New Publication Confirms Critical Link of LDH Biomarker in Genasense® Trials to Overall Survival in Advanced Melanoma
14 Juli 2009 - 2:00PM
Business Wire
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, which 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: 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.