CAMBRIDGE, Mass. -- (Business Wire)
Genzyme,
a Sanofi company, announced today enrollment of the first patient in a
multicenter Phase II clinical trial to evaluate Genzyme’s
investigational infusion therapy vatelizumab in patients with relapsing
remitting multiple sclerosis (RRMS). The trial, called EMPIRE, is
designed to assess the efficacy of vatelizumab vs. placebo in RRMS
patients. The safety, tolerability and pharmacokinetics of vatelizumab
will also be assessed.
Multiple sclerosis is a chronic inflammatory demyelinating and
neurodegenerative disease of the central nervous system (CNS).
Uncontrolled inflammation within the CNS leads to inflammatory damage
that is associated with demyelinating lesions and neurodegeneration in
patients with MS. Vatelizumab is a humanized monoclonal antibody that
targets VLA-2, a collagen-binding integrin expressed on activated
lymphocytes. The mechanism of action of vatelizumab is not known,
although it is hypothesized to block VLA-2 on activated immune cells,
leading to interference with collagen-binding in areas of
inflammation, and thus may reduce the inflammatory cascade in MS.
“Continuous inflammation and neurodegeneration from the onset of
multiple sclerosis can lead to significant disability,” said Eva
Havrdova, MD, PhD, MS Center, Department of Neurology, First Medical
Faculty, Charles University, Prague. “The EMPIRE trial should enable us
to assess vatelizumab’s ability to impact the acute inflammatory
components of MS and evaluate its potential as an effective MS
treatment.”
Genzyme is developing vatelizumab in MS in partnership with Glenmark
Pharmaceuticals. In addition to its marketed therapies, Genzyme has an
MS R&D pipeline focused on investigational treatments to address unmet
needs for relapsing and progressive forms of MS through research in
selective immunomodulation, neuroprotection and remyelination.
“We are pleased to commence patient enrollment for our vatelizumab trial
in relapsing MS,” said David Meeker, President and CEO, Genzyme. “This
milestone demonstrates Genzyme’s long-term commitment to MS and aligns
with our pipeline strategy to focus on areas of unmet need.”
About EMPIRE
EMPIRE is a global phase 2a/2b double-blind, randomized,
placebo-controlled study assessing the efficacy, safety and
dose-response of vatelizumab in patients with active RRMS. The study
duration is 12 weeks. The study is expected to enroll 168 patients at 55
sites in 10 countries. For more information about the vatelizumab trial,
visit www.clinicaltrials.gov.
About Genzyme, a Sanofi Company
Genzyme has pioneered the development and delivery of transformative
therapies for patients affected by rare and debilitating diseases for
over 30 years. We accomplish our goals through world-class research and
with the compassion and commitment of our employees. With a focus on
rare diseases and multiple sclerosis, we are dedicated to making a
positive impact on the lives of the patients and families we serve. That
goal guides and inspires us every day. Genzyme’s portfolio of
transformative therapies, which are marketed in countries around the
world, represents groundbreaking and life-saving advances in medicine.
As a Sanofi company, Genzyme benefits from the reach and resources of
one of the world’s largest pharmaceutical companies, with a shared
commitment to improving the lives of patients. Learn more at www.genzyme.com.
About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes
therapeutic solutions focused on patients’ needs. Sanofi has core
strengths in the field of healthcare with seven growth platforms:
diabetes solutions, human vaccines, innovative drugs, consumer
healthcare, emerging markets, animal health and the new Genzyme. Sanofi
is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Genzyme® is a registered trademark of Genzyme Corporation.
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Sanofi Forward Looking Statements
This press release contains forward-looking statements as defined in
the Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical facts.
These statements include projections and estimates and their underlying
assumptions, statements regarding plans, objectives, intentions and
expectations with respect to future financial results, events,
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regarding future performance. Forward-looking statements are generally
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and uncertainties, many of which are difficult to predict and generally
beyond the control of Sanofi, that could cause actual results and
developments to differ materially from those expressed in, or implied or
projected by, the forward-looking information and statements. These
risks and uncertainties include among other things, the uncertainties
inherent in research and development, future clinical data and analysis,
including post marketing, decisions by regulatory authorities, such as
the FDA or the EMA, regarding whether and when to approve any drug,
device or biological application that may be filed for any such product
candidates as well as their decisions regarding labelling and other
matters that could affect the availability or commercial potential of
such product candidates, the absence of guarantee that the product
candidates if approved will be commercially successful, the future
approval and commercial success of therapeutic alternatives, the Group’s
ability to benefit from external growth opportunities, trends in
exchange rates and prevailing interest rates, the impact of cost
containment policies and subsequent changes thereto, the average number
of shares outstanding as well as those discussed or identified in the
public filings with the SEC and the AMF made by Sanofi, including those
listed under “Risk Factors” and “Cautionary Statement Regarding
Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for
the year ended December 31, 2013. Other than as required by applicable
law, Sanofi does not undertake any obligation to update or revise any
forward-looking information or statements.
Contacts:
Genzyme Media Relations
Erin Walsh, +1 617-768-6881
erin.walsh@genzyme.com
Source: Genzyme
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