Genta Incorporated (OTCBB: GNTA) announced today that two new patents
related to the Company’s franchise in gallium-containing products have
issued in the United States. Applications similar to these patents are
pending worldwide, and several additional applications that address
other compositions and uses have been filed in the U.S. and other
territories. These patents and filings provide for claims of
compositions and uses of gallium compounds that can be taken by mouth
over extended periods for treatment of skeletal diseases as well as
other indications.
The two new patents, US 7,354,952B2 and US 7,456,215B2, provide for the
therapeutic use of gallium complexed with various agents that increase
the oral bioavailability of the active ingredient and yield superior
pharmacokinetics compared with the active ingredient used alone.
G4544 is a new, clinical-stage, tablet formulation that enables oral
absorption of the active ingredient contained in Ganite®
(gallium nitrate injection), a drug that is marketed by Genta and
approved in the U.S. for treatment of cancer-related hypercalcemia.
Genta is developing G4544 in collaboration with Emisphere Technologies,
Inc. (NASDAQ: EMIS). The initial clinical study -- a dose-ranging,
single-dose evaluation of G4544 in normal subjects – has been completed.
Genta is the IND Sponsor and is directing the clinical development
program.
"The active ingredient in G4544 has shown a consistently high level of
clinical activity across a range of skeletal diseases,” said Dr. Raymond
P. Warrell, Jr., Chairman and Chief Executive Officer of Genta. "We
believe that the emerging safety issues with long-term bisphosphonate
therapy can potentially be avoided with G4544. Our goal is to establish
bioequivalence to our IV drug in repeat-dose studies that may lead to
rapid approval in hypercalcemia. We also foresee the potential for
subsequent approvals in other diseases, such as bone metastases, Paget’s
disease, and osteoporosis.”
About G4544
G4544 was developed to enable extended administration of the active
ingredient in Ganite, which may greatly improve patient convenience and
avoid the current need for intravenous pumps or hospitalization. The
initial focus of clinical studies with G4544 will be to establish its
bioequivalence with the intravenous product, potentially enabling rapid
regulatory approval of the oral formulation via a 505(b)(2) application
in the U.S. Genta holds or has exclusively licensed the intellectual
property related to G4544.
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, which 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:
-
the Company’s ability to obtain necessary regulatory approvals for
Genasense® or its other product candidates;
-
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;
-
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;
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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.
