Shepherd Center Working at the Forefront of Testing New Multiple Sclerosis Drugs
Lisa Dryden had leg weakness because of multiple sclerosis (MS) and no options for improving it. The available medications either didn’t work or had run their course.
She had resolved to cope as best she could with the tightness and spasticity that made it difficult to walk and the extreme fatigue that overcame her. But at an MS support group meeting, she saw a pamphlet that gave her hope. Shepherd Center was recruiting patients for clinical trials.
Lisa, 57, a former nurse who lives in Midland, Ga., near Columbus, joined a clinical trial for Ampyra (dalfampridine), an oral medicine designed to improve conduction in damaged nerves. Half of the enrolled patients received a placebo, or sugar pill, but she could tell immediately she was taking the medication. She felt more stable and fluid. She even began walking for exercise.
“It was so beneficial,” says Lisa, who has secondary progressive MS and still takes Ampyra, which was approved by the U.S. Food and Drug Administration (FDA) in 2010. “I could maintain my lifestyle and not get worse.”
Nine of the 13 new MS drugs that have been developed in the past 18 years were studied at Shepherd Center, giving patients early access to new therapies. Shepherd played a key role in advancing MS treatment. But most importantly, the MS research brought opportunity where there was none.
“Research has given us the ability to change the course of a once-untreatable disease,” says Ben Thrower, M.D., medical director of the Andrew C. Carlos Multiple Sclerosis Institute at Shepherd Center.
Issi Clesson, RN, MSCN, CCRP, director of clinical research, recalls when she began caring for MS patients as a nurse in 1990. “We literally had nothing to offer patients,” she says.
But soon, Shepherd Center was able to provide Copaxone (copolymer-1 or glatiramer acetate) through a clinical trial. The synthetic protein blocks T-cells that damage myelin, the coating of nerve fibers. For the first time, a drug was able to slow the progression of the disease and prevent relapses. Copaxone received approval from the FDA in 1996.
Beta interferon drugs were developed at about the same time. Shepherd Center was a clinical trial site for three such drugs: Avonex, Betaseron and Rebif.
Researchers continued to explore different approaches to stop the immune system from attacking myelin. Tysabri (natalizumab) is a monoclonal antibody that blocks immune cells from crossing the blood-brain barrier and entering the brain and spinal cord. Shepherd patients were among the first to receive Tysabri infusions as part of a post-approval clinical trial.
“It was effective in limiting the number of relapses, as well as in preventing the development of new or enlarging lesions visible on the MRI,” Clesson says. While not a cure, it is a valuable tool to prevent disease progression.
More recent drugs, such as Gilenya (fingolimod) and Tecfidera (dimethyl fumarate), offer similar benefits but as oral drugs, rather than injections or infusions. Shepherd Center was part of clinical trials for both. In all clinical trials, Shepherd carefully screens patients and monitors participants for side effects.
“MS is so individualized. What works for one person may not work for another,” says Carlyn Kappy, RD, LD, CCRP, Shepherd Center research quality manager. “That’s why having plenty of options is so important.”
Lisa recently completed a trial with Tcelna, a biopharmaceutical made from T-cells in her own blood. The trial isn’t yet complete, but she is upbeat about the results. And she feels thankful for Shepherd Center’s contribution to the research.
“Hopefully, they’ll come up with something that will help regenerate the nerves,” she says. “I’m very positive about all the efforts they’re putting into trying to find a cure.”
MS Drugs that Were Studied at Shepherd Center
- Amypyra (dalfampridine) approved by the FDA in 2010
- Avonex (interferon beta-1a) approved in 1996
- Betaseron (interferon beta-1b) approved in 1993
- Copaxone (copolymer-1 or glatiramer acetate) approved in 1996
- Gilenya (fingolimod) approved in 2010
- Lemtrada (alemtuzumab) approved in 2014
- Rebif (interferon beta-1a) approved in 2002
- Tecfidera (dimethyl fumarate) approved in 2013
- Tysabri (natalizumab) approved in 2006 (reintroduced)
Written by Michele Cohen Marill
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 neurological 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 740 inpatients, nearly 280 day program patients and more than 7,100 outpatients each year in more than 46,000 visits.