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
Ratio
|
|
P
|
|
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.