Galectin Therapeutics Announces First Patient Dosed in Phase 1 Trial of
GR-MD-02, a Potential First-in-Class Treatment for Fatty Liver Disease with
NORCROSS, Ga., July 24, 2013
NORCROSS, Ga., July 24, 2013 /PRNewswire-USNewswire/ -- Galectin Therapeutics
(NASDAQ:GALT), the leading developer of therapeutics that target galectin
proteins to treat fibrosis and cancer, announced today that the first patient
has been successfully dosed in a Phase 1 clinical trial of GR-MD-02. The
first-in-man study will evaluate the safety, tolerability, and exploratory
biomarkers for efficacy for single and multiple doses of GR-MD-02 when
administered to patients with fatty liver disease with advanced fibrosis.
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.
"The successful first patient dosing in the clinical trial of GR-MD-02 is a
critical milestone in Galectin's development program. There are currently no
treatments for fatty liver disease with advanced fibrosis; this milestone
takes us one step closer to bringing a first-in-class treatment to the
millions of Americans suffering from this silent epidemic," said Dr. Peter G.
Traber, President, Chief Executive Officer, and Chief Medical Officer of
Galectin Therapeutics Inc. "We anticipate that enrollment of the first cohort
of eight patients in the Phase 1 trial will be complete by late summer with
initial safety and tolerability results available following the 70 day study
period and analysis of the data."
The Phase 1 multi-center, partially-blinded clinical trial will be conducted
in 24 patients with fatty liver disease and advanced fibrosis who will receive
four weekly doses of GR-MD-02. The study, which includes a dose escalation
design, will be conducted at six US centers with extensive experience in
clinical trials in liver disease. This first patient dosing took place at
Indiana University under the direction of the Principal Investigator Dr. Naga
Chalasani, a world-renowned expert in NASH.
The trial is titled, "A Multi-Center, Partially Blinded, Maximum Tolerated
Multiple Dose Escalation, Phase 1 Clinical Trial to Evaluate the Safety of
GR-MD-02 in Subjects with Non-Alcoholic Steatohepatitis (NASH) with Advanced
Hepatic Fibrosis." Trial design details can be found at
An estimated 9 to 15 million Americans, including children, are affected by
fatty liver disease. Without an available therapeutic treatment, the only
alternative for patients with fatty liver disease is a transplant but there
are limited donors available and the procedure is costly.
Recently, Galectin submitted a Fast Track application to the FDA to help
expedite its clinical development program of GR-MD-02 in fatty liver disease
with advanced fibrosis. FDA grants Fast Track designation to help expedite
review and approval of drugs in development that treat serious or life
threatening diseases and fill an unmet medical need.
NASH has become a common disease of the liver with the rise in obesity rates,
affecting 9 to 15 million people, including children, in the United States.
NASH 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 NASH can develop fibrosis, or scarring of the liver, and it is
estimated that as many as 3,000,000 will develop cirrhosis, a severe liver
disease where transplantation is the only current treatment available.
Approximately 6,300 liver transplants are done on an annual basis in the
About Galectin Therapeutics Inc.
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. Follow us on Twitter @GalectinGALT.
Forward Looking Statements
This press release contains, in addition to historical information, statements
that look forward in time or that express management's beliefs, expectations
or hopes. Such statements are 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 risks and uncertainties that could cause
actual results to differ materially from those described in the statements.
These statements include those regarding our plans, expectations and goals
regarding the clinical trial, our Fast Track submission and the potential
benefits of a Fast Track designation, and our estimates regarding those
impacted by NASH. 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 the clinical
trial are subject to factors beyond our control. Our clinical trial may not
produce positive results in a timely fashion, if at all, and any necessary
changes during the course of the trial could prove time consuming and costly.
Also, receipt of a Fast Track designation from the FDA is beyond our control
and the FDA may not approve our application. In regard to our clinical trial,
we may have difficulty in enrolling candidates for testing, which would impact
our estimates regarding timing, and we may not be able to achieve the desired
results. Upon receipt of FDA approval, we may face competition with other
drugs and treatments that are currently approved or those that are currently
in development, which could have an adverse impact on our ability to achieve
revenues from this proposed indication. Plans regarding development, approval
and marketing of any of our drugs, including GR-MD-02, are subject to change
at any time based on the changing needs of our company as determined by
management and regulatory agencies. 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.
SOURCE Galectin Therapeutics
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