Galectin Therapeutics to Announce Results From First Cohort of Phase 1 Clinical Trial in Fatty Liver Disease
March 25 2014 - 8:00AM
Galectin Therapeutics (Nasdaq:GALT), the leading developer of
therapeutics that target galectin proteins to treat fibrosis and
cancer, announced that on Monday, March 31, 2014, the Company will
report results from the first cohort of its Phase 1 clinical trial
examining GR-MD-02 in fatty liver disease (NASH) with advanced
fibrosis. The first-in-man study, which enrolled eight patients in
the first cohort, is evaluating the safety, tolerability, and
exploratory biomarkers for efficacy for single and multiple doses
of galectin inhibiting drug GR-MD-02 when administered to patients
with fatty liver disease with advanced fibrosis.
Peter G. Traber, M.D., Chief Executive Officer, President and
Chief Medical Officer of Galectin Therapeutics, will lead a webcast
and conference call on April 1, 2014 at 8:30 a.m. Eastern Daylight
Time to review the findings. As time permits, a question and answer
session will immediately follow Dr. Traber's presentation.
A link to the webcast and conference call details will be posted
on the Galectin Therapeutics website at
www.galectintherapeutics.com. Dr. Traber's presentation will also
be posted on the Galectin Therapeutics website prior to the April 1
webcast and conference call.
The Phase 1 multi-center, partially-blinded clinical trial is
being conducted in a total of 24 patients who receive four weekly
doses of GR-MD-02. Each of the three cohorts consists of eight
patients, six randomized to receive active drug and two randomized
to receive placebo. Eight U.S. clinical sites with extensive
experience in clinical trials in liver disease are now active to
ensure rapid enrollment of the second cohort. Trial design details
can be found at
http://clinicaltrials.gov/ct2/show/NCT01899859?term=gt-020&rank=1.
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.
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.
CONTACT: Galectin Therapeutics Inc.
Peter G. Traber, MD, 678-620-3186
President, CEO, & CMO
ir@galectintherapeutics.com
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