Omar Khan, M.D.
French drug manufacturer Sanofi this week announced promising results from clinical trials, including those conducted at the Wayne State University School of Medicine, of a new drug to treat relapsing-remitting multiple sclerosis patients
Omar Khan, M.D., professor of Neurology and director of the Multiple Sclerosis Clinical Research Center and Image Analysis Laboratory for the Wayne State University School of Medicine, has served as the principal investigator and member of the U.S. Advisory Committee on the drug Alemtuzumab since 2002, when early trials began.
“We had several patients participate in the study who have ever since remained stable and free of any further disease activity without receiving any further treatment for their MS,” Dr. Khan said.
“Alemtuzumab could be the first definitive treatment that may eliminate active disease in MS patients, meaning no further relapses, no disease progression and no new lesions in the brain,” he said. “While it may not cure the disease, it may give hope to millions of patients that early intervention with Alemtuzumab may prevent the fear and stigma of the disease in the form of crippling disability and being in a wheelchair. It has been a very rewarding 10-year effort to see this happen with WSU’s participation and leadership.”
Physicians and researchers of the Wayne State University Multiple Sclerosis Center began testing Alemtuzumab in a Phase II trial in 2002 that proved successful and was published in 2008 as a major breakthrough in potential treatment for MS in the New England Journal of Medicine. The Phase II study results showed “very convincingly,” Dr. Khan said, that Alemtuzumab was more effective than high-dose, high-frequency interferon-beta 1a, an FDA-approved therapy for MS. The phase 2 study involved a randomized, blinded trial of 334 patients with previously untreated early relapsing–remitting multiple sclerosis. The patients received either subcutaneous interferon beta-1a three times per week or annual intravenous cycles of Alemtuzumab for 36 months. Alemtuzumab, Dr. Khan noted, significantly reduced the rate of sustained accumulation of disability compared to treatment with interferon beta-1a.
The next step was to conduct Phase III trials for regulatory approval in the U.S. and the rest of the world. That meant two Phase III trials had to be conducted and show the same results as the Phase II trial. The first of the two Phase III trials was completed and the results were released this week. The drug demonstrated a 55 percent reduction in the MS relapse rate over high dose interferon treatment, currently considered one of the first line therapies for MS.
“The results duplicated the relapse rate data to what we saw in the Phase II trial. The Wayne State University School of Medicine has now participated in all clinical trials, with nearly three dozen patients,” Dr. Khan said. WSU is one of the largest recruiters of MS patients for the study.
The second stage of the Phase III trials is to be completed later this year, with plans to present the data at the 2012 American Academy of Neurology meeting. If those clinical trials show results similar to those announced Monday, Dr. Khan said, the drug will then go to the U.S. Food and Drug Administration on a “fast track,” which could mean potential FDA approval within six months.
Alemtuzumab, trademarked under the name Lemtrada, is a monoclonal antibody that targets the cell surface glycoprotein CD52, which is highly expressed on T- and B-lymphocytes. Research suggests that the drug depletes the T- and B-cells that may be responsible for the cellular damage in MS, while sparing other immune system cells.
The drug, administered intravenously once a year, could set the benchmark for efficacy in the treatment of MS, Dr. Khan said. If there are no major safety issues – which appears to be the case based on the date from the Phase III trial released Monday – Alemtuzumab could indeed be considered the first line preferred treatment for MS.
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.