Genasense Data in Melanoma to be Presented in Opening Session at First Worldwide Melanoma Center Meeting of the European Association of Dermato-Oncology
Barcelona Hosts Key Investigator Meeting for European
Participants in Phase 3 AGENDA Trial Targeting Biomarker-Defined
Population
BERKELEY HEIGHTS, NJ – September 5, 2007 – Genta
Incorporated (Nasdaq: GNTA) announced that data from the
Company’s Phase 3 trial of Genasense® (oblimersen sodium)
plus chemotherapy would be presented at the opening session of the
first Worldwide Melanoma
Center Meeting organized by the European Association of
Dermato-Oncology (EADO). Genta, which is a Silver Level sponsor of
the EADO meeting, will also host its key investigator meeting for
European participants in the Company’s ongoing Phase 3 trial
of Genasense in advanced melanoma. The Genasense clinical results
will be presented by Dr. Claus Garbe, who is Chair of the Congress,
and Professor of Dermatology and Head of the Division of
Dermatooncology, Department of Dermatology, University Medical
Center, Tübingen, Germany. The EADO, which is the lead
international cooperative group for the current Phase 3 trial, is
meeting this week in Barcelona, Spain.
The new Genasense trial, known as AGENDA, is a randomized,
double-blind, placebocontrolled study in which patients are
randomly assigned to receive Genasense plus dacarbazine (DTIC) or
DTIC alone. AGENDA is designed to confirm the safety and efficacy
of Genasense when combined with DTIC in patients who have not
previously received chemotherapy. The trial will accrue
approximately 300 patients who have been defined using a biomarker
and will be conducted at approximately 100 sites worldwide,
including North America, Europe and Australia. Patient enrollment
into AGENDA has been initiated.
About Genasense in Advanced Melanoma
Genasense, Genta’s lead anticancer drug, is a novel targeted
therapy that blocks the production of Bcl-2, a protein that appears
to be a fundamental caus e of cancer treatment resistance. By
knocking down Bcl-2, Genasense may enhance the effectiveness of
chemotherapy in patients with advanced melanoma. Genasense in
melanoma has Orphan Drug designations in Australia and the U.S.,
along with Fast Track designation in the U.S.
In its initial Phase 3 trial, Genta performed the largest
randomized controlled trial that has ever been conducted in
patients with advanced melanoma. In that trial, 771 patients were
randomly assigned to receive chemotherapy with DTIC alone or in
combination with Genasense. A
scientific article that describes efficacy and safety results from
this study can be accessed at:
http://www.jco.org/cgi/content/abstract/JCO.2006.06.0483v1.
In that trial, patients were prospectively stratified according to
levels of a blood enzyme known as LDH. Further analysis of this
study showed that maximum benefit accrued to patients whose LDH
biomarker did not exceed 80% of the upper limit of normal. Efficacy
results in this group of 274 patients, which are the focus of the
confirmatory AGENDA trial, are displayed in the table below. (The
hazard ratios indicate that the addition of Genasense to DTIC was
associated with a 42% reduction in the risk of disease progression
and a 36% reduction in risk of death.)
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 Melanoma
Malignant melanoma is the most deadly form of skin cancer. The
incidence of this disease is increasing by approximately 4%
annually in the U.S. In 2004, the American Cancer Society estimates
more than 55,000 cases of malignant melanoma will have been
diagnosed. Melanoma is the number one cause of cancer death in
women aged 25 to 29. More information about melanoma can be
accessed at the Melanoma Research Foundation: http://www.melanoma.org.
About the EADO
The EADO is an international cooperative group dedicated to
promote, coordinate and improve clinical and laboratory research
activities in skin cancer. Further information about the EADO can
be viewed at: http://www.eado.org/.
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. The
Company’s research platform is anchored by two major programs
that center on oligonucleotides
(RNA- and DNA- based medicines) and small molecules. Genasense®
(oblimersen sodium) Injection is the Company's lead compound from
its oligonucleotide 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. Genta is partnered with IDIS
(www.idispharma.com) on a program
whereby both 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, and the Company’s
ability to obtain sufficient financing to maintain the
Company’s planned operations;
· the adequacy of the Company’s patents
and proprietary rights;
· the impact of litigation that has been brought
against the Company and its officers and directors 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 2006 and its most recent quarterly report
on Form 10-Q.
CONTACT:
For Genta Incorporated
Tara Spiess
TS Communications Group, LLC
(908) 286-3980
info@genta.com
200 Connell Drive
Berkeley Heights, NJ 07922
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