Navigation Links
Independent Monitoring Board Recommends Completion of Accrual to Genasense(R) Phase 3 AGENDA Trial in Advanced Melanoma
Date:9/15/2008

BERKELEY HEIGHTS, N.J., Sept. 15 /PRNewswire-FirstCall/ -- Genta Incorporated (OTC Bulletin Board: GNTA) announced today that the independent Data Monitoring Board (DMB) for AGENDA, a Phase 3 trial of the Company's lead oncology product Genasense(R) (oblimersen sodium) Injection, has completed its review. During its review, the DMB evaluated safety data from the study and conducted an analysis for futility. With more than half of the initially planned number of patients now enrolled, the Board recommended that the trial continue to completion of full enrollment.

AGENDA is a Phase 3, randomized, double-blind, placebo-controlled trial that is intended to support global registration of Genasense for patients with advanced melanoma. The study is designed to confirm certain safety and efficacy results from Genta's prior randomized trial of Genasense combined with dacarbazine (DTIC) in patients identified by a biomarker who have not previously received chemotherapy. The co-primary endpoints of AGENDA are progression-free survival and overall survival. A total of 300 patients are expected to enroll in AGENDA.

Genta will provide a pooled update of blinded data from AGENDA, compared with data obtained in this biomarker-defined population from the Company's previous Phase 3 trial (see below), at an international scientific meeting, Perspectives in Melanoma XII, that is scheduled for October 2-4, 2008.

"We remain quite pleased with the high investigator enthusiasm for AGENDA," said Dr. Loretta M. Itri, M.D., Genta's President, Pharmaceutical Development. "We currently anticipate that accrual will complete in the first quarter of 2009."

About AGENDA

AGENDA employs a biomarker to define those patients who derived maximum clinical benefit during a large randomized study of DTIC with or without Genasense, known as study GM301. These patients are characterized by low-normal levels of LDH (lactate dehydrogenase), a tumor-derived enzyme that
'/>"/>

