Technology Behind TSO Based On Hygiene Hypothesis

The drug TSO was developed by Dr. Weinstock in collaboration with researchers from the University of Iowa, where he used to work before joining Tufts. The technology behind TSO is based on “hygiene hypothesis”, according to which certain countries have become too clean for their own good.

In countries where such hygienic conditions do not prevail, the human body comes in contact with millions of micro-organisms present in dirt.

However, in countries where too much attention is paid to the basic hygiene, these micro-organisms are killed by the anti-bacterial soaps and the sanitizing gels before they can enter the human body. The researchers have opined that the absence of exposure to certain parasites of the intestine, because of these sanitary measures, divests the body of a chance to modulate its immune system. This may result in the development of autoimmune diseases.

This hygiene hypothesis is further corroborated by studies which have found that autoimmune diseases are more frequently seen in the developed countries compared to the developing nations. Even in the developed countries, these diseases are more common in families belonging to the upper income bracket, wherein stringent attention is paid to the hygiene conditions.

Millions suffer from autoimmune diseases

According to latest statistics, more than 700,000 Americans suffer from Crohn’s disease, an autoimmune disease affecting the bowel. Around 50 million people in the U.S. are suffering from rheumatoid arthritis, while another 7.5 million people suffer from psoriasis, a skin condition wherein the patients develop thick red skin, with scales which are flaky, silver-white patches on the skin.

The commonly employed mode of treatment for autoimmune diseases is injecting a drug which blocks a protein named as the tumor necrosis factor. This, in turn, results in a depression of the body’s immune system and relief from the symptoms of the disease for a period of time. However, the main pitfall of this form of treatment is that as the body’s defense is lowered, there is an increased risk of developing opportunistic infections, the most common of which are tuberculosis and cancers. As TSO does not cause any permanent side effect because of its short stay in the body, the company launching it feels that its acceptance will be high. The company officials say that they had no problem finding volunteers for the clinical trials.

Side effect of TSO

As per Bobby Sandage Jr., the chief executive officer at Coronado’s, the only side effect that one-third of the people who tried TSO experienced was some discomfort of the gut, like abdominal cramps or diarrhea, after taking the first or the second dose. However, these symptoms disappeared spontaneously with subsequent doses. According to Sanger, patients must continue to take the drug in order to keep the symptoms away.

According to a market research by BBC Research, the share of these drugs is expected to grow in the mid-single-digit percentages through 2016. Coronado Biosciences Inc. expects to capture a big share of this market with TSO.

One important aspect that the company will have to look into before getting an approval by the FDA is the proper cleaning of the eggs. Normally, all biologic drugs are purified by means of extreme heat or radiation. But this cannot be done with TSO as the eggs need to stay alive for modulation of the immune system. At present, the company is employing an acid wash technique to clean the eggs. The eggs are not damaged by this technique as they have already evolved to stay alive in the acidic conditions present in the pig’s stomach.

Only time will tell, if this new form of treatment for autoimmune diseases can live up to the expectations of the public. For the time being, the company seems fairly optimistic.