NEW TREATMENT FOR MULTIPLE SCLEROSIS
A new treatment under investigation for
multiple sclerosis (MS) is safe and tolerable in phase I clinical trials,
according to a study published August 27, 2014, in Neurology®
Neuroimmunology & Neuroinflammation, a new online-only, freely accessible, specialty
medical journal. The publication is part of the Neurology® family of journals, published by the American
Academy of Neurology
The phase I studies
were the first to test the drug candidate in humans. Studies with animals showed
that the drug, which is called anti-LINGO-1, or BIIB033, may be able to reverse
the demyelination of the nerves. Anti-LINGO-1 blocks LINGO-1, a central nervous
system protein that prevents myelination. Current treatments for MS work to
reduce new damage to the brain, but do not repair new or past damage.
In MS, the body's
immune system begins to attack the myelin that acts as insulation around the
nerves in the central nervous system. This makes it more difficult for the
nerves to send messages to and from the brain and spinal cord.
In the study, 72
healthy people without MS and 47 people with either relapsing-remitting MS or
secondary progressive MS were given the drug or a placebo. The healthy
participants received either a placebo or one dose of the drug by an infusion
or injection. The people with MS received either placebo or two intravenous
doses of the drug two weeks apart. In both groups, participants received
varying amounts of the drug, ranging from 0.1 mg/kg to 100 mg/kg.
The occurrence of side
effects was similar for people who received the drug and those who received the
placebo. Most side effects were mild to moderate and were not related to the
drug. Side effects included headaches, upper respiratory infections and urinary
tract infections. There were no serious side effects or deaths.
There were no
significant changes in vital signs, EKGs or other safety tests of the drug.
Intravenous doses of
10 mg/kg and higher resulted in concentrations of the drug in the blood that
were similar to or higher than the concentration that was associated with 90
percent of the maximum remyelination effect in studies with rats.
"With these
results we have been able to start phase II studies to see whether this drug
can actually repair the lost myelin in humans and have any effect on restoring
physical and cognitive function and improving disability," said study
author Diego Cadavid, MD, of Biogen Idec in Cambridge, Mass., which developed
the drug. Cadavid is a member of the American Academy of Neurology.
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