New Drug Targets Diseases Associated with Accelerated
Bone Loss
BERKELEY HEIGHTS, NJ AND TARRYTOWN, NY - August 1,
2007
- Genta Inc. (Nasdaq: GNTA) and Emisphere Technologies, Inc.
(Nasdaq: EMIS) jointly announced today the submission of an
Investigational New Drug Exemption (IND) to the Endocrinologic and
Metabolic Drugs Division of the U.S. Food and Drug Administration
(FDA) for a new drug known as G4544. Developed out of a joint
collaboration announced last year, G4544 is a new 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 that is resistant to hydration. The
IND proposes a Phase 1 clinical trial that will examine initial
safety and pharmacokinetics of G4544 in human subjects. Genta will
act as Sponsor of the IND and will direct the clinical development
program.
"The success of this project speaks to the expertise of
Emisphere in developing and deploying our patented technology to
address poorly absorbed compounds for broader patient use," said
Michael Novinski, President and Chief Executive Officer of
Emisphere Technologies. "We are excited by the prospect of helping
make treatments easier for a broad array of patients."
"Genta has pursued this project for a number of years, and we
are very pleased with the results of our collaboration with
Emisphere," said Dr. Raymond P. Warrell, Jr., Chairman and Chief
Executive Officer of Genta. "With this success, G4544 significantly
extends our intellectual property associated with the gallium
products franchise. Our initial focus will be to establish clinical
bioequivalence with our parenteral product. However, the active
ingredient in G4544 has already demonstrated proof-of-concept
activity in patients with multiple indications, including
non-Hodgkin's lymphoma, bone metastases, Paget's disease, and
osteoporosis. Going forward, Genta plans to manage the clinical
development programs in oncology, and we intend to seek a partner
for programs in metabolic bone disease."
Gallium-Containing Compounds
Gallium-containing compounds were originally developed by the
U.S. National Cancer Institute. In investigational studies, high
doses of gallium nitrate demonstrated consistent antitumor activity
in patients with non-Hodgkin's lymphoma. However, experimental work
by Genta personnel and others established that lower doses of
gallium 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, cancer, and Paget's disease. In some
diseases, the rate of loss is slow and subtle, while in others the
rate is rapid and acute. In osteoporosis, the most prevalent
bone-losing condition, the process of bone loss extends over many
years before the disease becomes evident. Conversely, in
cancer-related hypercalcemia, bone loss is so rapid that it
overwhelms the kidney's ability to eliminate calcium from the
blood, and this condition can quickly become lethal.
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.]). However, the approved dose-schedule for
Ganite calls for administration as a continuous intravenous
infusion for up to 5 days, which has generally limited its use to
patients with severe bisphosphonate-refractory disease.
Oral Gallium (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.
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. The
Company's research platform is anchored by two major programs that
center on oligonucleotides (RNA- and DNA- based medicines) and
small molecules. Genasense® (oblimersen sodium) Injection is the
Company's lead compound from its oligonucleotide 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. Genta is partnered
with IDIS (
http://www.idispharma.com/
) on a program whereby both 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/
.
About Emisphere Technologies
Emisphere Technologies, Inc. is a biopharmaceutical company that
focuses on a unique and improved delivery of therapeutic molecules
and pharmaceutical compounds using its eligen® technology. These
molecules and compounds could be currently available or are in
pre-clinical or clinical development. Such molecules or compounds
usually cannot be delivered by the oral route of administration or
the benefits of these compounds are limited due to poor
bioavailability, slow on-set of action or variable absorption. The
eligen® technology can be applied to the oral route of
administration as well other delivery pathways, such as buccal,
intra-colonic, pulmonary, intra-vaginal or transdermal. The Web
site is:
http://www.emisphere.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 2006 and its most recent
quarterly report on Form 10-Q.
CONTACT:
Tara Spiess
TS Communications Group LLC
info@genta.com
(908) 286-3980
