Genta Receives Notice of Allowances for European Patents
Related to Composition and Processes for Tesetaxel, a Leading
Oral Taxane
BERKELEY HEIGHTS, NJ - June 10, 2008 -
Genta Incorporated (OTCBB: GNTA) announced that the Company
has received notice of allowances for two major patents from the
European Patent Office for its pipeline product, tesetaxel, a
leading oral taxane. The patents relate to composition of
matter for the tesetaxel drug substance and to processes for its
synthesis. The Company plans to broadly secure validation of
these patents throughout the major countries in Europe. The
European patents complement existing patents that have already
issued in the United States. Genta holds worldwide exclusive
licenses to these patents.
In a related matter, the Company announced that it had submitted
a "complete response" to the Food and Drug Administration (FDA) and
had requested that the clinical hold that had been placed on
tesetaxel be lifted in order to allow resumption of clinical
trials. Among other items, the submission included requested
toxicokinetic analyses and a proposal for a new clinical
study. Initial action by FDA on this submission is expected
in the second quarter of 2008.
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 prototype 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
to maintain the high antitumor activity of the taxane drug class
while eliminating infusion reactions, reducing neuropathy, and
increasing patient convenience. The oral route also enables
development of novel schedules that may expand dosing options when
tesetaxel is used alone or in combination with other anticancer
drugs. 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 I and Phase 2 clinical trials. The major
side-effect of tesetaxel in clinical trials has been
myelosuppression, chiefly neutropenia. Due to the occurrence
of severe neutropenia that led to fatal outcomes in several
patients with advanced cancer, the drug was placed on clinical hold
by the U.S. Food and Drug Administration (FDA). Resumption of
clinical trials is subject to the lifting of this clinical
hold.About Genta.
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:
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. Forward-looking
statements include, without limitation, statements about:
- the Company's ability to obtain necessary regulatory approval
for Genasense® from the U.S. Food and Drug Administration ("FDA")
or European Medicines Agency ("EMEA");
- 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
license and collaborative agreements, if any;
- the adequacy of the Company's capital resources and cash flow
projections, and the Company's ability to obtain sufficient
financing to maintain the Company's planned operations;
- the adequacy of the Company's patents and proprietary
rights;
- the impact of litigation that has been brought against the
Company and its officers and directors and any proposed
settlement of such litigation;
- the Company's ability to retain compliance with the NASDAQ's
listing qualifications; 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.
The Company does not undertake to update any forward-looking
statements. 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.
SOURCE: Genta Incorporated
CONTACT:
Genta Investor Relations
908-286-3980
info@genta.com
