Genta Incorporated (OTCBB: GNTA.OB) announced it has initiated a new
clinical trial with tesetaxel, the latest addition to Genta’s oncology
product portfolio. Unlike standard taxanes such as paclitaxel (Taxol®),
which must be infused intravenously, tesetaxel is administered by mouth
as a capsule. The new study will examine the clinical pharmacology of
the drug over a narrow dosing range around the established Phase 2 dose.
As a late Phase 2 agent, the Company believes tesetaxel is the leading
oral taxane currently in clinical development.
"Taxanes are the most widely used class of anticancer compounds,”
commented Dr. Loretta M. Itri, Genta’s President, Pharmaceutical
Development, and Chief Medical Officer. "Successful development of an
oral taxane has been a research goal that has eluded many pharmaceutical
companies. Tesetaxel has already been tested in more than 250 patients
with various types of cancer in the U.S., Europe, and Japan. By
eliminating serious hypersensitivity infusion reactions, as well as
potentially reducing nerve damage and overcoming resistance to standard
taxanes, tesetaxel may offer important new treatment options for
patients with advanced cancer.”
"Having been associated with this drug since its original Phase 1 trial,
I am delighted to lead this key study that will enable the pivotal
trials to proceed,” said Dr. Anthony Tolcher, Director of Clinical
Research, South Texas Accelerated Research Therapeutics, San Antonio,
TX. "Completed Phase 2 studies of tesetaxel in advanced breast, colon
and stomach cancer have shown promising activity. We believe the
innovative development strategy created for tesetaxel may enable this
drug to become the first oral taxane to achieve regulatory approval.”
About Tesetaxel
Tesetaxel is a novel, orally absorbed, semi-synthetic taxane that is in
the same class of drugs as paclitaxel and docetaxel. However, both of
these agents suffer from serious safety issues, particularly
hypersensitivity reactions related to intravenous infusions that are
occasionally fatal and that require careful premedication and
observation. Other prominent side-effects of this drug class include
myelosuppression (low blood counts) and peripheral neuropathy (disabling
nerve damage).
With administration as an oral capsule, tesetaxel was developed with a
goal of maintaining the high antitumor activity of the taxane drug class
while eliminating infusion reactions, reducing neuropathy, and
increasing patient convenience. The oral route also enables the
development of novel schedules that may expand dosing options when
tesetaxel is used alone or in combination with other anticancer drugs,
including "all oral” chemotherapy programs. Preclinically, tesetaxel has
demonstrated substantially higher activity against cell lines that were
resistant to paclitaxel and docetaxel, since acquired resistance is not
mediated by the multidrug-resistant p-glycoprotein.
As a late Phase 2 oncology product, tesetaxel has demonstrated
anticancer activity in its initial clinical trials, and the drug has not
been associated with the severe infusion reactions that are linked with
other taxanes. Moreover, unlike other oral taxanes that are currently in
clinical development, nerve damage has not been a prominent side effect
of tesetaxel. Thus, the drug offers substantial opportunities to improve
patient convenience, safety, and anticancer activity. More than 250
patients worldwide have been treated with oral tesetaxel in Phase 1 and
Phase 2 clinical trials.
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: 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 necessary regulatory approval for
Genasense® from the U.S. Food and Drug
Administration ("FDA”);
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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
license and collaborative agreements, if any;
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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 2007 and its most recent quarterly report on Form 10-Q.