BERKELEY HEIGHTS, NJ - April 7, 2009
- 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 efficacy and safety
results the prior study (GM301) can be accessed at:
http://www.jco.org/cgi/content/abstract/JCO.2006.06.0483v1
. 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
innovative products
research platform
Genasense® (oblimersen sodium)
Ganite® (gallium nitrate
injection)
G4544
tesetaxel
named-patient
http://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.
SOURCE: Genta Incorporated
CONTACT:
Genta Investor Relations
info@genta.com