Galectin Therapeutics perked
the interest of investors in January when the stock took an unusually big jump.
Obviously, the markets favored something in the company. Let’s look at what
that was and see if investors should take a look at the stock.
What Lifted the Stock Price?
Galectin Therapeutics is the
leading developer of therapeutics that targets galectin proteins to treat
fibrosis and cancer. The company received a “notice of allowance” from the US
Patent and Trademark Office for a patent application number. The patent covers
composition claim for uses of the company’s carbohydrate-based galectin
inhibitor compound GR-MD-02 for use in patients with liver fibrosis. It will be
used in combination with other potential therapeutic agents.
The patent will cover use
with agents directed at multiple targets currently in clinical development for
fibrosis disorders. Peter G Traber, president of Galectin Therapeutics, had
this to say:
“This patent provides
additional coverage in the U.S. for the use of GR-MD-02 in combination with
other potential anti-fibrotic agents in the treatment of liver fibrosis. In the
future, liver fibrosis could be treated with a combination of agents, and this
patent provides important intellectual property for this possibility.”
The company believes that
the development of its GR-MD-02 program could lead to the first therapy for
large unmet medical needs of liver fibrosis patients.
It is presently in a Phase 1
clinical trial evaluating the safety, tolerability and exploratory biomarkers
for efficacy for single and multiple doses of GR-MD-02. Patients with fatty
liver disease with advanced fibrosis will receive four weekly doses of GR-MD-02
treatment.
In the late winter of 2013,
the US Food and Drug Administration gave the company a fast track designation
for non-alcoholic steatohepatitis (NASH) with hepatic fibrosis, commonly known
as fatty liver disease with advanced fibrosis.
Pre-clinical Trials
In the company’s
pre-clinical trials, mice were treated with GM-CT-01 and GR-MD-02 at two
different points– early fibrosis and later on, more severe fibrosis. GR-MD-02
demonstrated that it proved NASH activity significantly. Not only was this good
news, but it also reduced fibrosis preventing/reducing the accumulation of
callagen in the liver. There was also a reduction in galectin-3 and other
inflammatory biomarkers.
Importance of GR-MD-02
Discovery
GR-MD-02 is a proprietary
molecule that binds to and inhibits galectin proteins, especially galectin-3.
Why is this so significant to GALT’s studies? It has been well documented that
elevated expression of Galectin-3 is closely associated with the relapse or the
aggressive nature of multiple forms of cancers in humans. Any proprietary
molecule that has an effect upon Galectin-3 is of interest to the cancer
community as a whole.
NASH & Liver Fibrosis
Industry
NASH (Non-alcoholic
steatohepatitis) is better known as fatty liver disease. One of the reasons
that the FDA gave this study by GALT a “Fast Track” designation is that NASH is
becoming a common disease of the liver because of the rise in obesity rates
here in the United States.
In the United States, it has
been estimated that 9 to 15 million people (including children) are affected.
Whereas liver disease is most notably caused by the long consumption of
alcohol, a fatty liver (the presence of fat in the liver along with
inflammation and damage) is in people who drink little or no alcohol.
Fatty liver disease can lead
to fibrosis or scarring of the liver. Of the estimated 9 to 15 million people
affected, 3 million will develop cirrhosis. The only cure for this is a liver
transplant. Presently, 6300 liver transplants are done annually in the United
States because there are no drug therapies approved for the treatment of liver
fibrosis.
Timing
The company is on a FDA Fast
Track Development Program for GR-MD-02. This status is usually given to agents
that show promise for treating serious and life-threatening medical conditions
where no other drug exists or works. In this designation, review of clinical
trials has a goal of taking place within 60 days. Nevertheless, is important to
understand that this could be a multi-year wait before the research for
GR-MD-02 is completed.
The company is in dialogue
with larger pharmaceutical companies to discuss a foundation for partnership
opportunities which would bring more working capital. The company is presently
trading at $12.50. With 20.7 million outstanding shares of common stock, the
company has a market value of approximately $229 million.
If the company continue on
its current pace, investors are likely looking at a long-term winner in
Galectin Therapeutics.
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