Related Clinical Study Shows Potential Utility of
Short-Course High-Dose Therapy
BERKELEY HEIGHTS, NJ - May 30, 2008
- Genta Incorporated (OTCBB: GNTA) announced preliminary
results that have shown a high objective response rate in a pilot
study that incorporates the Company's lead oncology product,
Genasense® (oblimersen sodium) Injection, in a chemotherapy program
for patients with advanced melanoma. In this study, Genasense
was used to potentially enhance the clinical activity of
temozolomide (Temodar®; Schering Plough, Inc.), the most commonly
used anticancer drug for melanoma, combined with Abraxane®
(paclitaxel protein-bound particles for injectable suspension;
Abraxis Bioscience, Inc.). The data will be featured in a
presentation at the annual meeting of the American Society of
Clinical Oncology (ASCO) in Chicago on June 1, 2008.
All 14 of the first cohort of patients accrued to this study had
non-resectable stage 4 melanoma. None had previously received
chemotherapy, and their baseline LDH did not exceed 1.1 times the
upper limit of normal. (LDH is a tumor-derived blood marker
that was shown to affect the response to Genasense plus
chemotherapy in a recent randomized trial.) To date, 6
patients (43%) have achieved major objective responses: one with
complete response (CR) after 6 cycles of treatment, and 5 with at
least a partial response after only one treatment cycle.
Three additional patients have maintained stable disease (SD) after
at least three treatment cycles, for an overall clinical benefit
response (CR+PR+SD) of 64%.
Laboratory studies showed that Genasense did not alter the
expected pharmacokinetics of paclitaxel, and that clinical response
was associated with alterations in Bcl-2, a protein that is the
molecular target of Genasense. No dose-limiting toxicity was
observed. The most commonly observed side-effects were
similar to those encountered with the chemotherapy drugs used
alone, including leukopenia, thrombocytopenia, and hair
loss.
In a related study accepted for publication at ASCO, a Phase 1
study showed that Genasense could be safely administered on a
twice-weekly basis for 3 consecutive weeks at a dose of 900 mg/m2
infused intravenously (IV) over two hours. An amendment to
the above pilot trial in melanoma is planned that will incorporate
this more convenient treatment schedule.
"While preliminary, we believe these initial data are very
promising," said Dr. Raymond P. Warrell, Jr., Genta's Chairman and
Chief Executive Officer. "Temozolomide is the active
metabolite of dacarbazine (DTIC), which is the chemotherapy drug
used in our ongoing Phase 3 AGENDA trial in patients with melanoma
and low-normal LDH. We also plan that melanoma will be a
target for our development program with tesetaxel, the Company's
novel orally absorbed taxane, thus potentially affording patients a
highly convenient treatment program for this intractable
disease."
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 (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.
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 US. 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. 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 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 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
