Galectin Therapeutics Receives U.S. Patent for GR-MD-02 in Diabetic Nephropathy, a Progressive Kidney Disease
May 28 2014 - 8:00AM
Galectin Therapeutics Inc. (Nasdaq:GALT), the
leading developer of therapeutics that target galectin proteins to
treat fibrosis and cancer, today announced that it has received a
notice of allowance from the U.S. Patent and Trademark Office for
patent application number 13/998,197 titled "Galactose-Pronged
Carbohydrate Compounds for the Treatment of Diabetic Nephropathy
and Associated Disorders." The patent covers both composition claim
for and uses of the Company's carbohydrate-based galectin inhibitor
compound GR-MD-02 in patients with diabetic nephropathy, a type of
progressive kidney disease that occurs in individuals with
diabetes. Diabetic nephropathy is the major cause for chronic renal
failure in the United States.
"This patent provides coverage for additional use
of GR-MD-02, our proprietary galectin inhibitor, which has shown in
studies to have a powerful therapeutic effect on fibrosis and
inflammation," said Dr. Peter G. Traber, President, Chief Executive
Officer, and Chief Medical Officer of Galectin Therapeutics Inc.
"Evidence suggests that inflammatory mechanisms play a significant
role in the development and progression of diabetic nephropathy.
Additionally, in pre-clinical studies, we found that treatment of
diabetic mice with GR-MD-02 reversed diabetic nephropathy. This
patent, which also covers other glomerulopathies that cause renal
failure, secures the path forward for the Company's exploration of
the effects of galectin inhibition in diabetic nephropathy, which
affects approximately 40 percent of type 1 and type 2 diabetic
patients."
Galectin Therapeutics is currently conducting a Phase 1 clinical
trial to evaluate the safety, tolerability and exploratory
biomarkers for efficacy for single and multiple doses of GR-MD-02
over four weekly doses of GR-MD-02 treatment in patients with fatty
liver disease with advanced fibrosis. The results from first cohort
showed that the 2 mg/kg dose was safe and very well tolerated, and
that GR-MD-02 treatment resulted in significant improvement in
multiple biomarkers of liver fibrosis and inflammation in patients
with NASH with advanced fibrosis.
About Galectin Therapeutics
Galectin Therapeutics (Nasdaq:GALT) is developing
promising carbohydrate-based therapies for the treatment of
fibrotic liver disease and cancer based on the Company's unique
understanding of galectin proteins, key mediators of biologic
function. We are leveraging extensive scientific and development
expertise as well as established relationships with external
sources to achieve cost effective and efficient development. We are
pursuing a clear development pathway to clinical enhancement and
commercialization for our lead compounds in liver fibrosis and
cancer. Additional information is available at
www.galectintherapeutics.com.
Forward Looking Statements
This press release contains, in addition to
historical information, forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
These statements relate to future events or future financial
performance, and use words such as "may," "estimate," "could,"
"expect" and others. They are based on our current expectations and
are subject to factors and uncertainties which could cause actual
results to differ materially from those described in the
statements. These statements include those regarding preclinical
data and the potential role for GR-MD-02 and GM-CT-01 in the
treatment of diabetic nephropathy, liver fibrosis and cirrhosis and
cancer in humans. Factors that could cause our actual performance
to differ materially from those discussed in the forward-looking
statements include, among others, that our plans, expectations and
goals regarding any preclinical data and potential therapeutic uses
and benefits of our drugs and any future pre-clinical or clinical
studies are subject to factors beyond our control. Future clinical
studies may not begin or produce positive results in a timely
fashion, if at all, and could prove time consuming and costly.
Plans regarding development, approval and marketing of any of our
drugs are subject to change at any time based on the changing needs
of our company as determined by management and regulatory agencies.
Regardless of the results of current or future studies, we may be
unsuccessful in developing partnerships with other companies or
obtaining capital that would allow us to further develop and/or
fund any studies or trials. To date, we have incurred operating
losses since our inception, and our ability to successfully develop
and market drugs may be impacted by our ability to manage costs and
finance our continuing operations. For a discussion of additional
factors impacting our business, see our Annual Report on Form 10-K
for the year ended December 31, 2013, and our subsequent filings
with the SEC. You should not place undue reliance on
forward-looking statements. Although subsequent events may cause
our views to change, we disclaim any obligation to update
forward-looking statements.
CONTACT: Galectin Therapeutics Inc.
Peter G. Traber, MD, 678-620-3186
President, CEO, & CMO
ir@galectintherapeutics.com
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