Navigation Links
Vion Pharmaceuticals Announces FDA Lift of Clinical Hold on Phase III Study of Cloretazine(R) (VNP40101M) and Cytarabine in Relapsed AML
Date:1/8/2008

Company to Hold Conference Call at 10:30 A.M. Eastern Time Today

NEW HAVEN, Conn., Jan. 8 /PRNewswire-FirstCall/ -- VION PHARMACEUTICALS, INC. (Nasdaq: VION) today announced that the U.S. Food and Drug Administration (FDA) had lifted the clinical hold on the Phase III trial (Vion Study CLI-037) of its lead anti-cancer agent, Cloretazine(R) (VNP40101M), in combination with cytarabine in relapsed acute myelogenous leukemia (AML).

Alan Kessman, Chief Executive Officer, said, "We are pleased with the FDA's decision to lift the clinical hold on Cloretazine(R) (VNP40101M) in combination with cytarabine in relapsed AML, and are now poised to move forward with the clinical development of Cloretazine(R) (VNP40101M) in the relapsed setting."

While this trial remains blinded overall, a portion of data on 210 patients was unblinded for review at interim analysis. The Company's medical consultants and external independent reviewers performed a comprehensive safety analysis of Vion Study CLI-037. This analysis concluded that the combined myelosuppressive effects of Cloretazine(R) (VNP40101M) and cytarabine given at the dose and schedule at which they were combined in the trial, in conjunction with the poor hematologic reserve of patients with relapsed AML, were major factors in the difference in mortality seen between the two arms of the study. A review of records from patients who died did not suggest any previously unreported toxicity for Cloretazine(R) or cytarabine.

There was an increase in the response rate observed on the Cloretazine(R) (VNP40101M) and cytarabine arm of the trial relative to the cytarabine and placebo arm, despite the difference in deaths between the two arms. Given this observed increase in response
'/>"/>

