BERKELEY HEIGHTS, NJ - April 28, 2009
- Genta Incorporated (OTCBB: GNTA.OB) announced today that the
European Patent Office intends to grant two key patents related to
the Company's intellectual property position on Genasense®
(oblimersen sodium) Injection. The Company has proceeded with
grant formalities and validation of the patents.
Corresponding patents and applications have issued or are pending
worldwide. Together, the patents will provide protection for
compositions, sequences, and pharmaceutical uses of Genasense and
related compounds that attack Bcl-2, the molecular target of
Genasense action.
"Regulation of Bcl-2 gene expression" (EP Publication No.
1584682(A1); Inventor: Reed) covers claims for various compositions
and sequence chemistries including Genasense, use of the sequences
in pharmaceutical applications such as gene regulation by antisense
and treatment of cancer, and combinations of such agents with
multiple other therapeutic drugs to enhance anticancer activity in
human subjects.
"Methods of treatment of a Bcl-2 disorder using Bcl-2 antisense
oligomers" (EP Publication No. 1313514(A2); Inventors: Warrell et
al.) claims compositions and uses of Bcl-2 antisense
oligonucleotides such as Genasense over various dosing ranges and
by multiple routes of administration that are known to be
clinically active in patients with cancer.
"Genta's patent estate related to Genasense is extensive,
we have detailed plans for securing rapid approval in Europe with
positive data this Fall," said Dr. Raymond P. Warrell, Jr., Genta's
Chief Executive Officer. "The majority of patients enrolled
into the AGENDA trial, a Phase 3 trial of Genasense in melanoma
that completed accrual earlier this month, originated from
Europe. The extended market protection offered by these
patents comes at an especially favorable time in the product's
lifecycle."
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® (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
