BERKELEY HEIGHTS, NJ - June 2, 2008
- Genta Incorporated (OTCBB: GNTA) announced the release of
final results from the Company's Phase 1 clinical trial of G4544, a
proprietary small molecule that is intended as a treatment for
diseases associated with accelerated bone loss. Results
showed that the drug was very well-tolerated, and that blood levels
were achieved in a range that is known to be clinically
bioactive. The data were featured in a poster session at the
annual meeting of the American Society of Clinical Oncology (ASCO)
in Chicago on Saturday May 31, 2008.
G4544 is a new tablet formulation using delivery technology
developed by Emisphere Technologies, Inc. that enables oral
absorption of the active ingredient contained in Ganite® (gallium
nitrate injection). Ganite® is marketed by Genta and is
approved in the U.S. for treatment of cancer-related hypercalcemia
that is resistant to hydration. Low doses of the active
ingredient in Ganite administered by intravenous (IV) or
subcutaneous injections have shown clinical activity in a range of
skeletal diseases, including hypercalcemia, bone metastasis
(myeloma and breast cancer), Paget's disease, and osteoporosis.
The Phase 1 clinical study tested escalating single doses of
G4544 in 30 normal volunteers. The endpoints of the study
were to determine safety and to assess pharmacokinetics and oral
bioavailability. The drug was tested over a range of doses
from 30 to 150 mg. No adverse effects attributable to G4544
were observed. The mean peak plasma concentration at the
highest dose was approximately 0.4 ?جŬ?g/ml with a mean area
under the plasma x concentration curve of approximately 20
?جŬ?g/ml*hr.
"G4544 offers both ease of administration and patient
convenience that could considerably expand the usefulness of this
highly active compound," said Dr. Raymond P. Warrell, Jr., Chairman
and Chief Executive Officer of Genta. "We concluded our
initial conference with FDA's Endocrinology and Metabolism Division
to clarify next steps. Completion of abbreviated toxicology
work should enable multi-dose studies to proceed that are needed to
secure regulatory approval. The published clinical activity
using low doses should be highly informative in guiding further
clinical development."
About G4544
Experimental work by Genta personnel and others first established
that low doses of the active ingredient in Ganite® directly
inhibited calcium release from bone, principally by decreasing bone
resorption and possibly by also stimulating bone formation.
Many diseases are associated with accelerated bone loss,
including osteoporosis, bone metastases in cancer, Paget's disease,
and hypercalcemia - a disease in which the rate of bone loss may
become acutely life-threatening. In patients with cancer-related
hypercalcemia who were resistant to hydration, randomized
double-blind trials have been conducted with Ganite compared with
calcitonin and with two bisphosphonates (etidronate [Didronel®;
Proctor and Gamble] and pamidronate [Aredia®; Novartis, Inc.]).
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 extended IV infusion or
hospitalization. The initial focus of clinical studies with
G4544 will be to evaluate bioequivalence with the IV product,
potentially enabling rapid regulatory approval. 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, 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
