Navigation Links
Vion Pharmaceuticals Announces Results of the Oncologic Drugs Advisory Committee Meeting for Onrigin(TM)
Date:9/2/2009

NEW HAVEN, Conn., Sept. 2 /PRNewswire-FirstCall/ -- VION PHARMACEUTICALS, INC. (OTC Bulletin Board: VION) today announced the results of the Oncologic Drugs Advisory Committee (ODAC) Meeting at which data for its lead oncology therapeutic Onrigin(TM)(laromustine) Injection were presented for the indication of remission induction treatment for patients sixty years of age or older with de novo poor-risk acute myeloid leukemia (AML).

The ODAC was asked by the U.S. Food and Drug Administration (FDA) to vote on the question of whether a randomized study defining the efficacy and safety of Onrigin in the population proposed for the indication be completed prior to regulatory approval of Onrigin. The ODAC voted 13-0 in favor of completion of a randomized study prior to approval. 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 FDA.

Alan Kessman, Chief Executive Officer, commented, "We are disappointed that the Oncologic Drugs Advisory Committee voted for completion of a randomized trial for Onrigin in the elderly poor-risk AML population prior to approval. We plan to enter into discussions with the FDA about their requirements for a randomized trial and evaluate our options as soon as possible. We would need to raise additional capital to finance a new randomized trial."

The Company reported $26.1 million in cash and cash equivalents at the end of the second quarter of 2009. The Company's current operating plan does not include funding for an additional randomized trial and there can be no assurance that additional capital can be raised.

About Vion Pharmaceuticals

Vion Pharmaceuticals, Inc. is committed to extending the lives and improving the quality of life of cancer patients wo
'/>"/>

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

0

GOOD

Page: 1 2 3

Related medicine technology :

