Genzyme’s MS Drug Lemtrada Gets Positive Results in Clinical Trial

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In a second clinical trial for an experimental drug called alemtuzumab (Lemtrada), Genzyme, a sanofi-aventis company, has reported positive results for patients with relapsing-remitting multiple sclerosis (MS). Patients using the drug experienced a reduction in relapse rate as well as a reduction in disability risk.

Relapsing-remitting MS is the most common disease course with the patient experiencing relapses or exacerbations of worsening neurologic function followed by periods of remission.

The Phase III study, named the Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis II (CARE-MS II), included 840 patients who had experienced at least two relapses within the two years prior to entering the trial despite receiving treatment. The patients were randomized to receive either 12 mg daily for five days of alemtuzumab or a three-times-weekly subcutaneous injection of interferon beta-1a (Rebif, EMD Serono, Inc.)

Alemtuzumab is a humanized monoclonal antibody that targets the cell surface glycoprotein CD52 which is highly expressed on T- and B-lymphocytes. Previous research has suggested that these cells may be responsible for the cellular damage in multiple sclerosis. The drug, while appearing to have little or no effect on other cells of the immune system, depletes T- and B-cells and repopulates lymphocytes.

The drug is currently approved under the name Campath for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).
In a Phase II trial, published in the New England Journal of Medicine in October of 2008, Alemtuzumab significantly reduced the rate of sustained accumulation of disability, meaning no worsening of the disease as measured by the Kurtzke Expanded Disability Status Scale (EDSS), a method of quantifying disability in MS.

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Professor Alastair Compston, PhD, chair of the steering committee overseeing the conduct of the study and head of the Department of Clinical Neurosciences at the University of Cambridge, United Kingdom, notes that in the Phase III trial, there was a 49% reduction in relapse rate as compared with those on Rebif. There was also a 42% reduction in risk for sustained accumulation of disability.

Dr. Compston said, "Taken together, the phase 2 and 3 clinical trial data illustrate the promise that alemtuzumab holds as a transformative treatment for people with relapsing MS." Full analysis of the CARE-MS II data will be presented at a forthcoming scientific meeting.

The most common types of adverse events associated with alemtuzumab were infusion-associated reactions such as headache, rash, nausea, hives, insomnia and fatigue. Infections were common in both groups, however those on Lemtrada had more but were predominately mild to moderate in severity. Infections were most common in the upper respiratory and urinary tract. Sinusitis and herpes simplex infections were also noted.

Approximately 16% of those treated with the experimental drug developed an autoimmune thyroid related adverse event, and about 1% developed immune thrombocytopenia. These cases were managed using conventional therapies.

David Meeker MD, president and CEO of Genzyme, said that the company is on track to submit alemtuzumab for review to the US and European Union regulatory authorities in the first quarter of 2012.

For more recent news on advances in the treatment of Multiple Sclerosis, please read:
New Drug for Multiple Sclerosis (Ocrelizumab) Shows Promise in Trials
Saffron Ingredient Shows Promise in Fighting MS

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