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: 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:
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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;
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the safety and efficacy of the Company’s products or product
candidates;
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the Company’s assessment of its clinical trials;
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the commencement and completion of clinical trials;
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the Company’s ability to develop, manufacture, license and sell its
products or product candidates;
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the Company’s ability to enter into and successfully execute and
maintain license and collaborative agreements;
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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;
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the adequacy of the Company’s patents and proprietary rights;
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the impact of litigation that has been brought against the Company;
and
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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.
