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With $12.2M In CIRM Funding, Caladrius Biosciences Inc (CLBS) Takes On Autoimmune Disease In Type I Diabetes

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Autoimmune diseases account for the most prescriptions filled in the world. The most prescribed drug in the world today is levothyroxin for Hashimoto’s thyroiditis. Levothyroxin is a hormone replacement for the metabolic regulator thyroxin, normally produced by the thyroid, which comes under attack by the immune system in the case of Hashimoto’s.

Autoimmunity not only accounts for just the most prescriptions filled. The most bestselling drug in the world today in terms of revenues is Humira (adalimumab), which primarily treats rheumatoid arthritis, another autoimmune disease.

That autoimmune disorders are responsible for both the most prescribed and the bestselling drugs globally tells us a lot about the pervasiveness of the autoimmune problem. From diseases as devastating as multiple sclerosis where the immune system attacks nerves, to as minor an inconvenience as Hashimoto’s, autoimmunity is becoming a more and more serious problem.

It is theorized and generally accepted by the scientific community that a single cause underlies all, or at least most, autoimmune disorders. That cause is an imbalance between T-effector and T-regulator cells. T-effector cells are responsible for the immune attack against pathogens, and T-regulator cells, or “tregs”, suppress or regulate the effectors. Too little Tregs causes the effectors to go out of control and attack one’s own tissues. Restoring this balance may be key to ending, or at least making a big dent in autoimmunity as a disease class.

The fascinating thing is that this imbalance between effectors and tregs is much more prevalent in developed countries where infectious diseases are less pervasive. A theory known as the hygiene hypothesis states that hygiene and autoimmunity are inversely correlated. The logic being that our immune systems have evolved under much less sanitary conditions over millions of years, and now that they have less pathogens to fight, they tend to be overzealous in more hygienic environments, looking for something to attack.

A more functional, genetic way of looking at the problem is that some people are genetically predisposed to producing more t-effectors than tregs. Why is this? Because such an imbalance may have once been advantageous in terms of making the immune system more aggressive to fight invaders, but now that disease is quite controlled in developed countries, it may actually be a disadvantage leading to autoimmune disease.

The biotech industry has only recently begun developing treatments to correct the imbalance. Trials have already reached the clinic and there is preliminary evidence that rebalancing t-effectors and tregs may actually work towards ending or at least mitigating autoimmune disorders in humans.

The most recent evidence we have is from a small biotech called Caladrius Biosciences Inc (NASDAQ:CLBS). While it is not attempting to cure all autoimmune disorders in one fell swoop, it has seen some significant clinical success with type I diabetes. Type I diabetes, as opposed to type II, is a pure autoimmune disorder. The immune system starts attacking the pancreas at a young age, leading to the death of pancreatic islets and the need for lifelong insulin injections.

But there is a short window of time when the disease can be stopped in its tracks, and this critical concept is what Caladrius has already proven in its early human trials. At the time of diagnosis, 20% of a patient’s islets are typically still functional. If the autoimmune attack can be stopped early enough, insulin independence for these patients can still be achieved.

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