MAY 28 marks World MS Day, a time meant to raise awareness about the neurodegenera­tive disease multiple sclerosis. MS is a complex autoimmune disease that differs from patient to patient. It differs in the way the disease may manifest itself. It differs in the way the disease progresses. And, it differs in the way an individ­ual’s own immune system turns against his or her central nervous system to wreak havoc. No two MS patients are the same, and yet we continue to treat the approximately 2.3 million people worldwide with MS as if they were.

MS is unpredictable and can give rise to a variety of symptoms that can range from numbness in the limbs to vision loss and paralysis. There are distinct paths the development of the disease takes. In its relapsing remitting form, the disease is marked by flare-ups that worsen and increase with frequency. About 85 percent of all MS patients are initially diagnosed with relapsing remitting MS. Over time, nearly all of them will develop secondary progressive MS, where periods of flare-up give way to a constant state of disability. It is estimated that approximately 30 to 40 percent of individuals with MS have the more advanced, secondary progressive form.

While there have been a series of new drugs to reach the market that promise improved treatments for the disease, these drugs, at best, slow progression of the disease and the frequency of relapses. Unfortunately for patients with secondary progressive multiple sclerosis, there still exists a substantial unmet medical need as there are limited treatment options. Only one product has been approved by the U.S. Food and Drug Administration specifically for the treatment of secondary progressive MS, and that drug suppresses the entire immune system and, therefore, has a side effect profile that limits its long-term use.

On World MS Day, I’m suggesting people pause for a moment to think about cancer. That may sound strange, but consider the lessons we can learn from advances made in the way drugmakers and doctors approach cancer. Cancer, once defined by where in the body it appeared, is now routinely thought of and treated based on the molecular mechanism underlying each patient’s disease. The advent of targeted, personalized therapies has moved cancer treatments toward an era of precision medicine where therapies attack the underlying causes of a patient’s disease. We need to address autoimmune diseases like MS in the same way.

We are on the cusp of new therapies radically changing our approach to disease, not just in cancer, but MS and other diseases as well. My company has been working on a personalized T-cell therapy for MS for the past several years. As World MS Day arrives, we have reached our 180-patient enrollment target for an important clinical trial in patients with secondary progressive MS to evaluate the efficacy of our therapy.

T-cells are one of the types of cells that make up the immune system. Not all T-cells are alike. Each cell, as part of the body’s defense against disease causing substances, targets specific antigens. In the case of MS, the body’s immune system breaks down, which results in a small number of these T-cells attacking the nerve fibers in the brain. Each of these attacking T-cells incorrectly targets a specific peptide that is part of the myelin, the protective sheath that insulates nerve cells, believing such peptides to be foreign. These T-cells treat normal peptides as antigens and attack, destroying the myelin in the process.

What we now believe, though, is that the T-cells that are active in one MS patient may be different from those that are active in another patient in that they attack a different set of myelin peptides. And, in the case of a single patient, the peptides being targeted by the T-cells can change over time. Our approach is to determine the specific peptides a patient’s T-cells are targeting on the myelin and then train the immune system to mute those specific T-cells. We are attempting to restore the function of the body’s immune system through a personalized T-cell therapy to enable the patient to treat the disease itself. In doing so we are attempting to stabilize or possibly reverse the course of the individual’s MS.

Even though I believe we are moving into a new age of personalized medicine, all too often we continue to approach diseases like MS with one-size-fits-all solutions. This does not always yield the best results for the patient. Instead, we should take a lesson from the progress that’s been made in cancer and stop treating multiple sclerosis as if it were a single disease. We need to recognize that not only is every patient unique, but so too is their disease.

Neil Warma
Neil Warma is CEO of The Woodlands, Texas-based Opexa Therapeutics, Inc., which is currently conducting a mid-stage clinical trial of Tcelna, its personalized immunotherapy in development for the treatment of secondary progressive MS.

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