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 (NYSEARCA:NASH) with hepatic fibrosis, commonly known as fatty liver disease with advanced fibrosis.
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.
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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