Galectin Therapeutics Receives FDA Fast Track Designation for GR-MD-02 for Fatty Liver Disease With Advanced Fibrosis

Galectin Therapeutics Receives FDA Fast Track Designation for GR-MD-02 for
Fatty Liver Disease With Advanced Fibrosis

NORCROSS, Ga., Aug. 12, 2013 (GLOBE NEWSWIRE) -- Galectin Therapeutics
(Nasdaq:GALT), the leading developer of therapeutics that target galectin
proteins to treat fibrosis and cancer, today announced that the U.S. Food and
Drug Administration (FDA) has granted GR-MD-O2
(galactoarabino-rhamnogalacturonate) Fast Track designation for non-alcoholic
steatohepatitis (NASH) with hepatic fibrosis, commonly known as fatty liver
disease with advanced fibrosis.

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
study will enroll eight patients in each dose escalation cohort and there will
be at least three cohorts and potentially up to five cohorts, with a maximum
of 40 patients at six clinical sites in the US, which each have extensive
experience in clinical trials in liver disease. More information on the
first-in-man Phase 1 clinical study of GR-MD-02 is available at

"Our preclinical data has shown that GR-MD-02 has robust treatment effects in
reversing fibrosis and cirrhosis. Fast Track designation enables us to
expedite the compound's development and review process, with the ultimate goal
of bringing a first-in-class treatment to the millions of Americans suffering
from fatty liver disease with advanced fibrosis," said Dr. Peter G. Traber,
President, Chief Executive Officer, and Chief Medical Officer of Galectin
Therapeutics Inc. "We are very pleased that the FDA sees the clinical value of
GR-MD-02 and seriousness of fatty liver disease, and we look forward to
working closely with the FDA throughout this process."

The FDA's Fast Track program is designed to expedite the review of new drugs
that are intended to treat serious or life-threatening conditions and
demonstrate the potential to address unmet medical needs.

About GR-MD-02

GR-MD-02 is a complex carbohydrate drug that targets galectin-3, a critical
protein in the pathogenesis of fatty liver disease and fibrosis. Galectin
proteins play a major role in diseases that involve scaring of organs such as
cancer, and inflammatory and fibrotic disorders. The drug binds to galectin
proteins and disrupts their function. Preclinical data has shown that GR-MD-02
has robust treatment effects in reversing fibrosis and cirrhosis in kidney,
lung, and liver.

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 US. 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 US. 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

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 plans, expectations and goals, expectations and goals
regarding the clinical trial, our FAST TRACK submission and the potential
benefits of a FAST TRACK designation, potential therapeutic uses and benefits
of our galectin inhibitors and further related studies and potential
partnerships. Factors that could cause our actual performance to differ
materially from those discussed in the forward-looking statements include,
among others, that the receipt of a FAST TRACK designation from FDA is no
guarantee that we avoid delays in the development of our drug product and
provide no assurance of FDA approval of our drug development plans and of the
grant of marketing approval for our drug product.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 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

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