- One-Year Phase II Data Presented at the 2010 ACTRIMS Meeting
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) reported today new one-yeardata from a Phase II study with teriflunomide, a novel oral disease modifierbeing investigated for the treatment of relapsing multiple sclerosis (RMS).Study results demonstrated an improvement in outcomes, with a consistentsafety profile with the data from a previous Phase II monotherapy study, inpatients treated with interferon beta (IFN-[BETA]) - a standard therapy inRMS - and receiving teriflunomide 7mg or 14mg, compared with patients treatedwith IFN-[BETA] and receiving oral placebo.
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The findings were the subject of the leading oral presentation at theAmerican Committee for Treatment and Research in Multiple Sclerosis meeting(ACTRIMS) in San Antonio, TX, USA. This study is part of a comprehensiveclinical development program for teriflunomide both in monotherapy and inadjunct therapy in MS patients.
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Although this Phase II study (n=116) was not powered to test forefficacy, patients taking 7mg or 14mg teriflunomide in adjunct to stable doseIFN-[BETA] experienced a significant relative risk reduction (86%; p=0.0005and 82.8%; p<0.0001 respectively) in the number of gadolinium enhancing T1(T1-Gd) lesions on brain magnetic resonance imaging compared with patientstaking stable dose IFN-[BETA] with placebo. No unexpected safety findingshave been showed with teriflunomide during the one-year period of the studyas compared to the initial six-month period. Discontinuations due totreatment-emergent adverse events (TEAEs) were low and numerically similar inthe three groups (placebo: 2; 7mg: 3; 14mg: 3).
"These full-year exploratory study results are encouraging as theydemonstrate significant improvement in disease activity based on MRI and anacceptable safety profile associated with teriflunomide when added on top ofstable therapy with IFN-[BETA]," said Mark S. Freedman, HBSc, MSc, M.D.,Professor of Neurology, Department of Medicine, University of Ottawa,Ontario, Canada. "Adjunct therapy could fill an unmet medical need for thosepatients who are on interferon therapy but have some disease activity asmeasured by MRI or relapse rate. We hope to replicate the results in a PhaseIII study program."
A dose-dependent trend toward a relative risk reduction in the volume ofbrain lesions was observed with teriflunomide 7mg or 14 mg groups when usedas adjunct therapy compared with placebo (72.1%; p=0.11 and 70.6%; p=0.01respectively). There was also a dose-dependent trend to a reduction inannualized relapse rate of 32.6% (p=0.43) and 57.9% (p=0.11) in 7mg or 14mgteriflunomide adjunct groups respectively compared to IFN-[BETA] with placebo.
The most frequently reported treatment emergent adverse events were upperrespiratory tract infections as a whole (placebo: 17.1%; 7mg: 16.2%; 14mg:23.7%), mainly nasopharyngitis and sinusitis, all types of headaches(placebo: 7.3%; 7mg: 5.4%; 14mg: 18.4%), all gastrointestinal disorders(placebo: 24.4%; 7mg: 18.9%; 14mg: 31.6%). White blood cell counts decreaseswere numerically comparable in both teriflunomide and placebo treatmentgroups (placebo: 3; 7mg: 3; 14mg: 4) and no patients discontinued treatmentdue to neutropenia or infection. Hepatic TEAEs were mainly asymptomatic liverenzyme elevation; mostly alanine aminotransferase (ALT) increased, notexceeding three times the upper limit of the norm and no cases of concurrentincrease of ALT and total bilirubine were reported.
About teriflunomide
Teriflunomide is a new oral disease modifier that blocks de novopyrimidine synthesis thus reducing T- and B-cells proliferation with nocytotoxicity. A comprehensive clinical development program for teriflunomidehas been launched in monotherapy (Phase III studies are ongoing) and inadjunct therapy (Phase II studies are closed). This Phase II study with oncedaily oral teriflunomide on top of IFN-[BETA] was a multicenter,placebo-controlled, double-blinded, randomized study, conducted in relapsingmultiple sclerosis patients. The primary objective of the study was toevaluate the tolerability and safety of teriflunomide 7mg and 14mg in adjuncttherapy with IFN-[BETA]. The one-year results of this study presented thisyear during the ACTRIMS congress complement the 24-weeks study resultspresented last year at the European Committee for Treatment and Research inMultiple Sclerosis congress (ECTRIMS). Results from a second Phase II studywith teriflunomide in adjunct therapy with glatiramer acetate (GA) comparedwith matching placebo added to GA, were also presented this year during theAmerican Academy of Neurology (AAN) meeting.
About Multiple Sclerosis
Multiple sclerosis (MS) is one of the most disabling diseases in youngpatients beside accidents. Today, over two million people around the worldsuffer from MS. MS is the result of damage to myelin - a protective sheathsurrounding nerve fibres of the central nervous system. When myelin isdamaged, this interferes with messages between the brain and other parts ofthe body. Multiple sclerosis is a very variable condition and the symptomsdepend on which areas of the central nervous system have been affected. Thereis no set pattern to MS and everyone with MS has a different set of symptoms,which vary from time to time and can change in severity and duration, even inthe same person. Management of MS is complex; early intervention in thepathological process is essential in order to delay disease progression or atleast, slow it down. It involves several layers of health and socialservices, as well as various healthcare professionals. Although there is noknown cure for multiple sclerosis, several therapies are proven to be helpfulbut effective new oral therapies are eagerly awaited.
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers,develops and distributes therapeutic solutions to improve the lives ofeveryone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York(NYSE: SNY). For more information, please visit:http://www.sanofi-aventis.com.
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