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.
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.
