Attached files
file | filename |
---|---|
8-K - GENTA INC DE/ | v181630_8k.htm |
200 Connell Drive
Berkeley
Heights, NJ 07922
Genta
Presents Initial Clinical Data on Use of Gallium Compounds as Treatment for
Serious Infections
--
AACR presentation suggests potential applications in cystic fibrosis, cancer,
and sepsis
--
Clinical study in cystic fibrosis to start in May 2010
BERKELEY HEIGHTS, NJ – April 20,
2010 – Genta Incorporated (OTCBB: GETA.OB) today announced the
presentation of initial results from the first human use of a gallium-containing
compound to treat serious infection. In a patient with cystic
fibrosis and a highly resistant lung infection, who has been treated over a
2-year period, high concentrations of gallium were achieved in
sputum. Moreover, sputum concentrations were higher than simultaneous
concentrations in blood and continued to rise even after treatment had been
stopped. Measured concentrations in sputum equaled or exceeded
concentrations that have been reported lethal to bacteria in laboratory
tests. The data were presented at the annual meeting of the American
Association of Cancer Research in Washington, D.C.
Gallium
is known to interfere with certain iron-dependent metabolic processes, which can
be lethal to single-cell organisms such as bacteria, mycobacteria (e.g.,
tuberculosis), protozoa (e.g., malaria), and fungi. Infection is the
most common cause of death in patients with cystic fibrosis, which are
frequently caused by bacteria known as Pseudomonas aeruginosa that
have become highly resistant after years of antibiotic
therapy. Recent laboratory data have suggested that gallium may kill
these bacteria and also augment the activity of standard
antibiotics.
In a
preliminary clinical test, a patient with cystic fibrosis and extensive lung
infection due to highly resistant Pseudomonas was treated with
intermittent intravenous (IV) infusions of gallium nitrate (administered as
Ganite® [gallium
nitrate injection]) over a 2-year period. Blood and sputum
concentrations were measured during and after two of these
infusions.
Sputum
gallium concentrations from infected lungs were consistently higher than levels
simultaneously obtained in plasma. In the 2 cycles of treatment with
pharmacologic monitoring, these concentrations substantially exceeded levels
that laboratory tests had previously shown were lethal to resistant Pseudomonas. Moreover,
gallium concentrations in sputum continued to rise even after IV therapy was
discontinued. Extended treatment with IV gallium nitrate was
well-tolerated despite the presence of extensive lung disease and substantial
compromise of pulmonary function. Previously deteriorating clinical
status due to pulmonary failure was stable over the 2-year period.
“These
data show that gallium is preferentially concentrated in sputum of infected
lungs”, said Dr. Raymond P. Warrell, Jr., Genta’s Chief Executive
Officer. “High levels were achieved and sustained during short
courses of treatment -- an especially promising result that should obviate any
need to consider direct inhalation. A new clinical trial to formally
evaluate IV gallium nitrate in patients with cystic fibrosis will begin next
month. These preliminary data also suggest that our oral
gallium-containing compound may be useful for this purpose as chronic
therapy.”
The
potential use(s) described in this release are investigational and have not been
approved. Genta is exclusively marketing an IV form of gallium
nitrate (Ganite® [gallium
nitrate injection]), which is indicated for treatment of symptomatic patients
with cancer-related hypercalcemia that is resistant to hydration. The
Company has also developed proprietary oral formulations of the active
ingredient in Ganite® that are
being evaluated as potential treatments for diseases associated with accelerated
bone loss.
The new
clinical trial discussed in this release is expected to begin in May 2010 and
will enroll patients with cystic fibrosis who will be treated at the University
of Washington, Seattle, WA, and the University of Iowa, Iowa City,
IA. If initial results are promising, additional trials may be
conducted at other medical centers in a larger number of
patients. For this trial, 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 supported by grants from the Orphan Products Division of the Food and
Drug Administration (FDA) and the Cystic Fibrosis Foundation. Further
background on this work can be accessed at: 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
symptomatic patients with cancer-related hypercalcemia that is resistant to
hydration. The potential use(s) described in this 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 anticancer
therapy. The Company is currently collecting long-term followup data
on durable response and overall survival from the recently completed randomized
Phase 3 study of Genasense® in patients with advanced melanoma (the AGENDA
trial). 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. Genta has initiated a broad clinical
program to evaluate the safety and efficacy of tesetaxel in patients with solid
tumors. In the U.S., Genta is exclusively marketing Ganite® (gallium nitrate
injection), which is indicated for treatment of symptomatic patients with
cancer-related hypercalcemia that is resistant to hydration. The
Company has developed proprietary oral formulations of the active ingredient in
Ganite® that are
being evaluated as potential treatments for diseases associated with accelerated
bone loss. 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:
·
|
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 and the European Medicines
Agency;
|
·
|
the
safety and efficacy of the Company’s products or product
candidates;
|
·
|
the
commencement and completion of any clinical
trials;
|
·
|
the
Company’s assessment of its clinical
trials;
|
·
|
the
Company’s ability to develop, manufacture, license, or sell its products
or product candidates;
|
·
|
the
Company’s ability to enter into and successfully execute any license and
collaborative agreements;
|
·
|
the
adequacy of the Company’s capital resources and cash flow projections, or
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
|
·
|
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.
|
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 2009 and its most recent
quarterly report on Form 10-Q.
SOURCE:
Genta Incorporated
CONTACT:
Genta
Investor Relations
info@genta.com