Shepherd Center investigates new therapy that uses a person’s own immune system to help fight MS
ATLANTA – People with multiple sclerosis (MS) urgently need new treatments to halt the condition, and hope is on the horizon with a new clinical trial under way at Shepherd Center.
The hospital is one of 30 sites in the United States and Canada participating in a clinical trial to study whether an investigational therapy using a patient’s own immune cells can help stabilize or stop the progression of secondary progressive multiple sclerosis (SPMS). People with SPMS have moved beyond the initial period of relapsing-remitting MS, and their condition has begun to worsen more steadily.
“This is a group of individuals with MS who have not had many treatment options available, so there is a lot of excitement about this study,” said Carlyn Kappy, RD, LD, CCRP, the study coordinator at Shepherd Center.
Eligible study participants are being randomized to receive either placebo or the investigational T-cell immunotherapy called Tcelna™, which is manufactured by Opexa Therapeutics, Inc. Encouraging results from earlier Tcelna trials in MS patients, including some with SPMS, prompted the U.S. Food and Drug Administration to grant it fast-track designation for SPMS.
To develop the therapy, Opexa isolates the “bad” T-cells (myelin reactive T-cells) from a patient’s blood sample and expands them to generate enough reactive T-cells to treat a patient for one year (five doses). The myelin reactive T-cells are thought to cause the inflammation that is the hallmark sign of MS. During the final dose preparation, the myelin reactive T-cells are modified to make the cells unable to replicate. The modified reactive T- cells are then reintroduced to the patient via an injection, which should stimulate the body’s immune system to reduce the number reactive T-cells.
“We are essentially vaccinating them against their own MS,” explained Ben Thrower, M.D., medical director of the Andrew C. Carlos Multiple Sclerosis Institute at Shepherd Center. “The hope is that the body will recognize these cells and trigger an immune response.”
If this new therapy works, it would give patients a customized therapy from the start.
“The immunology of MS is so different from one person to the next, so it’s a little bit of trial and error to find the right fit,” Dr. Thrower said. “This new approach would allow us to treat an individual based on their unique disease.”
Tcelna is also thought to have a lower risk of side effects because, unlike many other therapies used to treat this type of MS, it does not suppress the immune system. In the early 1990s, doctors believed the best way to manage the overactive immune response typically seen in MS was to crush it with chemotherapy and later with immune modulators, including beta interferons, but there were a lot of side effects.
“Existing medications allow us to treat symptoms of MS, but they may also put the patient at risk for other health problems and conditions,” Dr. Thrower explained. “Newer medications have taken us a step in the right direction, but we still find many patients on immune modulators don’t respond very well.”
As of mid-May 2013, six Shepherd Center patients have been screened to take part. Participants must be able to walk to some extent on their own with or without an assistive device such as a cane, be between ages 18 and 60 and will need to stop taking any other treatments to slow disease progression if they decide to pursue the trial. Patients are given just five shots of the treatment or placebo a year. Researchers will evaluate the percentage of brain change at 24 months, disease progression, and changes in disability and annual relapse rates.
Dr. Thrower noted a lot of excitement about this study. “People with secondary progressive MS often feel left out [of clinical trials],” he said. “With this study, we are closer than ever to a tailored therapy.”
The National Multiple Sclerosis Society reports more than 2 million people have MS worldwide; of these, an estimated 25 to 35 percent may have SPMS.
An initial analysis of the study results is expected in 2016. For information about this trial contact Carlyn Kappy, RD, LD, CCRP, at 404-367-2620 or firstname.lastname@example.org.
Shepherd Center, located in Atlanta, Georgia, is a private, not-for-profit hospital specializing in medical treatment, research and rehabilitation for people with spinal cord injury, brain injury, multiple sclerosis, spine and chronic pain, and other neuromuscular conditions. Founded in 1975, Shepherd Center is ranked by U.S. News & World Report among the top 10 rehabilitation hospitals in the nation. In its more than four decades, Shepherd Center has grown from a six-bed rehabilitation unit to a world-renowned, 152-bed hospital that treats more than 935 inpatients, 541 day program patients and more than 7,300 outpatients each year.