Potential Treatment for MS Is Safe and Tolerable in Phase I Trial: Study
An American Academy of Neurology (AAN) news release states that a new treatment researchers are currently investigating for multiple sclerosis (MS), is reported to be safe and tolerable in phase I clinical trials. The results yield from a study appearing in Neurology Neuroimmunology & Neuroinflammation, an online, freely accessible specialty medical journal.
According to the release, the phase I studies tested the treatment candidate in humans. Studies with animals indicated that the treatment, known as anti-LINGO-1 or BIIB033, may be able to reverse demyelination of the nerves. Anti-LOGO-1 is designed to block LINGO-1, which is a central nervous system protein that prevents myelination.
During the study, the release says, a total of 72 healthy individuals without MS and 47 individuals with either relapsing-remitting MS or secondary progressive MS received the treatment or a placebo. Healthy participants reportedly received either a placebo or one dose of the drug by an infusion or injection. MS patients received either a placebo or two intravenous doses of the treatment 2 weeks apart. In both groups, the release notes, participants were given varying amounts of the treatment, ranging from 0.1mg/kg to 100 mg/kg.
The release reports that the occurrence of side effects was similar for participants who received the treatment and those who received the placebo. Researchers state that many of the side effects were mild to moderate and were not related to the treatment. These side effects included headaches, upper respiratory infections, and urinary tract infections.
The study states that intravenous doses of 10mg/kg and higher resulted in concentrations of the treatment in the blood that were similar or higher than the concentration linked to 90% of the maximum remyelination effect in studies with rats.
Diego Cadavid, MD, Biogen Idec in Cambridge, Mass, which developed the drug, served as a study author.
“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,” Cadavid says.
Source(s): Newswise, AAN