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Genta And Emisphere Technologies File IND With FDA For Oral Drug To Treat Bone Disease
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(R) (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, Chairman 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(R); Proctor and Gamble] and pamidronate [Aredia(R); 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(R) (oblimersen sodium)
Injection is the Company's lead compound from its oligonucleotide program.
The leading drug in Genta's small molecule program is Ganite(R) (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(R) and Genasense(R)
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(R) 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(R) 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 Statement for Genta
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(R) 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; 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.
Safe Harbor Statement for Emisphere Technologies
The statements in this release and oral statements made by
representatives of Emisphere relating to matters that are not historical
facts (including without limitation those regarding the timing or potential
outcomes of research collaborations or clinical trials, any market that
might develop for any of Emisphere's product candidates and the sufficiency
of Emisphere's cash and other capital resources) are forward-looking
statements that involve risks and uncertainties, including, but not limited
to, the likelihood that future research will prove successful, the
likelihood that any product in the research pipeline will receive
regulatory approval in the United States or abroad, the ability of
Emisphere and/or its partners to develop, manufacture and commercialize
products using Emisphere's drug delivery technology, Emisphere's ability to
fund such efforts with or without partners, and other risks and
uncertainties detailed in Emisphere's filings with the Securities and
Exchange Commission, including those factors discussed under the caption
"Risk Factors" in Emisphere's Annual Report on Form 10-K (file no. 1-10615)
filed on March 5, 2007.
Genta Inc.
http://www.genta.com
Genta de fiºiere ºi tehnologii de Emisphere ROM cu FDA pentru droguri oral pentru a trata boli osoase - Genta And Emisphere Technologies File IND With FDA For Oral Drug To Treat Bone Disease - articole medicale engleza - startsanatate