Cladribine enters trial in patients at risk of MS

Merck Serono, a division of Germany's Merck KGaA, has initiated a Phase III trial to evaluate the therapeutic effects of cladribine tablets in patients at risk of developing multiple sclerosis. The ORACLE MS will trial evaluate the safety and efficacy of two dosage regimens 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, late-stage pivotal trial - the CLARITY study - for treatment of relapsing forms of MS. In January 2007, CLARITY was the first pivotal trial among all Phase III oral compounds in development for MS to complete enrollment. The agent has 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 Thomas Leist, an investigator in the ORACLE MS study.