FDA Appeal Decision Indicates that Genasense® Approval in Chronic Lymphocytic Leukemia Will Require Additional Confirmatory Trial

Fri Mar 6, 2009 6:34pm EST

* Reuters is not responsible for the content in this press release.

BERKELEY HEIGHTS, N.J.--(Business Wire)--
Genta Incorporated (NASDAQ: GNTA) announced that the Food and Drug
Administration`s (FDA) Center for Drug Evaluation and Research (CDER) has
decided that available data are not adequate to support approval of Genasense®
(oblimersen sodium) Injection for treatment of patients with relapsed or
refractory chronic lymphocytic leukemia (CLL). In a decision issued in response
to an appeal filed by Genta in December 2008, CDER concluded that new
information submitted by the Company in its amended New Drug Application (NDA)
was insufficient, and the Agency has recommended conducting a confirmatory
clinical trial. 

"While disappointed with this decision, we appreciate FDA`s clarification of the
path to U.S. regulatory approval in this important indication," commented Dr.
Loretta M. Itri, Genta`s President, Pharmaceutical Development, and Chief
Medical Officer. "The Company will discuss this decision with clinical and
regulatory authorities before determining our next steps. Genta greatly
appreciates the professional and collaborative communications with FDA during
this process, and we look forward to working with FDA in addressing their
recommended options for securing the confirmatory data." 

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.
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 (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. 


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.

Investor Relations, 908-286-3980

Copyright Business Wire 2009

Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.