BERKELEY HEIGHTS, NJ - April 23, 2009
- Genta Incorporated (OTCBB: GNTA.OB) announced today that
data from clinical trials of the Company's late-stage compounds,
Genasense® (oblimersen sodium) Injection and tesetaxel, will be
presented at the 2009 American Society of Clinical Oncology (ASCO)
Annual Meeting. The meeting will be held from May 29- June 2,
2009 in Orlando, FL.
Genta has now completed enrollment into AGENDA, the second of
two large randomized Phase 3 trials of Genasense plus dacarbazine
chemotherapy in patients with advanced melanoma. In parallel, the
Company has also sponsored a pilot dose-ranging study in advanced
melanoma using Genasense combined with different chemotherapy,
including Temodar® (temozolomide; Schering Plough, Inc.) plus
Abraxane® (paclitaxel protein-bound particles for injectable
suspension) [albumin bound]; Abraxis Oncology, Inc.). This
trial employs a new brief intravenous infusion schedule for
Genasense, as well as a biomarker for targeting patient selection
similar to that employed in AGENDA. At ASCO, results of
long-term survival from this pilot non-randomized trial will be
reported.
Genta has also sponsored a clinical and pharmacokinetic study of
tesetaxel, a leading oral taxane in clinical development, in
patients with advanced cancer who were treated at doses up to and
including the maximally tolerated dose. Prior trials have
employed tesetaxel dosed according to height and weight parameters
(i.e., milligrams of drug per square meter of body surface area)
that are difficult to precisely administer in clinical practice
using an oral drug. At ASCO, dosing and pharmacokinetic data
based on conversion of tesetaxel from weight-based to flat dosing
(e.g., a prescribed single dose of 50 mg) will be presented.
Titles, dates and times of these presentations appear below.
Survival of advanced melanoma patients with normal LDH
treated with oblimersen, temozolomide, and nab-paclitaxel
. (Abstract #9080). Monday June 1, 2009. Poster
Session: Melanoma/Skin Cancer: 8 am-12 pm
Pharmacology and safety factors affecting use of flat
(rather than weight-based) dosing of tesetaxel, an orally
administered taxane.
(Abstract #2510). Monday June 1, 2009. Poster
Session: Developmental Therapeutics: 2-6 pm; Discussion Session:
5-6 pm.
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 marketing and reimbursement
approvals for its products from the U.S. Food and Drug
Administration ("FDA") and other regulatory or governmental
authorities;
- 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
and maintain license and collaborative agreements;
- 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
