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

rate, the Company has proposed an amended trial to continue its interest in the relapsed setting.

An agreement has been reached with the FDA on modifications to Vion Study CLI-037. The revised study includes a lower dose of Cloretazine(R) (VNP40101M) in the experimental arm of the trial and prophylactic therapy with antibiotics, antifungals and growth factors for all patients. In order to maintain the Special Protocol Assessment (SPA) with the FDA for this trial, the next step is to submit an SPA to the FDA with these modifications before recommencing the trial.

Dr. Frank Giles, Chief of the Division of Hematology and Medical Oncology at the University of Texas Health Science Center at San Antonio, and lead investigator on the Cloretazine(R) clinical program stated, "Cloretazine(R) has recently shown very significant single agent activity in a the difficult to treat elderly AML patient population. It is important that we now establish the optimal dosing schedule in combination with other chemotherapeutic agents, such as cytarabine." He concluded, "Modifications to this Phase III trial in patients with relapsed AML will allow us to examine a combination schedule that should maintain the activity observed in the initial portion of the study with an acceptable marrow toxicity profile."

The Company also announced plans to file an abstract on data from Vion Study CLI-037 for the Annual Meeting of the American Society of Clinical Oncology (ASCO(R)) in June 2008.

Ann Cahill, Vice President, Clinical Development, commented, "Cloretazine(R) (VNP40101M) is an active agent in AML, and we continue to believe that it will have clinical utility in both the frontline and second line settings, as either a single agent or in combination with other therapies."

The Company has announced previously that it plans to file a New Drug Application with the FDA in 2008 based on a pivotal Phase II study of Cloretazine(R) (VNP40101M) as a single agent in eld
'/>"/>

