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Galectin Therapeutics Planning Clinical Trials for Early 2013 to Treat Fatty Liver Disease with Advanced Fibrosis After Recent



  Galectin Therapeutics Planning Clinical Trials for Early 2013 to Treat Fatty
  Liver Disease with Advanced Fibrosis After Recent FDA Meeting

Business Wire

NEWTON, Mass. -- August 07, 2012

Galectin Therapeutics (NASDAQ: GALT), the leading developer of therapeutics
that target galectin proteins to treat fibrosis and cancer, today announced
its clinical development program for the treatment of non-alcoholic
steatohepatitis (NASH), or fatty liver disease, with advanced fibrosis.
Galectin Therapeutics has selected GR-MD-02, a novel galectin inhibitor
discovered by the Company, as its lead candidate for NASH, which is expected
to enter clinical trials in early 2013. NASH represents a major unmet medical
need, affecting 9 to 15 million Americans, with the only treatment option
being liver transplantation.

“Patients who undergo liver transplantation for advanced fibrosis carry a high
possibility of disease recurrence because the underlying cause of the fibrosis
is not addressed,” said Peter G. Traber, MD, President, CEO and CMO of
Galectin Therapeutics. “GR-MD-02 has demonstrated the ability to not only
prevent, but reverse liver fibrosis in preclinical mouse models of NASH,
suggesting that this candidate could represent a disease-modifying treatment
option. We are currently conducting the final preclinical studies and have
trial design guidance from the Food and Drug Administration which will support
an IND submission by the end of 2012.”

GR-MD-02 is a carbohydrate-based candidate that inhibits galectins, key
modulators of liver fibrosis. In several preclinical studies, GR-MD-02 was
able to prevent and reverse liver fibrosis in mouse models of NASH. In
addition, GR-MD-02 was able to reverse the inflammatory component of NASH (fat
accumulation, liver cell degeneration and inflammatory cell infiltration). The
ability of GR-MD-02 to reduce existing fibrosis is further supported by
studies in toxin-induced fibrosis. Toxicology, pharmacology and manufacturing
studies are currently being conducted to support submission of an IND
application to the FDA by the end of 2012. A Phase 1 clinical trial in
patients with NASH with advanced fibrosis is anticipated to begin in the first
quarter of 2013.

About NASH

NASH is a common disease of the liver, affecting 9 to 15 million people in the
United States and 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, that
can lead to cirrhosis, a severe liver disease where transplantation is the
only current treatment available. Galectin Therapeutics is developing drug
candidates as an alternative to transplantation and lead candidates have
reversed fibrosis in preclinical disease models.

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. Factors that could
cause our actual performance to differ materially from those discussed in the
forward-looking statements include, among others: incurrence of operating
losses since our inception, uncertainty as to adequate financing of our
operations, extensive and costly regulatory oversight that could restrict or
prevent product commercialization, inability to achieve commercial product
acceptance, inability to protect our intellectual property, dependence on
strategic partnerships, product competition, and others stated in risk factors
contained in our SEC filings. We cannot assure that we have identified all
risks or that others may emerge which we do not anticipate. 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.
Maureen Foley, 617-559-0033
Chief Operating Officer
foley@galectintherapeutics.com
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