Galectin Therapeutics Secures U.S. Patent for its Proprietary Galectin Inhibitor GR-MD-02 in Fatty Liver Disease
February 26 2014 - 8:00AM
Galectin Therapeutics (Nasdaq:GALT), the leading developer of
therapeutics that target galectin proteins to treat fibrosis and
cancer, today announced that the U.S. Patent and Trademark Office
issued patent number 8,658,787 to the Company for its application
titled "Galacto-rhamnogalacturonate compositions for the treatment
of non-alcoholic steatohepatitis and non-alcoholic fatty liver
disease." The patent covers the Company's carbohydrate-based
galectin inhibitor compound GR-MD-02 for use in patients with fatty
liver disease with or without fibrosis or cirrhosis, providing
patent protection through 2031.
Fatty liver disease, which results in severe scarring of the
liver (cirrhosis), affects as many as 15 million Americans. There
are no currently approved pharmaceutical therapies. Intervention in
fatty liver disease patients with advanced fibrosis, with the
intent of reversing the fibrosis, is a potentially important
therapeutic approach in this unmet medical need.
"This patent, which provides patent protection through 2031,
represents a major milestone for the Company in that it covers the
use of GR-MD-02 in our primary development program to treat
patients with fatty liver disease with advanced fibrosis," said
Peter G. Traber, M.D., Chief Executive Officer, President and Chief
Medical Officer of Galectin Therapeutics. "Patent claims also cover
the use of GR-MD-02 in combination with multiple other agents that
may have potential activity in the disease that are under
investigation elsewhere, including bile acids as in development by
Intercept Pharmaceuticals."
The major claims are for methods of obtaining galectin inhibitor
compounds, obtaining a composition for parenteral or enteral
administration in an acceptable pharmaceutical carrier and
administering to a subject having at least one of the following:
fatty liver, non-alcoholic fatty liver disease, non-alcoholic
steatohepatitis, non-alcoholic hepatitis with liver fibrosis,
non-alcoholic steatohepatitis with cirrhosis, or non-alcoholic
steatohepatitis with cirrhosis and hepatocellular carcinoma. The
use covers reversing or slowing the progression of disease activity
or medical consequences of the disease. Applications are pending in
multiple countries to extend patent protection globally.
Galectin Therapeutics is currently conducting a Phase 1 clinical
trial to evaluate the safety, tolerability, pharmacokinetics 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. Last
month, the Company announced that patient enrollment in the first
cohort of the Phase 1 trial was complete and results are expected
to be announced around the end of the first quarter of 2014.
About Fatty Liver Disease with Advanced
Fibrosis
Non-alcoholic steatohepatitis (NASH), also known as fatty liver
disease, has become a common disease of the liver with the rise in
obesity rates, estimated to affect nine to 15 million people,
including children, in the U.S. Fatty liver disease is
characterized by the presence of fat in the liver along with
inflammation and damage in people who drink little or no alcohol.
Over time, patients with fatty liver disease can develop fibrosis,
or scarring of the liver, and it is estimated that as many as three
million individuals will develop cirrhosis, a severe liver disease
where liver transplantation is the only current treatment
available. Approximately 6,300 liver transplants are done on an
annual basis in the U.S. There are no drug therapies approved for
the treatment of liver 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 the hope that our development program for
GR-MD-02 will lead to the first therapy for the treatment of fatty
liver disease with fibrosis. Factors that could cause our actual
performance to differ materially from those discussed in the
forward-looking statements include, among others, that we may not
be successful in developing effective treatments and/or obtaining
the requisite approvals for the use of GR-MD-02 or any of our other
drugs in development. Our current clinical trial and any future
clinical studies may not 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 any of our development programs, we
may be unsuccessful in developing partnerships with other companies
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, 2012, 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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