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Teriflunomide Successfully Reduces Relapses and is Well Tolerated in Multiple Sclerosis Patients
Date:10/15/2010

for the treatment of multiple sclerosis with a comprehensive clinical development program which has been launched in monotherapy. First Phase II study results of the safety and efficacy of teriflunomide monotherapy in MS were published in Neurology in 2006. In addition to the TEMSO trial, two other Phase III trials, TOWER and TENERE, are ongoing in RMS patients. A Phase III study, TOPIC, is also underway in early MS or CIS (Clinically isolated syndrome). Teriflunomide has also been evaluated as an adjunct therapy to either interferon beta or glatiramer acetate in two Phase II studies. Results of these studies were presented earlier this year during the American Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and American Academy of Neurology (AAN) meetings respectively. Phase II studies with teriflunomide (7 and 14mg) in adjunct with IFNbeta demonstrated an improvement in MRI outcomes, with a consistent safety profile in patients treated with the adjunct therapy compared to patients treated with IFNbeta and receiving placebo. In the other Phase II study, teriflunomide in adjunct to glatiramer acetate (GA) was well-tolerated compared to patients receiving GA and placebo and showed a numerical trend for the reduction in number and volume of gadolinium enhancing T-1 brain MRI lesions in the adjunct arm compared to the placebo with GA arm.

About the TEMSO Study

TEMSO is a 2-year randomized, double-blind, placebo-controlled multinational study including 1,088 RMS patients aged 18-55 years from 21 countries, with an Expanded Disability Status Scale (EDSS) is less than or equal to 5.5 and at least one relapse in the previous year or at least 2 relapses in the preceding 2 years. Patients were randomized to placebo or teriflunomide, 7 or 14mg, once daily and followed for 108 weeks. The primary endpoint was annualized relapse rate defined as the number of confirmed relapses per patient-year. The key secondary endpoint was the time to sust
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SOURCE Sanofi-aventis
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