The U.S. Patent and Trademark Office (USPTO) recently issued a Notice of Allowance for the use of Galectin Therapeutics, Inc.’s (GALT) GR-MD-02.
The patent covers both composition and uses of carbohydrate-based galectin inhibitor GR-MD-02 for use in patients with liver fibrosis in combination with other potential therapeutic agents.
GR-MD-02 is currently in phase I development for the treatment of nonalcoholic steatohepatitis (NASH) with advanced fibrosis. Spread over a period of four weeks, the trial will evaluate single and multiple doses of GR-MD-02 for evaluating the safety, tolerability and exploratory biomarkers for efficacy.
Galectin Therapeutics has also obtained Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the development of GR-MD-02 in Aug 2013, for the treatment of NASH with advanced fibrosis.
Galectin Therapeutics started enrolling patients in the phase I study on GR-MD-02 in Jul 2013. The company expects to report top-line results in early 2014. Data from cohort 2 and cohort 3 should be out in mid-2014. The company might start a phase II study in late 2014 or early 2015 based on phase I study results and expects phase II top-line data in the first half of 2016 depending on the design of the study.
A phase I study is being designed for GR-MD-02 in combination with Bristol-Myers Squibb Co.’s (BMY) Yervoy for the treatment of immunotherapy for metastatic melanoma.
Currently, Galectin Therapeutics carries a Zacks Rank #4 (Sell). Some better-ranked stocks include Lannett Company, Inc. (LCI) and Forest Laboratories Inc. (FRX). Both these stocks carry a Zacks Rank #1 (Strong Buy).
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