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

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:5/29/2015)... Actinobac Biomed, NovoPedics, Inc. and MentiNova, Inc., ... Foundation Venture Capital Group (FVCG), have been selected to ... of the Start-Up Stadium and Company Presentation forums offered ... Golubieski . The annual convention, the largest ... in Philadelphia in June. ...
(Date:5/29/2015)... , May 28, 2015 Research and ... of Jain PharmaBiotech,s new report "Cardiovascular Drug ... their offering. Drug delivery to the ... systems because of the anatomy and physiology of ... to all organs of the body. Drugs can ...
(Date:5/29/2015)... and BOSTON , May 29, ... instrument development, custom automation, and contract manufacturing, and ... Nanopatch™ needle-free drug delivery technology, have been named winners ... the Nanopatch Jet Coating Instrument , an advanced ... and product development.  The award was announced last evening ...
Breaking Medicine Technology:Foundation Venture Capital Group Portfolio Companies to be Highlighted at Bio International in June 2Foundation Venture Capital Group Portfolio Companies to be Highlighted at Bio International in June 3Global Cardiovascular Drug Delivery Market 2015 - Technologies, Markets and Companies 2Global Cardiovascular Drug Delivery Market 2015 - Technologies, Markets and Companies 3Invetech And Vaxxas Named Recipients Of The 2015 Good Design Award For Development Of Nanopatch Jet Coating Instrument For Needle-Free Drug Delivery 2Invetech And Vaxxas Named Recipients Of The 2015 Good Design Award For Development Of Nanopatch Jet Coating Instrument For Needle-Free Drug Delivery 3
... (Nasdaq: DRRX ) announced today that management ... (Logo:   http://photos.prnewswire.com/prnh/20020717/DRRXLOGO ) ... Stifel Nicolaus Healthcare Conference in Boston on Thursday, September ... webcast of the presentation will be available by accessing ...
... into blood-related diseases saves and improves the lives of millions ... this fact means that too often, funding does not feed ... "Haematology is probably the area of medicine that has progressed ... "La Sapienza" University of Rome. "For example, acute lymphoblastic leukaemia ...
Cached Medicine Technology:DURECT Corporation to Participate in Upcoming Healthcare Conferences 2Better Funding for Research into Blood Diseases Will Save More Lives 2
(Date:5/29/2015)... PA (PRWEB) May 29, 2015 M3 ... quiz-based learning in 14 medical specialties, now offers ... a wide spectrum of rheumatology disorders ranging from Fibromyalgia ... Saint Jacques, editorial director of MDLinx, and Caroline Tredway, ... about the impact it will have on the physicians ...
(Date:5/29/2015)... The science of Follicular Unit Extraction ... more efficient methods of FUE hair transplantation have increased the ... the most cutting edge hair transplant methods being used to ... of extracting hair from the beard to the scalp. , ... correct male pattern baldness. Beard hair has a life ...
(Date:5/29/2015)... 2015 Jan Wooden Howse lost her husband ... above all else: God does no wrong. , It’s fitting, ... son’s passing is titled “God Does No Wrong.” It focuses ... great personal tragedy. , “My story has a positive ... you into something productive, something healing,” Howse said. , “God ...
(Date:5/29/2015)... 2015 World Patent Marketing, a vertically ... it has signed a 10 year licensing agreement for ... to let people learn about any topic and get ... "This is an exciting day for World Patent Marketing ... Cooper, CEO and Creative Director of World Patent Marketing, ...
(Date:5/29/2015)... NY (PRWEB) May 29, 2015 Mediaplanet ... the “beauty of protection”. Skin Health is a ... Today within the markets of New York, Los Angeles, ... estimated 750,000 readers. Its digital counterpart will reach a ... hubs. To read more the Skin Health campaign and ...
Breaking Medicine News(10 mins):Health News:MDLinx Launches Smartest Rheumatologist 2Health News:Beard to Scalp Hair Transplant: Newest Advance in Hair Transplant Technology 2Health News:Turning grief from a child’s passing into virtue 2Health News:Licensing Alert! World Patent Marketing's Latest Blockbuster Licensing Deal Gets A New Twist on Technology With The Live Expert Chat Room 2Health News:Licensing Alert! World Patent Marketing's Latest Blockbuster Licensing Deal Gets A New Twist on Technology With The Live Expert Chat Room 3Health News:Licensing Alert! World Patent Marketing's Latest Blockbuster Licensing Deal Gets A New Twist on Technology With The Live Expert Chat Room 4Health News:Licensing Alert! World Patent Marketing's Latest Blockbuster Licensing Deal Gets A New Twist on Technology With The Live Expert Chat Room 5Health News:Mediaplanet Launches “Skin Health” Campaign Featuring Colorescience 2
... leads to disease, study finds , WEDNESDAY, April 7 ... way to detect lung cancer in its early or ... reverse the start of the deadly disease with a ... exciting," said Dr. Patrick Nana-Sinkam, a lung cancer expert ...
... they can outstrip their blood supply, leaving them short of ... needs less oxygen but more sugar. Researchers at the ... and Richard J. Solove Research Institute have designed an experimental ... to self destruct. The agent, called OSU-CG12, is an ...
... ... to serve as Executive Vice President and Chief Operating Officer of the company, effective ... services to self insured employers, other benefit sponsors and health service organizations utilizing a ... ...
... have higher death rates than rich within first decade , ... to die within five to 10 years after heart surgery than ... men, 6,932 white women, 678 black men and 564 black women ... and found that the poorest patients were 19 to 26 percent ...
... ... product and material testing, unveiled a new website designed to help medical device manufacturers ... ... http://www.testedandproven.com/-- DDL, leader in medical device package, product and material testing, unveiled ...
... Intermittent exotropia, a condition in which the eyes turn outward ... American children and is less common than esotropia, where the ... 2010 issue of the American Journal of Ophthalmology , ... followed 135 patients with intermittent exotropia over a 20-year period ...
Cached Medicine News:Health News:Simple Test May Spot Early Lung Cancer 2Health News:Simple Test May Spot Early Lung Cancer 3Health News:New agent chokes off energy supply, kills cancer cells 2Health News:HCMS Group LLC Names Mick Simon Chief Operating Officer 2Health News:Poor More Likely to Die Following Heart Surgery 2Health News:DDL Launches a New Website offering Insight for Medical Device Manufacturers 2Health News:DDL Launches a New Website offering Insight for Medical Device Manufacturers 3Health News:90 percent of children with intermittent exotropia will become nearsighted by 20 years of age 2
FlexWear is a cross-linked hydrocolloid skin barrier that provides aggressive adherence and is designed for more than one day weartime....
Protects skin from corrosive drainage with the standard wear, FlexWear skin barrier. Extra Security with porous tape....
Inquire...
... Protects the skin over extended ... Flextend skin barrier is the ... and ileostomies. Security and confidence ... and a drain valve that ...
Medicine Products: