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Galectin Therapeutics
, the leading developer of therapeutics
that target galectin proteins to treat fibrosis and cancer, announced today
that it submitted an Investigational New Drug (IND) application to the US Food
and Drug Administration (FDA) on January 30, 2013. The IND application
supports a proposed indication of GR-MD-02 for treatment of non-alcoholic
steatohepatitis (NASH) with advanced fibrosis, or fatty liver disease.
“This IND submission is the first step in the clinical development program of
GR-MD-02 for the treatment of liver fibrosis,” said Dr. Peter G. Traber,
President, Chief Executive Officer, and Chief Medical Officer of Galectin
Therapeutics Inc. “We are leveraging our leadership in galectin science to
bring new treatment options for these severely underserved patients and
strongly believe that our novel approach of inhibiting galectin may be the key
to the prevention and reversal of liver fibrosis.”
The IND application includes twenty seven (27) individual studies that
characterize the pharmacology, pharmacokinetics, and toxicology of GR-MD-02 in
a number of animal species, including the effects in various animal models of
disease. Additionally, the application describes the manufacture of the drug
substance and drug product to be used in human clinical trials. This
information provides a description of how the drug works and why we believe it
is likely to be safe in humans and provides a description of its possible
mechanism of action in humans. The main purpose of the IND is to share with
the FDA the extensive non-clinical data that we believe predicts for an
acceptable safety profile when GR-MD-02 is first administered to humans in the
initial early-stage clinical studies. The FDA will review this application and
determine the acceptability of the data to predict the safety of GR-MD-02
before Galectin Therapeutics begins an initial human Phase 1 clinical trial.
It is possible that the FDA will require additional information. If the FDA
determines that the submitted package of data is acceptable, the Company plans
on proceeding with a Phase 1 clinical trial. Future communications will
outline study design and timing.
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