Clinical Study on Track to Complete Accrual in Fourth Quarter
2008
BERKELEY HEIGHTS, NJ - June 24, 2008
- Genta Incorporated (OTCBB: GNTA) announced the presentation
of a progress update from an ongoing Phase 3 trial of Genasense®
(oblimersen sodium) Injection, the Company's lead oncology product,
in patients with advanced melanoma. The data were presented
at a satellite investigator's meeting held in conjunction with the
Adjuvant Melanoma Congress sponsored by the European Association of
Dermato-Oncology (EADO) in Marseille, France on June 21, 2008.
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 identified by a
biomarker who have not previously received chemotherapy. The
co-primary endpoints of AGENDA are progression-free survival 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 one-third of the expected total number of
patients have now been randomized onto the AGENDA trial. A
total of 83 sites in 12 countries have been opened in Europe, the
U.S., Canada, and Australia. Clinical characteristics of the
first 70 patients accrued to AGENDA (not identified by treatment
group) were shown to be similar to the biomarker-defined population
accrued in the previous Phase 3 trial of Genasense, known as
GM301. The incidence of serious adverse events in AGENDA has
been somewhat lower, which probably reflects the routine use of
prescribed supportive care for all patients, as well as the
double-blind design of AGENDA compared with the open-label design
of GM301. Target accrual of 300 patients is expected to
complete in the fourth quarter of 2008, with initial data expected
shortly thereafter.
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 the
promotion, coordination, and improvement of clinical and laboratory
research activities in the field of skin cancer. The organization
has an 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, 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. 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;
- the Company's ability to retain compliance with the NASDAQ's
listing qualifications; 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 2007 and its most recent
quarterly report on Form 10-Q.
SOURCE: Genta Incorporated
CONTACT:
Genta Investor Relations
908-286-3980
info@genta.com