SOURCE Genta Incorporated
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. Three Studies by Independent Scientists Highlighting Pressure Cycling Technology (PCT) to be Presented this Week at the British Mass Spectrometry Societys 29th Annual Meeting
2. Arena Pharmaceuticals Continues Phase 3 BLOOM Obesity Trial Following Independent Echocardiogaphic Data Safety Monitoring Board Review
3. Arena Pharmaceuticals Continues Phase 3 BLOOM Obesity Trial Following Independent Echocardiographic Data Safety Monitoring Board Review
4. InterCure and Mashco Announce Launch into Independent Pharmacies in the United Kingdom
5. Mindray Announces Appointment of Dr. Jixun Lin as Independent Director
6. Roche to Nominate Independent Directors for Election at Ventanas 2008 Annual Stockholders Meeting
7. Independent Data Safety Monitoring Board Recommends Continuation of Sangarts Pivotal Phase III Trials of Hemospan(R)
8. Kiwa Fertilizers Pass Independent Tests
9. Amarin Appoints Dr. William Mason as Lead Independent Director
10. China Pharma Appoints Three Independent Non-Executive Directors
11. China Technology Appoints Deloitte Touche Tohmatsu CPA as Independent Auditor
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/14/2014)... (PRWEB) January 14, 2014 Carahsoft and ... Thursday, January 23, 2014 at 2pm EST (11am PST), ... The topic focuses on how technology can turn raw, ... decisions for government agencies. The online webinar will last ...
(Date:1/14/2014)... BURLINGAME, Calif. , Jan. 14, 2014 As pet owners ... no doubt many of them wrote: "Take better care of my ... and even designer clothes and top-brand carrying cases to take the ... Pet parents might also feel compelled to buy some pricey toys ...
(Date:1/14/2014)... and BETHESDA, Md. , Jan. 14, ... with two institutes from the National Institutes of Health ... bringing safer, more effective treatments to patients on a ... for Advancing Translational Sciences (NCATS) and the National Eye ...
(Date:1/14/2014)... WESTBOROUGH, Mass. , Jan. 14, 2014  RXi ... on discovering, developing and commercializing innovative therapies addressing ... announced that it received the Notice of Allowance ... on its unique self-delivering RNAi compounds (sd-rxRNA®), for ...
Breaking Biology Technology:Webcast - Natural Language Processing: Converting Raw Data into Actionable Knowledge – Hosted by Carahsoft and CDS Federal Services 2New Year's Resolution: Give Pets the Gift of Top-Notch Health Care 2Organovo Announces Collaboration with National Institutes of Health 2Organovo Announces Collaboration with National Institutes of Health 3RXi Pharmaceuticals Receives US Notice of Allowance for a Key Patent Relating to its Self-Delivering Technology with sd-rxRNAs targeting CTGF, including RXI-109, for the Treatment of Fibrotic Disorders 2RXi Pharmaceuticals Receives US Notice of Allowance for a Key Patent Relating to its Self-Delivering Technology with sd-rxRNAs targeting CTGF, including RXI-109, for the Treatment of Fibrotic Disorders 3
... Computers are getting smaller and smaller. And as hand-held devices ... laptops get more powerful, the race is on to ... information storage on tiny formats. , Researchers at The University ... properties of carbon nanotubes to create a cheap and compact ...
... Nov. 11 In a presentation,today at the ... from Baylor College of Medicine have presented,data from ... measuring the genetic risk factor on chromosome 9p21,detected ... factors to,improve the assessment of individual risk of ...
... part of the,"SCIENCEsuisse" project, swissinfo.ch is presenting profiles ... disciplines. The focus is on,Switzerland,s high international reputation ... SSR idee suisse initiative, in collaboration with,the Swiss ... give readers an insight into what,scientists are studying ...
Cached Biology Technology:Miniaturizing memory: Taking data storage to the molecular level 2Major Independent Study Underscores Utility of deCODE MI(TM) for Better Predicting Risk of Heart Attack, Informing Statin Therapy 2Major Independent Study Underscores Utility of deCODE MI(TM) for Better Predicting Risk of Heart Attack, Informing Statin Therapy 3Major Independent Study Underscores Utility of deCODE MI(TM) for Better Predicting Risk of Heart Attack, Informing Statin Therapy 425 Short Films About Top-Level Research on swissinfo.ch 2
(Date:4/17/2014)... State University engineer has developed a patented technique ... explosive devices. The same technique could help police ... M. and Kay L. Theede chair in engineering ... and his research team have created a template-based ... car trunks. The distance detection method called ...
(Date:4/17/2014)... Calif. One day about eight years ago, ... California, Riverside, and her father were on a field trip ... upon an orchid they had never seen before. , Unable ... on orchids. The orchid turned out to be an ... Lophiaris silverarum . , "Lophiaris" is the genus name, ...
(Date:4/17/2014)... is available in German . ... the protection money demanded of him, he can expect his ... however, as fear of the consequences is enough to make ... parasitic birds, which lay their eggs in other birds, nests. ... brood parasites take their revenge by destroying the entire nest. ...
Breaking Biology News(10 mins):Patented research remotely detects nitrogen-rich explosives 2Orchid named after UC Riverside researcher 2Orchid named after UC Riverside researcher 3Fear of the cuckoo mafia 2Fear of the cuckoo mafia 3
... from Murdoch Childrens Research Institute and the University of ... for peanut allergy. It is hoped the test ... approaches and minimise over-diagnosis of peanut allergy in the ... is the standard for diagnosing peanut allergy, and while ...
... a sandstorm over Saudi Arabia, Qatar, Bahrain and southern Iraq and ... first captured on 10 March and the second on 18 March. ... Gulf States in recent days, extending some 1500 km north to ... whipped up dust and sand, causing low visibility and grounding flights ...
... Australian scientist will bring effective screening for tuberculosis (TB) a ... now lives and works. , We still don,t know why ... the Mycobacteria tuberculosis bacterium become sick with tuberculosis ... worldwide every year three every minute. , Centenary Institute ...
Cached Biology News:Test to improve peanut allergy diagnosis 2Young researcher taking fight against global killer to the next level in Vietnam 2
...
... the Adept CE 4100 high pressure dual piston ... wavelength detector for added flexibility. The ... and interface unit, CE 4901., The CE 4901 ... be used with Windows 98 and 2000, offers ...
Bis-Acrylamide (bis) is a monomer used as a crosslinker with acrylamide to form polyacrylamide electrophoretic gels. This 2% bis solution is supplied as 500 ml....
... G|2 Doublestain System is a high-sensitivity ... kit. The kit is intended for ... detection of two different antigens within ... with suitably diluted rabbit and mouse ...
Biology Products: