Galectin Therapeutics Inc. Receives OK from FDA to Proceed with First Human
Clinical Trial for Treatment of Fatty Liver Disease with Advanced Fibrosis
NORCROSS, Ga., March 5, 2013
NORCROSS, Ga., March 5, 2013 /PRNewswire/ --Galectin Therapeutics
(NASDAQ:GALT), the leading developer of therapeutics that target galectin
proteins to treat fibrosis and cancer, announced today that following review
of its Investigational New Drug (IND) application, the US Food and Drug
Administration (FDA) notified the company that it may proceed with a Phase 1
clinical trial. The first-in-man Phase 1 clinical trial will support a
proposed indication of GR-MD-02 for treatment of non-alcoholic steatohepatitis
(NASH, or fatty liver disease) with advanced fibrosis.
"There are currently no approved medical treatments available for patients
with NASH and advanced fibrosis. This decision by the FDA is an important
milestone in our clinical development program to bring forward a treatment
option for these patients," said Dr. Peter G. Traber, President, Chief
Executive Officer, and Chief Medical Officer of Galectin Therapeutics Inc. "We
have recruited a world-class group of clinical investigators and engaged CTI
of Cincinnati Ohio, a full service Clinical Research Organization with
extensive experience in liver-related clinical trials, to run the operations
of the Phase 1 clinical trial."
The Phase 1 Clinical Trial is entitled, "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" and will be conducted in up to seven centers
in the United States. It is anticipated that the enrollment and infusion of
the first cohort will begin in May, 2013. Future communications will outline
study sites and investigators, notification of first infusion of patients, and
expected milestone timings for the study.
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.
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 our plans, expectations and goals regarding the
clinical trial and estimates regarding those impacted by NASH. Our plans,
expectations and goals regarding the clinical trial are subject to factors
beyond our control. Our clinical trial may not begin or 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. We may have
difficulty in enrolling candidates for testing 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, 2011, 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
SOURCE Galectin Therapeutics Inc.
Contact: Peter G. Traber, M.D., +1-678-620-3186, President, CEO & CMO,
Galectin Therapeutics Inc., firstname.lastname@example.org
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