Navigation Links
DSMB Supports Continuation of Phase 3 AGENDA Trial of Genasense(R) in Advanced Melanoma

Completion of Target Enrollment Expected in Fourth Quarter

BERKELEY HEIGHTS, N.J., March 31 /PRNewswire-FirstCall/ -- Genta Incorporated (Nasdaq: GNTA) announced that the Data Safety Monitoring Board (DSMB) for AGENDA, a Phase 3 trial of Genasense (oblimersen sodium) Injection, which is the Company's lead oncology product, has recommended that the trial be continued as originally planned after initial review of blinded safety data from the study.

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.

At the end of the first quarter, the trial had accrued approximately 50 patients with approximately 60% of planned investigative sites having been initiated. Countries with sites currently open for enrollment include the U.S., Canada, Australia, France, Germany, Austria, and the Czech Republic. The trial is planned to open at approximately 90 sites worldwide, and most remaining sites are expected to initiate within the next 30 days. Target accrual of 300 patients is expected to complete in the fourth quarter of 2008, with initial data expected shortly thereafter.

"Investigator enthusiasm for AGENDA is quite high, and we are currently recruiting at our expected rate," said Dr. Loretta M. Itri, M.D., Genta's President, Pharmaceutical Development. "We believe the current rate, combined with enrollment from new sites that will open in the near future, should allow us to maintain our timelines for completion of accrual."


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 is readily detected in blood. Analysis of the previous efficacy outcomes observed in 274 patients from GM301, which AGENDA is designed to confirm, yielded the following results:

Endpoint Genasense/DTIC DTIC Ratio P

Overall response 20.8% 7.2% 0.002

Durable response 10.7% 2.4% 0.007


survival, median 3.6 mos. 1.6 mos. 0.58 <0.0001

Overall survival,

median 12.3 mos. 9.9 mos. 0.64 0.0009

A scientific article that describes efficacy and safety results from GM301 can be accessed at:

About Genta

Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. Two major programs anchor the Company's research platform: DNA/RNA-based Medicines and Small Molecules. Genasense(R) (oblimersen sodium) Injection is the Company's lead compound from its DNA/RNA Medicines program. Genta is currently recruiting patients to the AGENDA Trial, a global Phase 3 trial of Genasense in patients with advanced melanoma. The leading drug in Genta's Small Molecule program is Ganite(R) (gallium nitrate injection), which the Company is exclusively marketing in the U.S. for treatment of symptomatic patients with cancer related hypercalcemia that is resistant to hydration. The Company has developed G4544, an oral formulation of the active ingredient in Ganite, that has recently entered clinical trials as a potential treatment for diseases associated with accelerated bone loss. The Company is also developing tesetaxel, a novel, orally absorbed, semi- synthetic taxane that is in the same drug class as paclitaxel and docetaxel. Ganite and Genasense are available on a "named-patient" basis in countries outside the United States. For more information about Genta, please visit our website at:

Safe Harbor

This press release may contain forward-looking statements with respect to business conducted by Genta Incorporated. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Forward- looking statements include, without limitation, statements about:

-- the Company's ability to obtain necessary regulatory approval for

Genasense(R) from the U.S. Food and Drug Administration ("FDA") or

European Medicines Agency ("EMEA");

-- the safety and efficacy of the Company's products or product


-- the Company's assessment of its clinical trials;

-- the commencement and completion of clinical trials;

-- the Company's ability to develop, manufacture, license and sell its

products or product candidates;

-- the Company's ability to enter into and successfully execute license

and collaborative agreements, if any;

-- the adequacy of the Company's capital resources and cash flow

projections, and the Company's ability to obtain sufficient financing

to maintain the Company's planned operations;

-- the adequacy of the Company's patents and proprietary rights;

-- the impact of litigation that has been brought against the Company

and its officers and directors and any proposed settlement of such


-- the Company's ability to retain compliance with the NASDAQ's listing

qualifications; and

-- the other risks described under Certain Risks and Uncertainties

Related to the Company's Business, as contained in the Company's

Annual Report on Form 10-K and Quarterly Report on Form 10-Q.

