While modern medicine has progressed leaps and bounds in developing effective treatments for just about any form of human ailments, one area that still confounds scientists and doctors is the liver. Arguably the most complex and vital organ in the human body, with the exception of the brain, the liver is responsible for many functions that are essential to life. Yet, aside from transplant surgery, there is still no viable long-term solution to treat liver damage and failure caused by diseases such as various forms of hepatitis, results of alcohol abuse, and fatty liver disease. These conditions lead to liver fibrosis, which is the excessive formation of scar tissue on the organ, to the point that it causes dysfunction and medical complications.
"When somebody has scarring of the liver there’s a very nihilistic view in medicine and healthcare because the only thing you can do is replace the liver with a transplant," says Peter Traber, CEO and Chief Medical Officer of Galectin Therapeutics, Inc. (GALT). "When you have to transplant an organ, you’re really admitting that the disease has defeated us and all we can do is take the liver from someone else who has died and put it in the patient. That’s a very bad situation."
As the CEO of Galectin Therapeutics, Traber is leading his company in an effort to revolutionize the way the medical industry deals with liver disease, as well as a wide variety of others including various forms of cancer. By focusing on a class of molecules known as galectin proteins, the company is paving the way in developing new treatments for major diseases.
"One of the most important aspects of galectin proteins is that they’re becoming much, much better recognized as a class of molecules that are important in a wide variety of diseases, including cancer, inflammatory disorders, fibrosis, and fibrotic disorders," Traber says. "It is becoming increasingly recognized that galectins are really important targets for drug development, and Galectin Therapeutics is [strike really] the leader in this area."
Galectins as the Next Big Thing
Galectin proteins are increasingly becoming a major point of interest in medical research. There are 15 subtypes of the protein that have common characteristics of carbohydrate recognition, and can promote cell growth as well as play a vital role in the body's immune system.
These characteristics make galectin proteins an excellent target for drug development. Traber says most major markets in the drug industry is built around a target of a specific cellular or genetic factor associated with a disease. Given that the study of galectins is still relatively new territory, albeit gaining traction at a very rapid pace, Traber believes Galectin Therapeutics is, in a sense, paving a new way in the industry.
"The drug industry goes by targets," he says. "For instance, when you look at cholesterol treatments. A certain enzyme target became the most important target in the whole drug industry and the whole drug industry was built up around that. The same thing happened in ulcer drugs, and any kind of drug you can think of where there is a very large market and revolves around an important target. We feel, and many others agree, that galectin proteins are really critical targets that are going to be focused on for a lot of diseases."
While the potential of diseases that can be treated through galectin-targeted drugs ranges on a wide scale, the company is currently focused on two specific areas: liver fibrosis and cancer, particularly melanoma.
Galectin's Liver Fibrosis Treatment
According to the National Institute of Health, between 9 million to 15 million suffer from fatty liver disease in the U.S., which can lead to fibrosis and severe scarring of the vital organ. In addition, as many as 50,000 Americans die of cirrhosis every year. The only treatment for fibrosis of the liver is a viable transplant, and according to the American Liver Foundation, only about 6,000 transplants are done in the U.S. each year. The problem is over 16,000 people are on the waiting list.
Currently, Galectin Therapeutics is developing a treatment that could potentially reverse the effects of fibrosis. The drug would work by using carbohydrate molecules that bind to the galectin proteins, inhibiting the development of scar tissue and fibrosis and possibly reversing existing fibrosis. Currently in preclinical trials, the drug has yielded positive results in animal models.
"We are currently involved in preclinical toxicology and other work, and plan on submitting an Investigational New Drug application to the FDA in November of this year for liver disease," Traber says. "Therefore we hope to initiate phase I clinical trials for in humans in the first half of 2013, and hope to complete the phase I trial by the second half of 2013, and start phase 2 clinical trials by the end of 2013, with top line results by the end of 2014."
If the company is successful in executing on its milestones, it could essentially tap into an unchallenged market for a drug in high demand. Given that liver transplants are scarce, expensive, and don't even guarantee recovery, a non-invasive alternative could be an absolute game-changer in the market.
