BERKELEY HEIGHTS, NJ - September 15, 2008
- Genta Incorporated (OTCBB: GNTA.OB) announced today that the
independent Data Monitoring Board (DMB) for AGENDA, a Phase 3 trial
of the Company's lead oncology product Genasense® (oblimersen
sodium) Injection, has completed its review. During its
review, the DMB evaluated safety data from the study and conducted
an analysis for futility. With more than half of the
initially planned number of patients now enrolled, the Board
recommended that the trial continue to completion of full
enrollment.
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. A total of
300 patients are expected to enroll in AGENDA.
Genta will provide a pooled update of blinded data from AGENDA,
compared with data obtained in this biomarker-defined population
from the Company's previous Phase 3 trial (see below), at an
international scientific meeting, Perspectives in Melanoma XII,
that is scheduled for October 2-4, 2008.
"We remain quite pleased with the high investigator enthusiasm
for AGENDA," said Dr. Loretta M. Itri, M.D., Genta's President,
Pharmaceutical Development. "We currently anticipate that
accrual will complete in the first quarter of 2009."
About AGENDA
AGENDA employs a biomarker to define those patients who derived
maximum clinical benefit during a large randomized study of DTIC
with or without Genasense, known as study GM301. These
patients are characterized by low-normal levels of LDH (lactate
dehydrogenase), a tumor-derived enzyme that is readily detected in
blood. Analysis of the previous efficacy outcomes observed in
274 patients from GM301, which AGENDA is designed to confirm,
yielded 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
|
About the Perspectives in Melanoma Meeting
Held annually, Perspectives in Melanoma XII will provide an
overview of recent advances and rigorous discussions of the most
current and controversial topics in the fields of melanoma
diagnosis and therapy. Led by authorities and current
investigators in the field, the program will explore several of the
most promising new leads from the bench to the clinic. The
conferences will be held October 2-4, 2008 in The Hague, The
Netherlands:
http://www.imedex.com/appweb/announcements/a030-01.asp
.
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
