results of phase 1 metastatic melanoma study
11. Class Settlement Could Result in Considerable Savings for Certain Consumers of Prescription Pharmaceuticals
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/24/2017)... ... ... Dr. Ronald E. Hawkins, vice president for academic affairs ... Bell, DO, MBA, HPF, FACOEP-dist., FACEP, as the new dean of Liberty ... to Liberty from the Ohio University Heritage College of Osteopathic Medicine (OU-HCOM), where ...
(Date:2/24/2017)... ... February 24, 2017 , ... The narrative in “ Signal 8: ... ’s true account of his paramedic experiences. Schanssema describes the tragedies he saw, as ... attempts to overcome them. , Schanssema, initially unsure of the career path he wanted ...
(Date:2/24/2017)... ... , ... Indiana Fiber Network (IFN) President and CEO Kelly C. Dyer recently ... as the Chairman of the Management Committee when IFN was originally formed in 2002 ... of investor/owners and development of the business plan. He became the first paid ...
(Date:2/23/2017)... ... February 23, 2017 , ... Thinksport, the most ... Jensie Gran Fondo of Marin. For the second year in a row, cyclists ... sunscreen. , “We are thrilled to provide our safe, non-toxic sunscreen to over ...
(Date:2/23/2017)... ... February 23, 2017 , ... The American Cleft Palate-Craniofacial Association (ACPA) is pleased ... KLS is a longtime supporter of the event. , "We are pleased that KLS ... Dr. Bob Havlik, 2017 ACPA President. "KLS Martin has a long track record of ...
Breaking Medicine News(10 mins):
(Date:2/24/2017)... Feb. 24, 2017 Zimmer Biomet Holdings, Inc. ... healthcare, will present at the Cowen and Company 37 ... Marriott Copley Place on Tuesday, March 7, 2017 at ... webcast of the presentation can be accessed at ... following the conference via Zimmer Biomet,s Investor Relations website ...
(Date:2/24/2017)... , Feb. 24, 2017  In conjunction with ... 2016 financial results press release, you are invited to ... live over the internet on Tuesday, March 14, 2017 ... A live audio webcast of the presentation ... www.durect.com and clicking "Investor Relations."  If you are ...
(Date:2/24/2017)... 24. Februar 2017 ITL Limited, ( ... Gesundheitsbereiches, ist erfreut, für das zum 31. Dezember ... Vorjahreszeitraum exzellente Ergebnisse vorlegen zu können. Eine vollständige ... Wachstum" finden Sie hier . ... Steuern 2,12 Millionen USD (Dez. 2015: 1,04 Millionen USD; +104 %) ...
Breaking Medicine Technology: