Galectin Therapeutics, Inc.
) recently raised $3 million through the exercise of 710,834
warrants, slated to expire on Aug 25, 2013.
The funds are in addition to the $3 million raised through the
recent private placement of common stock issuance by
Galectin intends to use the funds to speed up the process of
starting a phase II study on GR-MD-02. GR-MD-02 is currently in
phase I development for the treatment of nonalcoholic
steatohepatitis (NASH) with advanced fibrosis.
The company had submitted an Investigational New Drug (IND) to
the U.S. Food and Drug Administration (FDA) in Jan 2013, and
received approval for starting a phase I study in Mar 2013.
The company signed an agreement with Clinical Trial Services,
Inc. in Feb 2013, to study the safety and efficacy of GR-MD-02 in
humans in a phase I study. Under the terms of the agreement,
Clinical Trial Services will be responsible for the review and
supply notices regarding IND safety reports, selection of
investigators and monitoring the study, supplying information to
the investigators regarding new observations, and other services
for helping Galectin in conducting the study.
Galectin started enrolling patients in the phase I study on
GR-MD-02 in Jul 2013. The company expects to report top-line
results from the first cohort of the study later this year/early
next year. Data from the remaining cohorts should be out in
mid-2014. The company might start a phase II study in the third
quarter of 2014 based on phase I study results and expects phase
II study data by late 2015 or early 2016 depending on the design
of the study.
Furthermore, Galectin received Fast Track Designation from the
FDA for the development of GR-MD-02 in Aug 2013, for the
treatment of NASH.
We note that Galectin also has an oncology candidate,
GM-CT-01, in its portfolio. It is currently in phase I/II study
in Europe for treating patients with advanced melanoma (skin
Currently, Galectin carries a Zacks Rank #3 (Hold). Companies
that currently look well-positioned include
Gilead Sciences Inc.
) with a Zacks Rank #1 (Strong Buy) and
) with a Zacks Rank #2 (Buy).
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