One-hour Infusion Schedule to be Tested in Next Cohort
BERKELEY HEIGHTS, NJ - June 3, 2009
- Genta Incorporated (OTCBB: GNTA.OB) announced preliminary
results that show a high objective response rate and potentially
extended survival in an ongoing pilot study that incorporates the
Company's lead oncology product, Genasense® (oblimersen sodium)
Injection, in a chemotherapy program for patients with advanced
melanoma. The data were featured this week in a presentation
at the annual meeting of the American Society of Clinical Oncology
(ASCO) in Orlando, FL.
Based on preclinical evidence of synergy, Genasense was combined
with temozolomide (Temodar®; Schering Plough, Inc.), the most
commonly used anticancer drug for melanoma, plus ABRAXANE® for
Injectable Suspension (paclitaxel protein-bound particles for
injectable suspension) [albumen bound]; Abraxis Bioscience,
Inc.).
To date, 18 patients have been accrued, all of whom had
unresectable 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 biomarker that
has been associated with outcome in melanoma and other
diseases.) To date, 7 patients (39%) have achieved major
objective responses: one with complete response (CR) after 6 cycles
of treatment, and 6 with at least a partial response after a
minimum of 2 treatment cycles. Five patients have maintained
stable disease (SD) after at least 3 treatment cycles (24 weeks),
for an overall disease control rate (CR+PR+SD) of 68%. The
most commonly observed side-effects were similar to those
associated with the chemotherapy drugs used alone, including
leukopenia, thrombocytopenia, neuropathy, and hair loss.
Overall median survival for all patients irrespective of
response was 14.7 months, and 50% of patients have survived greater
than 1 year. The patient who achieved a complete response has
stopped all therapy and remains without recurrence for 20+
months. The single patient with ocular melanoma, a rare and
highly aggressive subtype, survived for 15 months. These data
compare very favorably with median survival reported in the
randomized Phase 3 trial of patients with advanced melanoma and
similar LDH criteria using dacarbazine alone (9.7 months) or
dacarbazine plus Genasense (11.4 months) (Bedikian A, et al., J
Clin Oncol. 24:4738, 2006).
"These initial data are very promising," said Dr. Loretta M.
Itri, Genta's President, Pharmaceutical Development.
"Temozolomide is the active metabolite of dacarbazine that was used
in our Phase 3 trial (AGENDA) in patients with advanced melanoma
and low-normal LDH. Taxanes are being increasingly used in
patients with metastatic melanoma, and this unique combination may
offer substantial advantages. The next group of patients in
this study will receive Genasense administered over 1 hour twice
per week. This new, more convenient schedule is a key aspect
of our clinical development plan."
About the AGENDA trial in advanced melanoma
Genta has completed patient enrollment into AGENDA, 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 in patients identified by a
biomarker who have not previously received
chemotherapy. The co-primary endpoints of AGENDA are
progression-free survival (PFS) and overall survival. Genta
anticipates that the final analysis of PFS will be available in the
4th quarter 2009, and if clinically meaningful, the Company plans
to submit its regulatory applications based on this outcome
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/
.
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. 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. 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 approval
for Genasense® from the U.S. Food and Drug Administration
("FDA");
- 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;
- 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 2008 and its most recent quarterly report
on Form 10-Q.
SOURCE: Genta Incorporated
CONTACT:
Genta Investor Relations
info@genta.com
