BY ED SUSMAN
LISBON, Portugal—In early trial results, the investigative agent ublituximab completely reduced brain lesions in patients with relapsing multiple sclerosis treated up to 48 weeks, researchers reported here at the Congress of the European Academy of Neurology.
The primary endpoint of the phase 2 study was to determine if treatment with ublituximab reduced levels of B cells. Ublituximab is a novel glycoengineered antiCD20 monoclonal antibody.
For the study, 48 patients were included in six different cohorts of eight patients each; the patients were about 40 years old; most were women who had been diagnosed with MS for about eight years.Twelve patients were assigned to placebo to assess safety data but switched to the active agent after one month.
One woman dropped out of the study due to pregnancy; another patient withdrew from the trial, reported Edward J. Fox, MD, PhD, FAAN, clinical associate professor of neurology at the University of Texas Dell Medical School in Austin.
“In all the patients and in all of the cohorts we saw a 99 percent reduction in B cells, so by week four there is an almost complete reduction of circulating CD20 cells counts,” Dr. Fox said.
Of the 14 patients who completed the 48-week study, “no gadolinium enhancing lesions were detected in any subjects,” he said. Of the 46 patients who completed the 24-week evaluation on the antiCD20 monoclonal antibody, there was also a complete absence of T1 gadolinium-enhancing lesions compared to a mean of 3.80 lesions at baseline, a difference that was statistically significant, Dr. Fox said in his oral presentation.
The study looked at various doses of ublituximab as well as various infusion times. Most of the patients were able to tolerate a one hour infusion treatment.
The agent was well tolerated, Dr. Fox said. Three patients reported severe fatigue and one person experienced a severe upper respiratory infection. Twenty patients reported 41 infusion reactions, all of which were determined to be mild or moderate. There were no drug-related discontinuations from the study, he said. No deaths occurred during the study, he noted. The safety results represent about 11 months of follow-up.
“The data safety monitoring board has reviewed safety labs and adverse events for all subjects, and has not found any laboratory abnormalities or safety signals that would warrant a change in protocol,” Dr. Fox said.
Commenting on the trial, Ralf Gold, MD, PhD, chairman of the department of neurology at Ruhr University Bochum in Germany, told the Neurology Today Conference Reporter: “These were interesting first results with this new compound ublituximab, but we really must wait for results from larger randomized studies to determine if these initial good outcomes are maintained. Once we see those results we will have to determine where this agent will fit into the treatment of people with multiple sclerosis,” Dr. Gold said.”.
Dr. Fox received funding from the study by TG Therapeutics of New York City, which developed the monoclonal antibody.
LINK UP FOR RELATED INFORMATION