Genta Incorporated (OTCBB: GNTA) announced the presentation of a
progress update from the Company’s ongoing
Phase 3 trial of Genasense® (oblimersen
sodium) Injection, Genta’s lead oncology
product, in patients with advanced melanoma. A pooled analysis of data
from this study, which remains blinded, was compared with the Company’s
previous data from a similarly designed randomized trial. The
comparative analysis shows that to date AGENDA has enrolled patients
with similar demographics, and also that the aggregate incidence of
serious adverse events is comparable. The data were presented this past
weekend by Dr. Agop Bedikian at an international symposium entitled Perspectives
in Melanoma XII in The Hague, The Netherlands.
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 is designed to confirm
certain safety and efficacy results from Genta’s
prior randomized trial of Genasense combined with dacarbazine (DTIC) in
patients identified by a biomarker who have not previously received
chemotherapy. The co-primary endpoints of AGENDA are progression-free
survival and overall survival.
To date, approximately 60% of the planned 300 patients have been
accrued. Target accrual of 300 patients is expected to complete in the
first quarter of 2009. Clinical characteristics of the first 150
patients accrued to AGENDA (not identified by treatment group) were
shown to be similar to the biomarker-defined population that was accrued
in the previous Phase 3 trial of Genasense, known as GM301. Moreover,
the overall incidence of serious adverse events in AGENDA has been
comparable to this population in the preceding trial.
"AGENDA is probably the most important Phase 3
trial currently open for patients with advanced melanoma, said Dr.
Bedikian, Professor, Melanoma Medical Oncology, and Associate Clinical
Medical Director, Melanoma/Skin Center at the M.D. Anderson Cancer
Center, Houston, TX. "With enrollment winding
to a close in the very near future, we are eagerly looking forward to
our next study with Genasense that will use the newly designed short
infusion schedule, and to the results from AGENDA that are expected in
2009.”
About AGENDA
AGENDA is a global Phase 3, randomized, double-blind trial in patients
with advanced melanoma. The study is designed to confirm certain safety
and efficacy results from an antecedent 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 article that describes efficacy and safety results from
GM301 can be accessed at: http://www.jco.org/cgi/content/abstract/JCO.2006.06.0483v1.
About Genasense
Genasense inhibits production of Bcl-2, a protein made by cancer cells
that is thought to block a key pathway of chemotherapy-induced cell
death (apoptosis). 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 drug class 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.
Forward-looking statements include, without
limitation, statements about:
-
the Company’s ability to obtain
necessary regulatory approval for Genasense®
from the U.S. Food and Drug Administration ("FDA”)
or European Medicines Agency ("EMEA”);
-
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 if it is unsuccessful in obtaining such financing or in
securing shareholder approval to increase the number of shares
authorized for issuance under the Company’s
certificate of incorporation, as required by the transactional
documents in our recent financing;
-
the adequacy of the Company’s patents
and proprietary rights;
-
the impact of litigation that has been brought against the Company
and any proposed settlement of such litigation; 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.
The Company does not undertake to update any forward-looking
statements.
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 2007 and its most recent quarterly report on Form 10-Q.