Genta Incorporated (OTCBB: GNTA) announced the presentation of a
progress update on the Company’s ongoing Phase 3 trial of Genasense®
(oblimersen sodium) Injection, Genta’s lead oncology product, in
patients with advanced melanoma. The data were presented in conjunction
with the 27th Annual JP Morgan Healthcare Conference in San Francisco,
CA.
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 who have not
previously received chemotherapy and who are identified by a biomarker
(low-normal levels of lactate dehydrogenase [LDH]). The co-primary
endpoints of AGENDA are progression-free survival (PFS) and overall
survival. The trial is being led by the EADO in Europe and by the M.D.
Anderson Cancer Center, Houston, TX in the U.S.
To date, more than three-quarters of the expected total number of 300
patients have been randomized into AGENDA. A total of 77 sites in 12
countries are open in Europe, the U.S., Canada, and Australia. As shown
in the tables below, updated preliminary information on patient
characteristics and safety findings in approximately two-thirds of
patients accrued to AGENDA are similar to those in the biomarker-defined
population that was accrued in the previous Phase 3 trial of Genasense,
known as GM301. The incidence of serious adverse events (SAEs) in AGENDA
has been somewhat lower, which may reflect the double-blind design of
AGENDA compared with the open-label design of GM301.
"We have made very substantial progress in accrual and have noted
similar patient demographics in the completed and ongoing trials”, said
Dr. Loretta M. Itri, Genta’s President Pharmaceutical Development, and
Chief Medical Officer. "Overall data from patients in these two
populations, who are not identified as to treatment assignment, also
show good congruence to date for the number and timing of progression
events, which are key components in the PFS co-primary endpoint. We are
grateful for the excellent support we have received from the
investigator community and look forward to the timely completion of
target accrual later this quarter.”
|
Demographic Comparison of Combined Blinded Demographic Data
|
|
|
|
|
|
|
|
|
Demographic Factor
|
|
GM301 (low-normal LDH)
N=274
|
|
|
AGENDA (low-normal LDH)
N=208
|
|
Age, median (years)
|
|
60
|
|
|
58
|
|
Gender (M/F) (%)
|
|
64/36
|
|
|
64/36
|
|
Disease site(s): (%)
|
|
|
|
|
|
|
Skin, soft tissue, lymph nodes
|
|
22
|
|
|
25
|
|
Liver metastases
|
|
21
|
|
|
26
|
|
Other visceral metastases
|
|
57
|
|
|
49
|
|
|
|
|
|
|
|
|
|
Comparison of Combined Blinded Safety Data
|
|
|
|
|
|
|
|
|
|
Treatment-Related SAEs
|
|
|
GM301 (low-normal LDH)
N=259
Percent
|
|
|
AGENDA (low-normal LDH)
N=212
Percent
|
|
Total SAEs
|
|
|
14
|
|
|
10
|
|
Thrombocytopenia
|
|
|
4
|
|
|
3
|
|
Neutropenia
|
|
|
3
|
|
|
< 1
|
|
Anemia
|
|
|
2
|
|
|
< 1
|
|
Bacteremia/septicemia
|
|
|
1
|
|
|
< 1
|
|
Pneumonia
|
|
|
0
|
|
|
< 1
|
|
Pyrexia
|
|
|
4
|
|
|
< 1
|
|
Nausea
|
|
|
2
|
|
|
0
|
About AGENDA
AGENDA is a global Phase 3, randomized, double-blind trial in patients
with advanced melanoma. The study is designed to confirm certain safety
and efficacy results from an antecedent randomized trial of Genasense
combined with dacarbazine (DTIC) in patients who have not previously
received chemotherapy (GM301). 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
(lactate dehydrogenase), a tumor-derived enzyme that is readily detected
in blood. Analysis of those efficacy outcomes in GM301, which were
observed in 274 patients, showed 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
|
A scientific article that describes efficacy and safety results from
GM301 can be accessed at: http://www.jco.org/cgi/content/abstract/JCO.2006.06.0483v1
About the EADO
The EADO is an independent non-profit organization dedicated to promote,
coordinate and improve clinical and laboratory research activities in
the field of skin cancer. The organization has a European and
international membership of dermatologists, oncologists and clinical as
well as basic research scientists interested in the field of
dermato-oncology. EADO provides leadership by formulating and
disseminating quality standards and guide-lines for diagnosis and
treatment of skin cancer, and it provides direction, coordination and
organizations of clinical, therapeutic, and experimental trials.
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 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, 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 approvals for
Genasense® or its other 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 2007 and its most recent quarterly report on Form 10-Q.