SOURCE Vion Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

1

GOOD

Page: 1 2 3 4 5

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:5/21/2013)... May 21, 2013 STAAR Surgical Company (NASDAQ: ... marketer of minimally invasive ophthalmic products, today announced that ... review the Company,s recent financial results and business developments ... will present at the 38 th Annual Deutsche ... at the Westin Waterfront Hotel on Wednesday, May ...
(Date:5/20/2013)... --   , Campaign launched ... to address the large physical and economic costs of ... affect 700 million people annually and account for 30 ... ,Do You Mind?, helps patients, family members, policymakers and ... collectively address MNDs , Today the International ...
(Date:5/20/2013)... Landauer, Inc. (NYSE: LDR ), ... and monitoring, outsourced medical physics services and high quality ... Directors declared, at its meeting on May 16, 2013, ... for the third quarter of fiscal 2013.  The dividend ... of record on June 7, 2013. About ...
Breaking Medicine Technology:STAAR Surgical To Present At Upcoming Investor Conferences 2Research-based Pharmaceutical Industry Launches 'Do You Mind?' Campaign to Fight Mental and Neurological Disorders 2Landauer, Inc. Declares Regular Cash Dividend 2
... TULSA, Okla., Sept. 1, 2011 Hillcrest ... SouthCrest Hospital in Tulsa, Okla., and Claremore Regional Hospital ... the agreement were not disclosed. The transaction ... Hospital, the 89-bed Claremore Regional Hospital, more than 70 ...
... PAUL, Minn., Sept. 1, 2011 Angeion Corporation (NASDAQ: ... third quarter ended July 31, 2011. Angeion ... the third quarter of fiscal 2010. Angeion incurred a net ... income of $126,000, or $0.03 per diluted share in the ...
Cached Medicine Technology:Hillcrest Completes Purchase of SouthCrest & Claremore Hospitals 2Angeion Corporation Reports Third Quarter Fiscal 2011 Operating Results 2Angeion Corporation Reports Third Quarter Fiscal 2011 Operating Results 3Angeion Corporation Reports Third Quarter Fiscal 2011 Operating Results 4Angeion Corporation Reports Third Quarter Fiscal 2011 Operating Results 5Angeion Corporation Reports Third Quarter Fiscal 2011 Operating Results 6Angeion Corporation Reports Third Quarter Fiscal 2011 Operating Results 7
(Date:5/21/2013)... of sudden infant death syndrome (SIDS) is five times ... study finds. British researchers noted that bed-sharing increases ... drink, use illegal drugs or smoke. They advised that ... infant death in developed countries, would drop dramatically if ... the United States, all parents are advised to not ...
(Date:5/21/2013)... The warning images Brussels proposes to include on tobacco ... the desired impact on smokers because they only find ... Commission wants to improve the efficacy of its anti-smoking ... that make a stronger emotional impact., These are some ... of Personality, Evaluation and Psychological Treatment at the University ...
(Date:5/21/2013)... known for their health benefits, and the subtropical ... drugs are delivered to specific tumor cells. , ... create nanoparticles using natural lipids derived from grapefruit, ... drug delivery vehicles. UofL scientists Huang-Ge Zhang, D.V.M., ... (May 21, 2013), published their findings in ...
(Date:5/21/2013)... Representatives with Hammerhead Bicycles announced today that their re-launched bike ... achieved its overall goal of becoming a standalone brand. , ... Bicycles from a house brand to a standalone bike brand,” ... that the bike shop will go forward as Switchback ... 29er and 650b. , “The bike shop will ...
(Date:5/21/2013)... 21, 2013 TheBeautyPlace.com helps brides to ... features a Big Day Kit including all the essentials ... to shine on their Wedding Day. , TheBeautyPlace.com features ... about on their Wedding Day. Flowers blooming and warmer ... of wedding season. From Memorial Day to October, brides ...
Breaking Medicine News(10 mins):Health News:Bed-Sharing Raises SIDS Risk Fivefold, Study Finds 2Health News:Warning images for cigarette packs proposed by Europe do not make enough emotional impact 2Health News:UofL scientists uncover how grapefruits provide a secret weapon in medical drug delivery 2Health News:Hammerhead Bicycles Now a Standalone Brand 2Health News:TheBeautyPlace.com Previews their Emergency Big Day Kit to Get Brides Ready For this Upcoming Wedding Season 2Health News:TheBeautyPlace.com Previews their Emergency Big Day Kit to Get Brides Ready For this Upcoming Wedding Season 3
... Itamar Medical ... ... Medicine, Mayo Clinic, Rochester, MN Dr. Peter Friberg, Sahlgrenska University ... Mr. Israel Schreiber, President and CEO, Itamar Medical ...
... reduced heart risks after angioplasty/stenting, but raised bleeding risks ... -- A new anti-clotting drug might one day challenge Plavix, ... procedures to open blocked coronary arteries, a new study suggests. ... -- notably those who had had a prior stroke, were ...
... ORLANDO, FL A North Carolina team of doctors, ... up with a way to provide faster, more effective ... require expensive drugs or fancy new equipment. But it ... on everyone involved to move treatment forward empowering ...
... Calif., Nov. 4 Consistent implementation of,proven ... to a Kaiser,Permanente (KP) abstract, published this ... in Orlando, Florida. The researchers followed ... to Kaiser Permanente emergency departments in Northern,California ...
... research suggests , , SUNDAY, Nov. 4 (HealthDay News) ... typically need open-heart surgery might someday have a new, ... , The balloon is inserted percutaneously (through the skin), ... said. In a new study, the procedure -- not ...
... risk of major cardiovascular events by 19, percent, significantly ... ... bleeding, TOKYO and INDIANAPOLIS, Nov. 4 ... investigational,antiplatelet agent prasugrel produced a highly significant 19 percent,reduction in relative ...
Cached Medicine News:Health News:How Early Can We Detect Cardiovascular Disease Less Expensively ... Even in Childhood? 2Health News:New Anti-Clotting Drug Shows Promise in Heart Patients 2Health News:New Anti-Clotting Drug Shows Promise in Heart Patients 3Health News:RACE: a statewide model of better, faster heart attack care 2Health News:RACE: a statewide model of better, faster heart attack care 3Health News:Following Heart Disease Guidelines Saves Lives, According to a Kaiser Permanente Abstract Presented at AHA Scientific Sessions 2Health News:Following Heart Disease Guidelines Saves Lives, According to a Kaiser Permanente Abstract Presented at AHA Scientific Sessions 3Health News:Balloon Valve May Be Alternative to Open-Heart Surgery 2Health News:Balloon Valve May Be Alternative to Open-Heart Surgery 3Health News:In Landmark Phase III Head-to-Head Study, Prasugrel Statistically Superior to Clopidogrel in Reducing Risk of Heart Attack 2Health News:In Landmark Phase III Head-to-Head Study, Prasugrel Statistically Superior to Clopidogrel in Reducing Risk of Heart Attack 3Health News:In Landmark Phase III Head-to-Head Study, Prasugrel Statistically Superior to Clopidogrel in Reducing Risk of Heart Attack 4Health News:In Landmark Phase III Head-to-Head Study, Prasugrel Statistically Superior to Clopidogrel in Reducing Risk of Heart Attack 5Health News:In Landmark Phase III Head-to-Head Study, Prasugrel Statistically Superior to Clopidogrel in Reducing Risk of Heart Attack 6Health News:In Landmark Phase III Head-to-Head Study, Prasugrel Statistically Superior to Clopidogrel in Reducing Risk of Heart Attack 7
... Series 2000 Pipette is a synonym for ... and robust design, and superior operating comfort. ... operate the measuring stroke and blow-out as ... "pipette/tip" system ensures utmost accuracy and precision. ...
50L...
... precision, ergonomics, and value!, Comfortable ... soft non-slip, contoured handle , Finer ... plunger spring action , Completely autoclavable ... the need for recalibration , Easy-to-read ...
... Reference Series 2000 Pipette is a synonym ... compact and robust design, and superior operating ... to operate the measuring stroke and blow-out ... features:Eppendorf "pipette/tip" system ensures utmost accuracy and ...
Medicine Products: