Första patienten inkluderad i MS-studie med vatelizumab

Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), 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.

 

För mer information kontakta:
Tomas Gloveus, Landschef, Genzyme Sverige, 0708-19 80 73, tomas.gloveus@genzyme.com
Eva Laudon Meyer, Medicinsk chef Multipel Skleros, Genzyme Sverige, 070-284 74 80, eva.laudon-meyer@genzyme.com