HealthDay Reporter
MONDAY, April 16 (HealthDay News) — An experimental pill reduced the number of lesions in the brains of people with multiple sclerosis (MS), researchers report.
The drug, which currently goes by the name ONO-4641, “actually caused a reduction in relapses, which is somewhat unusual in a study this small and is quite encouraging,” said lead researcher Dr. Timothy Vollmer, a professor of neurology and medical director of the Rocky Mountain MS Center, located at the University of Colorado, in Denver.
The medication is also “more selective than other drugs in its class and hopefully that will provide a better safety profile long-term,” Vollmer said. He added that the aim of the therapy is to prevent MS-linked disability and prevent brain damage.
“We are shifting our therapeutic goals. We are no longer interested in just slowing the disease, we are actually interested in putting patients into what we call a ‘disease activity-free’ state,” he explained.
“And in some patients, with these highly effective therapies, our goal is to induce a remission of symptoms and that’s doable in patients with early disease. The goal is going to treat early and aggressively to prevent brain injury,” Vollmer said.
The results of the phase 2 clinical trial were released April 16 and will also be presented next week at the American Academy of Neurology’s annual meeting in New Orleans.
Commenting on the study, Dr. Gary Birnbaum, director of the Multiple Sclerosis Treatment and Research Center at the Minneapolis Clinic of Neurology, said that ONO-4641,”appears to be similar in mechanism of action to the approved drug, fingolimod (Gilenya), but appears to be more selective in its action.”
Nevertheless, based on the recent post-marketing reports of sudden death in patients on fingolimod, and the data reported in this trial of slowed heart rate in patients receiving ONO-4641, similar safety concerns may arise with this drug, Birnbaum said.
“In addition, the drug induces a lymphopenia [low white blood cell count], indicating it too is an immune suppressant. Immune suppression has its own dangers, as noted with fingolimod, where two patients died of liver infections, and there was an increased risk of skin cancer,” Birnbaum said.
More study is needed to assess the long-term effectiveness and safety of ONO-4641, he said.
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