Galectin Therapeutics Announces First Patient Dosed in Second Cohort of Phase 1 Trial of GR-MD-02 for NASH With Advanced Fibr...
April 17 2014 - 10:19AM
Galectin Therapeutics (Nasdaq:GALT), the leading developer of
therapeutics that target galectin proteins to treat fibrosis and
cancer, announced today that the first patient in cohort 2 of its
Phase 1 clinical trial of GR-MD-02 in patients with NASH with
advanced fibrosis has been successfully dosed with 4 mg/kg, which
is double the dose given in cohort 1. Cohort 2, as with all phases
of the clinical trial, was initiated in full compliance with the
rules, regulations, and specific conditions set forth by the U.S.
Food and Drug Administration (FDA) for this Phase 1 clinical trial.
The second cohort follows highly successful results from the first
cohort showing that 2 mg/kg was safe and very well tolerated, and
that GR-MD-02 treatment resulted in significant improvement in
multiple biomarkers of fibrosis and liver inflammation in patients
with NASH with advanced fibrosis (see full results:
http://galectintherapeutics.com/wp-content/uploads/2014/03/20140401GT020FirstCohortFINAL.pdf).
The remaining patients in cohort 2 are expected to be enrolled over
the next few weeks and we anticipate reporting the results of
cohort 2 around the end of July.
"We were extremely pleased with the results of the first cohort,
which demonstrated significant biomarker effects on fibrosis and
inflammation in all the patients treated with GR-MD-02, coupled
with good safety and tolerability," said Dr. Peter G. Traber,
President, Chief Executive Officer, and Chief Medical Officer of
Galectin Therapeutics Inc. "These positive results have propelled
the enrollment of the second cohort with strong participation
across our clinical trial sites. We anticipate the cohort 2 results
will further support the use of GR-MD-02 in patients with NASH and
advanced fibrosis, with the goal of reversing fibrosis and
preventing complications of cirrhosis and liver
transplantation."
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
http://clinicaltrials.gov/ct2/show/NCT01899859?term=gt-020&rank=1.
In 2013, Galectin Therapeutics received Fast Track designation from
the FDA for this clinical development program. 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.
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," "anticipated," "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 clinical trial, including
the expected timing of results for the second cohort, and potential
benefits and therapeutic effects of GR-MD-02. 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. We may have difficulty enrolling new patients, which could
impact timing and costs. Results from the first cohort of Phase 1
are not necessarily indicative of future results in the clinical
trial. 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, 2013,
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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