MS Treatment That Resets Immune System Shows Promise In Safety Trial

Date: Jun-06-2013A new treatment for multiple sclerosis (MS) that resets the patient's immune system was found to be safe and well
tolerated in a small trial published in Science Translational Medicine this week. And, although not designed to test the
effectiveness of the therapy, the trial also showed promising results in this area.

Another important result is that the therapy does not appear to affect the immune system's ability to defend against
infection.

Current therapies for MS suppress the entire immune system, leaving patients more vulernable to everyday infections and higher
rates of cancer.

The results of the phase 1 trial showed the therapy was safe and well tolerated and also reduced immune system reactivity to
myelin by 50 to 75%, say the researchers.

"The therapy stops autoimmune responses that are already activated and prevents the activation of new autoimmune
cells," says co-senior author Stephen Miller in a statement.

Miller is the Judy Gugenheim Research Professor of Microbiology-Immunology at Northwestern University Feinberg School of
Medicine in Chicago in the US.
MS Is an Autoimmune Disease
MS is an autoimmune disease, a condition where the body's immune system attacks and destroys healthy tissue. In the case of
MS, the healthy tissue is myelin, the protein that insulates the nerves in the spinal cord, brain and optic nerve and stops the
electrical signals from leaking out.

As the myelin is gradually destroyed, patients experience symptoms ranging from mild numbness in the limbs to paralysis or
blindness.

In this study, the researchers used patients' own white blood cells to reset their immune system so it stops attacking and
destroying myelin.
Using MS Patients' Own White Blood Cells to Reset the Immune System
For the study Miller collaborated with researchers at University Hospital Zurich in Switzerland and University Medical Center
Hamburg-Eppendorf in Germany, where the nine patients who took part in the trial were treated.

The researchers filtered the white blood cells out of the patients' blood, processed them and combined them with myelin antigens
(the parts of the myelin protein that the immune system reacts to).

They then injected billions of the processed white blood cells, packed with myelin antigens, back into the patients.

The cells entered the spleen, which filters the blood and helps the body eliminate old and dying blood cells. It is during this
process that immune cells recognize the myelin antigen as harmless. This was confirmed in the patients by immune assays, say
the researchers.

Although nine patients are not enough to give a statistically meaningful result on how well the treatment halted progression of MS,
the patients who received the highests dose of white blood cells showed the greatest reduction in reactivity to myelin.

The main goal of the study was to show the treatment was safe and well tolerated. It showed that injecting up to 3 billion white
blood cells carrying myelin antigens resulted in no adverse effects in patients with MS.
MS Treatment Did not Affect Ability of Immune System to React to Real Pathogens
The trial also showed that the new MS treatment did not reactivate the patients' disease and it did not affect the ability of their
immune system to react to real pathogens.

The researchers tested this last part by checking the patients' response to tetanus. They had all received tetanus shots in their
lifetime, and one month after receiving the MS treatment, their immunity to tetanus remained strong, suggesting the treatment
had only affected their immune system's reaction to myelin.

"Our approach leaves the function of the normal immune system intact. That's the holy grail," says Miller, whose lab has been
working for more than three decades to reach the human trial stage.
Future Developments and Options
With further testing the researchers believe the approach could be used to treat other autoimmune diseases and even allergies.
You simply attach the appropriate set of antigens to the white blood cells.

Miller's lab has already published some papers showing the therapy could be effective in treating type 1 diabetes and airway
allergy (asthma). In a study published in the Journal of Immunology, they describe how they used the method to neutralize peanut allergy in mice, using white
blood cells carrying peanut proteins.

Using a patient's white blood cells is an expensive and labour-intensive way to deliver this therapy. Another recently published
study where Miller and colleagues showed that nanoparticles
can stop MS in mice, suggests nanoparticles may offer a cheaper and more accessible delivery vehicle than white blood cells.
Cour Pharmaceutical Development Company now has the licence for the nanoparticle technology, which is undergoing preclinical
development.

Researchers are now trying to raise $1.5 million to do a phase 2 trial, to see if the new treatment can halt the progression of MS in
humans. The trial has already been approved in Switzerland.

"In the phase 2 trial we want to treat patients as early as possible in the disease before they have paralysis due to myelin
damage," says Miller, "Once the myelin is destroyed, it's hard to repair that."

Funds from the German Federal Ministry for Education and Research and the Cumming Foundation helped pay for the
trial.

Another recently published study describes how researchers in Australia found an immune suppressor protein that may offer a
way to reverse type 1 diabetes and suggests if it works for that disease then it may well work for other autoimmune diseases
like MS.

Written by Catharine Paddock PhD

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