Paris (ots/PRNewswire) - Sanofi-aventis announced
today the initiation of a multinational Phase III study evaluating
the efficacy and safety of two doses of once daily teriflunomide (7mg
or 14mg) versus placebo in patients with relapsing multiple sclerosis
(RMS) treated with interferon beta (IFN beta). Teriflunomide is a
novel oral disease modifier developed by sanofi-aventis which is
being investigated in a large Phase III clinical development program.
It includes studies of teriflunomide in monotherapy for the treatment
of RMS and in clinically isolated syndrome as well as adjunct
"Initiation of the TERACLES study is a tremendous milestone as it
is the first ever Phase III study of an oral drug in adjunct therapy
to be launched in multiple sclerosis," said Marc Cluzel, M.D., Ph.D.,
Executive Vice President, Research & Development, sanofi-aventis. "We
are confident that teriflunomide is an excellent candidate for
assessing innovative adjunct therapy in multiple sclerosis
considering the positive effect observed when it was used in adjunct
with interferon beta in the Phase II study."
Specifically, the TERACLES study will evaluate whether once daily
oral teriflunomide 14 or 7mg, in patients treated for at least 6
months on a stable dose of IFN beta prior to randomization, can
reduce the annualized relapse rate (primary endpoint) compared to
IFN beta plus oral placebo tablets. The main secondary endpoints of
the study are to document the disease activity measured by MRI, the
time to disability progression and overall safety.
"The purpose of the TERACLES study is to assess the clinical
benefits of teriflunomide as an adjunct therapy in patients with
relapsing multiple sclerosis," said Mark S. Freedman, HBSc, MSc,
M.D., Professor of Neurology, Department of Medicine, and University
of Ottawa, Ontario, Canada. "We hope that this study will replicate
the additional efficacy and safety profile we observed in the Phase
II trial with teriflunomide in adjunct with interferon beta, and
bring an innovative therapeutic approach to this patient population."
The Phase II study results presented this year during the ACTRIMS
congress showed that teriflunomide in adjunct with IFN beta
significantly improved disease control (evaluated by MRI activity)
beyond IFN beta plus oral placebo at one year, with a trend towards
fewer clinical relapses and with a consistent safety profile with the
data from a Phase II monotherapy study.
Approximately 240 study sites in 28 countries are targeted for
participation in the TERACLES study which will involve 1455 RMS
patients. The first patient is expected to be enrolled before the end
of this year and the trial will end once the last patient recruited
has received at least 48 weeks of treatment.
Teriflunomide is a new chemical entity being studied in a
far-reaching and ambitious clinical program including more than
3,500 patients in 36 countries. Teriflunomide has previously 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. In one of this
Phase II study, teriflunomide in adjunct to glatiramer acetate (GA)
was well-tolerated compared to patients receiving GA and placebo.
Although there was a numerical trend for the reduction in number and
volume of gadolinium enhancing T-1 brain MRI lesions in the adjunct
arm compared to placebo with GA, the relative effect was not as
robust as that observed for teriflunomide with IFN beta.
Teriflunomide is also being investigated in a monotherapy clinical
development program. TEMSO Phase III trial positive results have been
presented during the last European Committee for Treatment and
Research in Multiple Sclerosis (ECTRIMS) congress and showed that
teriflunomide successfully reduces annualized relapses rate (primary
study endpoint) vs placebo and was well tolerated in MS patients. Two
other Phase III trials, TOWER and TENERE, are also ongoing in RMS
patients. A Phase III study, TOPIC, completes the clinical
development in early MS or CIS (Clinically isolated syndrome).
About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic, unpredictable and
progressively disabling disease with a substantial burden on
patients. MS patients typically are diagnosed at a young age and they
face a lifetime of uncertainty with gradually declining health.
Today, over two million people around the world suffer from MS. MS is
the result of damage to myelin, a protective sheath surrounding nerve
fibres of the central nervous system. When myelin is damaged, this
interferes with messages between the brain and other parts of the
body. Multiple sclerosis is a very variable condition and the
symptoms depend on which areas of the central nervous system have
been affected. There is no definite 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 in the same person.
Management of MS is complex; early intervention in the pathological
process is recommended in order to delay disease progression or at
least, slow it down. A complex support system is required for the
care of MS patients, including health and social services, as well as
various healthcare professionals. Although there is no known cure for
multiple sclerosis, several therapies are proven to be helpful but
there remains an unmet need for new oral therapies with proven
efficacy and good tolerability as well as good long term safety.
Sanofi-aventis, a leading global pharmaceutical company,
discovers, develops and distributes therapeutic solutions to improve
the lives of everyone. Sanofi-aventis is listed in Paris and in New
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