Omar Khan, M.D.
A Wayne State University School of Medicine neurologist said this week that the announcement of successful results of yet another Phase 3 trial of a new treatment for multiple sclerosis will likely result in a new frontline protocol for patients beginning in 2012.
Physicians and researchers of the Wayne State University Multiple Sclerosis Center began testing Alemtuzumab (trademarked under the name Lemtrada) in 2002. Omar Khan, M.D., professor of Neurology and director of the Multiple Sclerosis Clinical Research Center and Image Analysis Laboratory for the School of Medicine, has served as the principal investigator and member of the U.S. Advisory Committee on the drug for 10 years.
Genzyme, the manufacturer, recently reported positive top-line results for Alemtuzumab against the current standard treatment of interferon beta-1a from a second Phase 3 trial in patients with relapsing-remitting multiple sclerosis.
The data from this second of two such studies, Dr. Khan said, are the “best ever efficacy data in any MS trial in the last 20 years.” Alemtuzumab, he said, significantly reduced the rate of sustained accumulation of disability compared to treatment with interferon beta-1a.
“With the completion of this study, we are now looking at FDA registration and approval in 2012,” said Dr. Khan. “As we speculated, which is now substantiated by this study, Alemtuzumab presents with the best data and sets a new benchmark of efficacy. This is clearly a major breakthrough in the treatment of MS.”
Dr. Khan noted that the long-term safety of the drug must still be studied, but no unexpected or unusual indications have arisen thus far.
Alemtuzumab has been granted fast track designation by the U.S. Food and Drug Administration, according to Genzyme. If the drug wins FDA approval and becomes available in the United States in 2012, there will be demand to switch patients to the new therapy, Dr. Khan said, though he cautioned that each patient’s case should be decided individually.
The drug is administered intravenously once a year. Dr. Khan said a number of patients enrolled in the study have remained stable and free of any further disease activity without receiving any further treatment.
Dr. Khan and colleagues will present the date in a series of presentations at the annual meeting of the American Academy of Neurology in New Orleans in April 2012.
The WSU Multiple Sclerosis Center is one of the leading testing sites with one of the top patient enrollments in the U.S. for the drug.