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Genta
to Support Initiation of New Clinical Trial using Ganite® as
Treatment for Life-Threatening Infections in Patients with Cystic
Fibrosis
BERKELEY HEIGHTS, NJ – December 2,
2009 – Genta Incorporated (OTCBB: GETA) announced that the Company will
supply Ganite® (gallium
nitrate injection) for a new clinical trial that will be initiated in patients
with cystic fibrosis (CF) who may develop serious infections.
Infection
is the most common cause of death in CF patients. Frequently, these
infections are due to bacteria known as Pseudomonas aeruginosa, and
patients are commonly treated with years of antibiotic therapy to control such
infections. However, prolonged antibiotic use has greatly increased
resistance due to genetic mutations. In addition, Pseudomonas has evolved
protective mechanisms known as “biofilms” that encase colonies of bacteria and
prevent antibiotics from reaching infection sites. Bacteria in
biofilms are far more resistant to being killed. Recent information
has suggested that gallium may be used as an anti-bacterial agent against Pseudomonas, in part due to
its ability to disrupt biofilms.
The
initial clinical trial using a gallium compound for this purpose will involve
patients with cystic fibrosis who will be treated at the University of
Washington in Seattle, WA and the University of Iowa, Iowa City,
IA. If initial results are promising, additional trials will be
conducted with additional medical centers and a larger number of
patients. Genta has provided cross-reference to its Investigational
New Drug (IND) exemption for Ganite®, and the
Company will supply the drug at no cost to patients in the trial. The
study is also supported by grants awarded by the Orphan Products Division of the
Food and Drug Administration (FDA) and by the Cystic Fibrosis
Foundation.
“Work
from our center has established that gallium can be used as a 'Trojan horse'
that interferes with how iron is used by Pseudomonas”, said Dr.
Christopher H. Goss, Associate Professor of Medicine at the University of
Washington, who is the Principal Investigator of the trial. “Our
preliminary data suggest that gallium exploits potentially vulnerable mechanisms
in Pseudomonas by
disrupting biofilms and killing antibiotic-resistant strains of
bacteria. This study is the first formal pharmacokinetic and safety
evaluation of gallium in patients with cystic fibrosis.”
“This
trial represents the rapid clinical translation of enormously promising
observations”, said Dr. Raymond P. Warrell, Jr., Genta’s Chief Executive
Officer. “Initial results from our first CF patient showed that
systemic treatment achieved target gallium levels in sputum, and that these
levels could be sustained for a prolonged duration. Pseudomonas infections in CF
are exceptionally difficult to eradicate. If initial results of the
IV drug in this trial are promising, future patients might also benefit from
extended therapy that could be afforded by one of our oral gallium
compounds.”
Further
background on this work from the Universities of Washington and Iowa can be
accessed here: http://www.jci.org/articles/view/30783/pdf.
About
Ganite®
Ganite® is
exclusively marketed by Genta and is approved in the U.S. for treatment of
cancer-related hypercalcemia that is resistant to hydration. The
potential use(s) described in the release are investigational and have not been
approved.
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. Genasense is being developed as an agent that may
enhance the effectiveness of current anticancer therapy. 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, which 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: 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:
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the Company’s ability to
obtain necessary regulatory approval for its product candidates from
regulatory agencies such as the U.S. Food and Drug Administration
(“FDA”);
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the safety and efficacy of the
Company’s products or product
candidates;
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the commencement and
completion of any clinical
trials;
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the Company’s assessment of
its clinical trials;
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the Company’s ability to
develop, manufacture, license, or sell its products or product
candidates;
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the Company’s ability to enter
into and successfully execute any license and collaborative
agreements;
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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,
the financial ability to sustain further followup in the AGENDA trial, or
the Company’s risk of
bankruptcy;
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the adequacy of the Company’s
patents and proprietary
rights;
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the impact of litigation that
has been brought against the Company;
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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.
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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