Related Clinical Study Shows Potential Utility of Short-Course High-Dose Therapy BERKELEY HEIGHTS, N.J., May 30
BERKELEY HEIGHTS, N.J., May 30 /PRNewswire-FirstCall/ -- Genta
Incorporated (OTC Bulletin Board: 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(R) (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(R); Schering Plough, Inc.), the most commonly used
anticancer drug for melanoma, combined with Abraxane(R) (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 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: 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;
-- 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
info@genta.com
SOURCE Genta Incorporated
