Genta Announces Completion of Patient Enrollment into Global Phase 3 Trial of Genasense® in Advanced Melanoma

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Tue Apr 7, 2009 8:05am EDT

BERKELEY HEIGHTS, N.J.--(Business Wire)--
Genta Incorporated (OTCBB: GNTA.OB) announced that the Company had completed
patient enrollment into AGENDA, a Phase 3 trial of Genasense® (oblimersen
sodium) Injection in patients with advanced melanoma. Final accrual totaled 315
subjects. 

"Completion of this trial represents a major milestone for our Company," said
Dr. Raymond P. Warrell, Jr., Genta`s Chief Executive Officer. "Over the past 10
years, Genta has made a sustained and substantial commitment toward improving
health and outcomes for patients with this devastating illness. This timely
completion of accrual is a tribute to the hard work of our employees, physician
investigators, study coordinators, patients, and families. Their enthusiasm and
the extensive prior data that underlay the planning of this trial offers what we
believe is the most promising and exciting advance in melanoma therapy after
many decades of setbacks. We currently project that the final assessment of
progression-free survival (PFS) will be analyzed approximately 6 months after
the last patient has been enrolled. If positive, we plan discussions with global
regulatory agencies regarding submissions for marketing approval based on this
result coupled with our extensive prior data." 

About AGENDA

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 was designed to confirm certain safety and efficacy results
obtained in a prior randomized trial of Genasense combined with dacarbazine
(DTIC) in patients who have not previously received chemotherapy (GM301). AGENDA
employs a biomarker to define those patients who derived maximum clinical
benefit during the preceding study. These patients are characterized by
low-normal levels of LDH (lactate dehydrogenase), a tumor-derived enzyme that is
readily detected in blood. 

Analysis of those efficacy outcomes in GM301, which were observed in 274
patients, showed the following results:

 Endpoint                             Genasense/DTIC    DTIC        Hazard    P         
                                                                    Ratio               
 Overall response                     20.8%             7.2%                  0.002     
 Durable response                     10.7%             2.4%                  0.007     
 Progression-free 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 publication that describes overall efficacy and safety results from
the prior study (GM301) can be accessed at:
http://jco.ascopubs.org/cgi/content/full/24/29/4738. The co-primary endpoints of
AGENDA are progression-free survival (PFS) and overall survival. 

About Genasense

Genasense inhibits production of Bcl-2, a protein made by cancer cells that is
thought to block chemotherapy-induced apoptosis (programmed cell death). By
reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the
effectiveness of current anticancer treatment. Genta is pursuing a broad
clinical development program with Genasense evaluating its potential to treat
various forms of cancer. 

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 (oblimersen sodium)
Injection is the Company's lead compound from its DNA/RNA Medicines program. The
leading drug in Genta`s Small Molecule program is Ganite (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 class of drugs 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: www.genta.com. 

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.Such
forward-looking statements include those that express plan, anticipation,
intent, contingency, goals, targets, or future developments and/or otherwise are
not statements of historical fact.The words "potentially", "anticipate",
"could", "calls for", and similar expressions also identify forward-looking
statements.The Company does not undertake to update any forward-looking
statements.Factors that could affect actual results include, without limitation,
risks associated with:

* the Company`s ability to obtain necessary regulatory approval for Genasense®
from the U.S. Food and Drug Administration ("FDA");
* the safety and efficacy of the Company`s products or product candidates;
* 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, the
Company`s ability to obtain sufficient financing to maintain the Company`s
planned operations, or the Company`s risk of bankruptcy;
* the adequacy of the Company`s patents and proprietary rights;
* the impact of litigation that has been brought against the Company; 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.

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 2008 and its most recent
quarterly report on Form 10-Q.





Genta Investor Relations
908-286-3980
info@genta.com

Copyright Business Wire 2009

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