Early Results Promising for MS Drug
Multiple Sclerosis Patients on Oral Drug Fingolimod Had Few Relapses
Sept. 13, 2006 -- Patients with relapsing multiple sclerosis responded well to the experimental drug fingolimod, giving new hope for an oral MS drug, new research shows.
The findings are published in the latest New England Journal of Medicine.
If the drug is shown to be both effective and safe in larger and longer studies, it could soon offer MS patients something they have not had in the past -- an effective treatment that is taken in pill form, instead of by injection or infusion.
Fingolimod, which is manufactured by Novartis Pharmaceuticals, is one of several experimental, orally delivered drugs that are currently under development for the treatment of multiple sclerosis. Novartis is a WebMD sponsor.
About 2 million people worldwide have MS, which is the leading cause of disease-related neurologic disability among young adults.
Currently available treatments effectively reduce relapse rates in about 30% of patients, but many patients do not stay on the drugs because of adverse reactions and difficult side effects.
"There has been a crying need for better therapies for MS," National MS Society director of biomedical research Patricia O'Looney, MD, tells WebMD. "These are exciting preliminary findings for an experimental oral therapy for MS, but larger and longer term studies are needed to determine if this drug lives up to its early promise."
Trapping T Cells
Although the exact cause of MS remains a mystery, most experts now consider it an autoimmune disease. Immune cells are believed to be responsible for the destruction of the protective coating, called myelin, which surrounds the nerves in key areas of the brain and spinal cord.
This destruction hinders the nerves' ability to send electrical signals, resulting in problems with muscle movement, coordination, balance, and cognition. In its later stages, MS can leave patients paralyzed, but it is not usually fatal.
Out-of-control T cells (a type of immune cell) are thought to attack the myelin, causing the damage, and it is these cells that are targeted by the new therapy.
T cells and other immune cells act like generals in an army, involved in protecting the body. In people with autoimmune diseases, however, these immune cells can become the enemy, attacking various parts of the body.
Fingolimod, also known as FTY720, essentially traps T cells in the lymph nodes, keeping them out of the blood and away from the central nervous system where they do their damage.
In the newly published study, paid for by the drug's manufacturer, MS patients were treated with one of two fingolimod doses for up to a year.
In the first six months of the study, 255 patients received either a once-a-day oral dose of 1.25 milligrams of fingolimod, 5 milligrams of the drug, or a placebo. During the second six months the remaining patients on a placebo were switched to the active drug.