"The nine to 15 million people who have fatty liver disease is potentially the total market," Traber says. "So even if you take a very small fraction of that market, you're talking about an enormous market on the multi-billion dollar range. If you think about it, how many diseases are there where there are 15 million Americans that are afflicted and there is absolutely no therapy for? You can’t come up with one that I can think of. So it’s just enormous market for that indication."
The Galectin Effect in Cancer Treatment
The company is also developing a galectin treatment for cancer. Though it is currently engaged in a phase 2 clinical trial for melanoma, the treatment could theoretically be applied to multiple forms of cancer. The advantage of Galectin Theraputics' approach is that it could be synergistic with virtually any of the various immune therapies that are on the market today or currently in development.
"We have a very novel mechanism that is different than any other being used right now to address cancer," Traber says. "We block galectin proteins that are secreted by the vast majority of cancers in high amounts and by doing so, we allow the immune system of the patient to actually attack the tumors."
He goes on to explain that tumors normally secrete large amounts of galectin proteins, which bind to t-lymphocytes and prevent the patient's own immune system from attacking and killing the cancer. So while many companies are currently focused on developing treatments to enhance the human body's immune system, the beneficial impact of these drugs are subdued by the cancer's own defenses. To counter this effect, Galectin Therapeutics is working on a drug that essentially neutralizes the ability of tumors to disrupt the healing agents, thus promoting the normal function and production of T-cells as well as maximizing the effectiveness of other treatments. This approach creates the possibility of combining a more synergistic, two-pronged attack in cancer therapy."
"The size of the market in cancer vaccines is expected to be about $7 billion by 2015, but that’s with only the drugs that are currently in the market," Traber says. "There’s really only two approved kinds of immunologic therapies on the market, but there are literally hundreds that are in various stages of clinical development. So there’s going to be a great explosion in this area, and our drug is potentially synergistic with all of them. The potential over a period of time for our drug would be as big as the cancer vaccine and immunological therapy market."
Getting On the Radar
As noted earlier, Galectin Therapeutics intends to be the leader in a potentially revolutionary medical industry. The company's progress in liver disease treatments has already garnered recognition from some of the key leading figures in the field.
"We’ve received a really terrific response from the liver disease community in general," Traber says. "There’s a real hunger for drugs that could do what our drugs have shown to do in preclinical models. It’s generated a lot of interest because of the underlying results that we’ve gotten in our animal studies, and the fact that they see great promise in this and see it as something that they want to be involved in."
Equally important, the company's shares began trading on the Nasdaq stock exchange in late March, providing increased visibility and accessibility to the investment community, both self-directed and institutional investors. The uplisting was part of a public offering that helped Galectin Therapeutics to raise approximately $10.5 million in net proceeds to help the company achieve its strategic milestones.
"When you talk about a critical inflection point, because of the certain FINRA rules and because of the balance sheet that we had, I think it’s pretty safe to say that somewhere between 95 to 99 percent of all the brokers in America were restricted by their compliance department from mentioning our stock to investors," says Jim Czirr, Executive Chairman of Galectin Therapeutics. "That’s a big detriment and was what we labored underneath. But that onus is gone now and I believe that the combination of the improvement on the balance sheet, the milestones that can be achieved and the Nasdaq listing, we’re collectively in a position where most institutions can invest in our stock."
Operating as a smaller company in its current state, Galectin Therapeutics does understand the significance of increasing its value in the near term by focusing on treatments for important diseases where it can have an impact in the shortest period of time possible. But the company's long-term outlook is much more compelling in that it does hope to revolutionize the way the healthcare industry approaches many major diseases.
"I sincerely believe that 10 years from now, we’ll be considering galectins as the type of target that we now think of for cholesterol enzymes and other things," Traber says. "People are going to be saying how important this target is for a variety of diseases and I think we are in at the ground floor of that, which is very important to us. We are seeing so much evidence of the importance of galectins in a variety of fibrotic and different cancers that this is going to be a real sustaining platform for drug development, and we’re right in at the foundation of it."
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