The Company does not undertake to update any forward-looking statements. There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the Company's Annual Report on Form 10-K for 2007 and its most recent quarterly report on Form 10-Q.


Nichol Harber

Genta Investor Relations


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

Related medicine technology :

1. DSMB Again Supports Continuation of the Phase III Clinical Trial of Medidur(TM) FA for the Treatment of DME
2. Evanston Northwestern Healthcare Researchers Explain Effects of Large-Scale, Universal MRSA Surveillance Program That Supports Expanded Intervention
3. ACR Supports American Cancer Society Inclusion of CT Colonography (Virtual Colonoscopy) as Recommended Screening Tool for Colorectal Cancer in New Screening Guidelines
4. New Clinical Data Further Supports Chromium Picolinates Role in Enhancing Brain Activity in Older Adults
5. HUYA Bioscience Intl Announces Clinical Trial Milestones in China for Promising New Anti-Arrhythmic Compound; Data Supports Desirable Safety Profile
6. FDA Advisory Committee Supports Efficacy and Safety of Zyprexa(R) Long-Acting Injection (LAI) for Schizophrenia Treatment
7. Interim Analysis Supports Continuation of Cell Genesys VITAL-1 Phase 3 Clinical Trial of GVAX Immunotherapy for Prostate Cancer
8. Interim Safety Analysis Supports Continuation of Allos Therapeutics Pivotal Phase 2 PROPEL Trial of PDX in Patients with Peripheral T-cell Lymphoma
9. Powerful New Efficacy Data in Moderate and Severe Hypertensive Patients Supports FDA Approval of AVALIDE(R) (Irbesartan-Hydrochlorothiazide) as the First Combination Therapy for Initial Use in Patients Likely to Need Multiple Drugs to Achieve Their Blood
10. New Data from the Framingham Heart Study Supports PAT Technology to Diagnose Early Cardiovascular Disease
11. Cost-Effectiveness Study Supports Use of EUFLEXXA(TM) by Rheumatologists for Pain Relief in Patients with Knee Osteoarthritis
Post Your Comments:
(Date:11/29/2015)... Nov. 29, 2015  The GE Health Cloud 1 ... Society of North America (RSNA) meeting ... healthcare industry, the new cloud ecosystem and its applications will ... care pathways and multidisciplinary teams – both inside and outside ... and CEO of GE. "As the digital industrial leader, we ...
(Date:11/27/2015)... 27, 2015 Une nouvelle ... au Bremachlorin contre le cancer avancé.    ... combiner l,immunothérapie au traitement photodynamique au Bremachlorin contre ... Une nouvelle approche consistant à combiner l,immunothérapie ... avancé.    Clinical Cancer Research ...
(Date:11/27/2015)... 2015  Lannett Company, Inc. (NYSE: LCI ... acquisition of Kremers Urban Pharmaceuticals Inc. (KU), the ... company UCB S.A. (Euronext: UCB). ... KU from UCB for total consideration of approximately ... customary working capital adjustment, a deduction of certain ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... November 28, 2015 , ... There is only one major question facing ... last year? , This question has not been an easy question to answer. Especially ... age and the younger workforce don’t share the same discipline around working long hours. ...
(Date:11/27/2015)... Angeles, CA (PRWEB) , ... November 27, 2015 , ... ... study carried out by the University of Toronto and the University of British Columbia ... of hospitalizations for head injuries. The article explains that part of the reason for ...
(Date:11/27/2015)... ... November 27, 2015 , ... The ... in America. As people age, more care is needed, especially with Alzheimer’s, dementia ... medical professionals are being overworked. The forgotten part of this equation: 80 percent ...
(Date:11/27/2015)... ... November 27, 2015 , ... An inventor, ... to dispense prescription medications at home, so he invented the patent-pending ELECTRONIC M.D. ... dispense prescription medications. In doing so, it could help to prevent potential overdose ...
(Date:11/27/2015)... CA (PRWEB) , ... November 27, 2015 , ... Lizzie’s ... , The company is offering customers 10% off of their purchase of lice treatment ... treatment at full price. According to a company spokesperson. “Finding lice is a sure ...
Breaking Medicine News(10 mins):