Genta Updates Progress of its Phase 3 Trial of Genasense(R) in Patients with Advanced Melanoma
24 Junio 2008 - 7:00AM
PR Newswire (US)
Clinical Study on Track to Complete Accrual in Fourth Quarter 2008
BERKELEY HEIGHTS, N.J., June 24 /PRNewswire-FirstCall/ -- Genta
Incorporated (OTC:GNTA) (BULLETIN BOARD: GNTA) announced the
presentation of a progress update from an ongoing Phase 3 trial of
Genasense(R) (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: Hazard Endpoint
Genasense/DTIC DTIC Ratio P Overall response 20.8% 7.2% 0.002
Durable response 10.7% 2.4% 0.007 Progression-free 3.6 mos. 1.6
mos. 0.58 < 0.0001 survival, median Overall survival, 12.3 mos.
9.9 mos. 0.64 0.0009 median 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(R) (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(R)
(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 drug
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(R) 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, the Company's ability to obtain sufficient
financing to maintain the Company's planned operations, or the
Company's risk of bankruptcy if it is unsuccessful in obtaining
such financing or in securing shareholder approval to increase the
number of shares authorized for issuance under the Company's
certificate of incorporation, as required by the transactional
documents in our recent financing; -- 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 2007 and its most recent quarterly report on Form 10-Q.
CONTACT: Genta Investor Relations DATASOURCE: Genta Incorporated
CONTACT: Genta Investor Relations, +1-908-286-3980, Web site:
http://www.genta.com/
http://www.jco.org/cgi/content/abstract/JCO.2006.06.0483v1
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