1. Sagent Pharmaceuticals Announces Launch of Adenosine Injection, USP, in 6 mg per 2 mL Single-Dose Vials
2. ISTA Pharmaceuticals Announces Positive Preliminary Phase 3 Clinical Results to Support sNDA Filing for Once-Daily Xibrom(TM) 0.09%
3. NovaBay Pharmaceuticals to Present New Data on Lead Anti-Infective Compound at the 2009 ICAAC Annual Meeting
4. Impax Pharmaceuticals Selects OmniComm Systems to Provide eClinical Solutions for International Phase III Study in Parkinsons Disease
5. Amira Pharmaceuticals Submits IND for Second DP2 Antagonist, AM461
6. Adamas Pharmaceuticals Signs CRADA With U.S. Navy to Conduct Preclinical Studies of Triple-Combination Antiviral Drug Therapy for Influenza A, Including the Novel H1N1 Pandemic Strain
7. Eiger BioPharmaceuticals Announces Initiation of CLEAN-1 HCV Phase 1b Trial
8. Access Pharmaceuticals Provides Update on ProLindac Clinical Development Program
9. Poniard Pharmaceuticals Announces Positive Cardiac Safety Data From Picoplatin Phase 1 Trial Supporting NDA Filing
10. Idenix Pharmaceuticals Successfully Completes Proof-of-Concept Study of IDX184 for the Treatment of Hepatitis C Virus (HCV)
11. Cardax Pharmaceuticals Nominates Clinical Candidate Heptax for Liver Disease; Heptax Ameliorates Inflammation and Oxidative Stress Related to Liver Disease and Metabolic Syndrome
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/23/2013)... DIEGO y PARÍS, 24 de mayo ... VOLC ), un destacado desarrollador y fabricante de ... mejorar la diagnosis y tratamiento de la enfermedad ... preliminares del ensayo ADVISE ( Ad enosine ... E valuation) II durante la sesión de ...
(Date:5/23/2013)... 2013 Neurocrine Biosciences, Inc. (Nasdaq: NBIX ... President and Chief Executive Officer of Neurocrine Biosciences, will be ... Health Care Conference in Boston.   The live ... Eastern Time / 8:20 a.m. Pacific Time.  The presentation will ... at http://www.neurocrine.com . If you are ...
(Date:5/23/2013)... THOUSAND OAKS, Calif. , May 23, 2013 ... Deutsche Bank 38 th Annual  Healthcare Conference on Thursday, ... Boston , beginning at 9:20 a.m. Eastern Daylight ... Investor Relations at Amgen, will present at the conference. Live ... Calendar on Amgen,s website, www.amgen.com , under Investors. A ...
Breaking Medicine Technology:Volcano anuncia los resultados preliminares del estudio ADVISE II y su inclusión en el ensayo SYNTAX2 2Volcano anuncia los resultados preliminares del estudio ADVISE II y su inclusión en el ensayo SYNTAX2 3Volcano anuncia los resultados preliminares del estudio ADVISE II y su inclusión en el ensayo SYNTAX2 4Volcano anuncia los resultados preliminares del estudio ADVISE II y su inclusión en el ensayo SYNTAX2 5Volcano anuncia los resultados preliminares del estudio ADVISE II y su inclusión en el ensayo SYNTAX2 6
... Mass. and TOKYO, Nov. 10 Ironwood Pharmaceuticals, ... they have entered into an agreement providing Astellas ... compound linaclotide in Japan, Indonesia, Korea, the Philippines, ... 3 clinical development in the United States for ...
... Inc. today announced that it has enrolled the 100th patient ... stenosis. "We are well ahead of our projections for 2009," ... the market need, the clinical outcomes that surgeons are seeing, ... Over 1.5 million people are diagnosed with lumbar spinal stenosis ...
Cached Medicine Technology:Ironwood and Astellas Announce Japan Licensing Agreement for Linaclotide 2Ironwood and Astellas Announce Japan Licensing Agreement for Linaclotide 3Facet Solutions Enrolls 100th Patient in US Pivotal IDE Study 2
(Date:5/23/2013)... Mayo Clinic researchers have used next generation genomic analysis ... cancer tumors have similar genetic origins, which may help ... in the journal Cancer Research . , "This ... next generation sequencing in adjacent Gleason patterns in the ... in pathology," says ,John Cheville, M.D., Mayo Clinic pathologist ...
(Date:5/23/2013)... Transvaginal mesh lawsuit claims ... move forward in a federal multidistrict litigation underway in ... Liebhard LLP reports. In an Order issued on ... Bard to seal emails that included supplier information the ... proprietary information about its suppliers. The emails were filed ...
(Date:5/23/2013)... 2013 The vast majority of Americans ... control over their level of physical activity, the healthfulness ... are actually taking that control. Those are among ... Foundation’s 2013 Food & Health Survey. , According to ... to have “a great deal of control” or “complete ...
(Date:5/23/2013)... On April 29th, 2013, UV Technologies ... of H7N9 cases and deaths. The headline read, " UV ... Subside in Northern Hemisphere as Available Daylight Increases .” In ... reported. , Quoting Kevin McGuire, president of UV Technologies, ... budding in the spring and leaves changing in the fall. ...
(Date:5/23/2013)... Cheap Concert Tickets announces that Paul ... at stadiums throughout North America. This well known ticket ... concert tickets to help McCartney fans see Sir Paul live ... states that she is also offering the customer appreciation code ... a baby boomer, she is also a huge McCartney fan ...
Breaking Medicine News(10 mins):Health News:Mayo Clinic genomic analysis lends insight to prostate cancer 2Health News:Transvaginal Mesh Lawsuits Move Forward, as Bernstein Liebhard LLP Notes New Order in Federal C.R. Bard Mesh Implant Lawsuits 2Health News:Transvaginal Mesh Lawsuits Move Forward, as Bernstein Liebhard LLP Notes New Order in Federal C.R. Bard Mesh Implant Lawsuits 3Health News:Americans Experience “Control Gap” Regarding Their Weight, Diet, Activity Level; Rate Their Overall Diet a “B-Minus” 2Health News:Americans Experience “Control Gap” Regarding Their Weight, Diet, Activity Level; Rate Their Overall Diet a “B-Minus” 3Health News:Americans Experience “Control Gap” Regarding Their Weight, Diet, Activity Level; Rate Their Overall Diet a “B-Minus” 4Health News:UV Technologies Bold Prediction on H7N9 in China Comes True, New Cases End Without Aid of Flu Vaccine 2Health News:UV Technologies Bold Prediction on H7N9 in China Comes True, New Cases End Without Aid of Flu Vaccine 3Health News:Paul McCartney Tickets: Prices Slashed on Paul McCartney Tickets in Austin, Brooklyn, Tulsa, Memphis Washington DC, Milwaukee, Boston, Indianapolis, Regina and Seattle 2
... Journal of Clinical Dentistry Demonstrate, Significant Cavity-Fighting ... N.Y. and STONY BROOK, N.Y., April 8, 2008 ... announced today that,new data published in the most ... the effects of a new chewable mint in ...
... Three-year demonstration project will test effectiveness of ... of chronic illness in the,Medicare population, ... Board: HFIT) announced today it is working ... of Pfizer Inc., as part of a,three-year ...
... Huckabee Share Behavior Change Successes ... and Discuss Healthcare Strategies and Trends, PALM SPRINGS, ... in scalable behavior change interventions with outcomes,kicked off ENGAGE ... 250 industry experts and leading employers and health plans,throughout ...
... be the greatest advance in waking up since coffee, ... wake up,in the morning feeling refreshed and ready to go, ... performance to spousal,relations and even driving ability. Fortunately, a unique ... a pill you take before,bedtime that will help you to ...
... 2008 Take a look in your,medicine cabinet ... so, are,you contributing to the nation,s dramatic increase ... National Drug Control,Strategies Report, 71 percent of prescription ... friends. Among 12- to 13-year-olds,prescription drug abuse actually ...
... The appearance of a cold sore is,a sign ... more serious,illnesses emerge, according to John Sherman, ND, noted ... Worldwide, between 80% and 90% of the adult population ... according to Dr. Sherman, who,is the author of The ...
Cached Medicine News:Health News:Cavities in Children Reduced Over 60 Percent by New Experimental Chewable Mints 2Health News:Cavities in Children Reduced Over 60 Percent by New Experimental Chewable Mints 3Health News:Cavities in Children Reduced Over 60 Percent by New Experimental Chewable Mints 4Health News:HealthFitness Teams with Pfizer Health Solutions to Implement CMS Senior Risk Reduction Demonstration Project 2Health News:HealthFitness Teams with Pfizer Health Solutions to Implement CMS Senior Risk Reduction Demonstration Project 3Health News:HealthFitness Teams with Pfizer Health Solutions to Implement CMS Senior Risk Reduction Demonstration Project 4Health News:HealthMedia Kicks Off ENGAGE Conference 2Health News:HealthMedia Kicks Off ENGAGE Conference 3Health News:Tired Mother Invents Pill to Wake You Up On Time 2Health News:Prescription Drug Abuse Threatens Availability of Pain Medication 2Health News:A Cold Sore Is Often A Warning Sign of Deeper Health Issues, Expert Says 2