BERKELEY HEIGHTS, NJ - July 14, 2009
- Genta Incorporated (OTCBB: GETA.OB) announced publication
of a paper that independently confirms the link of a key biomarker
to overall survival in patients with advanced melanoma. The
biomarker, a tumor-derived enzyme known as lactate dehydrogenase
(LDH), is measured by a widely available blood test. Genta's
recently completed Phase 3 trial of Genasense® in advanced
melanoma, known as AGENDA, specified low-normal LDH as an
enrollment criterion. Results for progression-free
survival (PFS), a co-primary endpoint of AGENDA, are anticipated in
the Fourth Quarter of this year. If positive, the AGENDA
results are expected to support global regulatory applications for
Genasense® in this indication.
A previous randomized Phase 3 trial compared outcomes of
patients with advanced melanoma who were treated using standard
chemotherapy (dacarbazine) with and without Genasense® (oblimersen
sodium) Injection, the Company's lead anticancer
compound. This trial showed that overall survival (OS)
was strongly associated with baseline levels of LDH. While
high levels of LDH have long been associated with poor outcome in
melanoma and other cancers, the Genasense study showed a
significant interaction with treatment outcome in a prospectively
stratified randomized trial. A scientific article that
describes efficacy and safety results from that study can be
accessed here:
http://www.jco.org/cgi/content/abstract/JCO.2006.06.0483v1
.
The new publication describes the statistical model that first
elucidated an association between increasingly elevated levels of
LDH and inferior OS in the previous trial, along with the
prospective application of that model to data derived from a recent
trial conducted by the European Organization for Research and
Treatment of Cancer (EORTC), the largest European oncology
cooperative group. The EORTC randomized patients with
advanced melanoma to drug combinations that did not employ
Genasense and showed no between-treatment differences. The
investigators then aggregated data from their study to test the
hypothesis generated in the Genasense trial: namely, that OS in
advanced melanoma is inversely associated with increasingly
elevated levels of LDH.
The new analysis from the EORTC trial confirmed that association
and showed results that were highly congruent with observations
from the Genasense study. Moreover, the EORTC analysis also
confirmed that this association extended into the normal range:
specifically, patients with low-normal LDH had extended survival,
an observation first established in the Genasense study.
Thus, the EORTC analysis provides strong and independent
confirmation of the association between survival and LDH
levels. The new information appears in the
July issue of the European Journal of Cancer. An abstract of
the publication can be viewed here:
http://www.ejcancer.info/article/S0959-8049(09)00282-2/abstract
.
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 is designed to confirm certain safety and
efficacy results from Genta's prior randomized trial of Genasense
combined with dacarbazine in patients who have not previously
received chemotherapy and who are identified by a biomarker
(low-normal levels of LDH). The co-primary endpoints of
AGENDA are PFS and OS. The trial has completed accrual of 315
patients. PFS results - a co-primary endpoint in this trial
-- are anticipated in the Fourth Quarter of 2009.
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");
- 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
