Express Pharma

Glenmark enrols first patient for phase II trial of GBR 500

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Glenmark has enrollment 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 neuro degenerative disease of the central nervous system (CNS). Uncontrolled inflammation within the CNS leads to inflammatory damage that is associated with demyelinating lesions and neuro degeneration in patients with MS. Vatelizumab is a humanised 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 hypothesised 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.

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.

Commenting on the progress with GBR 500, Dr Michael Buschle, President of Biologics and Chief Scientific Officer, Glenmark Pharmaceuticals said, “We are excited about the commencement of this trial and are pleased with the continued progress of our partnership with Sanofi/Genzyme.”

EP News Bureau- Mumbai

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