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Merck Serono Announces Initiation of the ORACLE MS Trial to Evaluate Cladribine Tablets in Patients at Risk of Developing Multiple Sclerosis
Date:9/17/2008

- ORACLE MS Phase III Trial Will Assess Effectiveness of Cladribine Tablets in Preventing Conversion to Definite Multiple Sclerosis in Addition to the

Fully Enrolled Phase III Pivotal Trial -

- the CLARITY Study -

- for Treatment of Relapsing Forms of Multiple Sclerosis

GENEVA, Sept. 18 /PRNewswire/ -- Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today the initiation of a Phase III trial to evaluate the therapeutic effects of its proprietary oral formulation of Cladribine (Cladribine tablets) in patients at risk of developing multiple sclerosis (MS).

The trial, called ORACLE MS (Oral Cladribine in Early MS) will evaluate the safety and efficacy of two dosage regimens of Cladribine tablets versus placebo in the treatment of patients who have experienced a first clinical event suggestive of MS. Cladribine tablets are currently also being evaluated in a fully enrolled Phase III pivotal trial - the CLARITY(1) study -- for treatment of relapsing forms of MS. As announced in January 2007, CLARITY was the first pivotal trial among all Phase III oral compounds in development for MS to complete enrollment. Cladribine tablets have been granted a fast track designation by the US Food and Drug Administration.

"There is increasing evidence supporting the initiation of treatment with a disease-modifying drug in patients who have experienced a first clinical event suggestive of multiple sclerosis, an initial stage of the disease when clinical manifestations are not necessarily pronounced but where the potential exists for irreversible neurological damage to take place," said Dr. Thomas Leist, Associate Professor of Neurology and Director of the Comprehensive MS Center at Thomas Jefferson University, Philadelphia, PA, and an investigator in the ORACLE MS study. "The ORACLE MS study will evaluate the effectiveness and safety of Cladribine tablets in preventing conversion to
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SOURCE Merck Serono International S A
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