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Merck Serono concludes Cladribine tablets Phase III trial
PBR Staff Writer Published 18 November 2010
Merck Serono, a division of Merck KGaA, has concluded patient recruitment in a randomized, double blind, placebo-controlled, international Phase III trial of ORACLE MS 1 clinical study.
The Phase III trial is designed to evaluate the therapeutic effects of Cladribine tablets on the time to conversion to multiple sclerosis (MS) in people with a first clinical event suggestive of the disease.
Merck Serono's oral formulation of cladribine, a small molecule that may interfere with the behavior and the proliferation of certain white blood cells, particularly lymphocytes, which are thought to be involved in the pathological process of MS.
Merck Serono Global Clinical Development Neurodegenerative Diseases head Bruno Musch said that the clinical development program of Cladribine tablets is designed to characterise the potential therapeutic effects of Cladribine tablets therapy at the various stages of multiple sclerosis.
"The completion of patient enrollment in the Oracle MS study is a significant milestone as this study will provide insight on the impact of Cladribine tablets therapy on the course of multiple sclerosis when administered early in the disease process, Musch said.