- AGENDA Trial Passes Futility and Safety
Analysis
- Intent-to-File Notice Submitted to EMEA
BERKELEY HEIGHTS, NJ - May 19, 2009
- Genta Incorporated (OTCBB: GNTA.OB) today announced that the
independent Data Monitoring Board (DMB) for AGENDA, a randomized
Phase 3 trial of Genasense® in patients with advanced melanoma, has
informed the Company that the study has passed its final futility
analysis for progression-free survival (PFS).
Accordingly, the Board has recommended that the study should
continue to completion.
Coincident with this recommendation, Genta has submitted an
"intent-to-file" notice via the centralized procedure to the
European Medicines Agency (EMEA), along with a request for
assignment of rapporteurs. Such notice is required prior to
submission of a Marketing Authorization Application (MAA).
"Futility analyses after completing accrual have been occasions
for failure of two other Phase 3 melanoma drugs earlier this year,"
said Dr. Raymond P. Warrell, Jr., Genta's Chief Executive
Officer. "Having announced enrollment completion last month,
we are greatly pleased with this report from the DMB for
AGENDA. The next milestone is release of final data on
progression-free survival (PFS), which is expected in the 4th
quarter of this year. If positive, we expect our regulatory
applications for Genasense will be based on statistically
significant and clinically meaningful improvements in PFS."
AGENDA is a randomized double-blind trial in 315 patients with
advanced melanoma. The study is designed to confirm certain
safety and efficacy results from a previous randomized trial of
Genasense combined with dacarbazine in patients who have not
previously received chemotherapy. 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, a tumor-derived enzyme that is readily
detected in blood. In large trials like AGENDA, one or more
analyses for "futility" are commonly conducted by an independent
committee to determine whether there is no longer a reasonable
chance that a trial will achieve its major endpoints. AGENDA
has co-primary endpoints of PFS and overall survival (OS), and
subsequent futility analyses for OS are planned if the PFS endpoint
is achieved. AGENDA is intended to support global
registration of Genasense for patients with advanced melanoma.
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 to evaluate 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:
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)
or 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;
- 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
