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March 5, 2013
09:03 EDTGALTGalectin Therapeutics receives FDA approval to proceed with human clinical trial
Galectin Therapeutics announced that following review of its Investigational New Drug application, the 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 with advanced fibrosis.
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April 17, 2014
10:21 EDTGALTGalectin Therapeutics announces first patient dosed in GR-MD-02 trial
Galectin Therapeutics announced 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 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. 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.
April 7, 2014
11:15 EDTGALT Options with decreasing implied volatility: MNKD GALT DLLR APOL
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