AGENDA Trial Expected to Complete Accrual Early
2009
BERKELEY HEIGHTS, NJ - October 6, 2008
- 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.
SOURCE: Genta Incorporated
CONTACT:
Genta Investor Relations
info@genta.com
