Oral Cladribine

Phase III Trial Of Oral Cladribine, A Novel Investigational Therapy For Multiple Sclerosis, Begins In The United States
Main Category: Multiple Sclerosis News
Article Date: 05 May 2006 - 0:00 PDT
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Serono (drt-x: SEO and NYSE: SRA) announced today that recruitment in the U.S. is beginning for the Phase III CLARITY study (CLAdRIbine Tablets in Treating MS OrallY Study) of oral cladribine for the treatment of patients with relapsing forms of multiple sclerosis (MS). This multi-national study was successfully initiated outside the U.S. in 2005, and will now expand to include 17 clinical trial sites in the U.S. The study is one of the largest MS trials ever conducted, and enrollment is on track to be completed in 2006.

CLARITY is a two-year, double-blind, placebo-controlled Phase III study of more than 1,200 patients. It is designed to assess patients' clinical relapses, disability progression and MRI (magnetic resonance imaging) brain activity. Previous clinical trials using cladribine administered by injection in patients with MS showed positive effects in reduction of new lesion development in the brain as seen on MRI scans; reductions in relapses were also observed.

"The Phase III CLARITY trial is enrolling at a strong pace, and the addition of US sites will accelerate this pace and bring us one step closer to our goal of making the first oral MS therapy available for people living with this debilitating condition, underscoring our fundamental and long-term commitment to the MS community," said Dr. Paul Lammers, Chief Medical Officer at Serono, Inc. "The formulation of oral cladribine, combined with the proposed short dosing regimen, should help patients to be more compliant with their MS therapy and lighten the patient's treatment burden associated with chronic MS."

"We all are looking forward to the day when there is an FDA approved oral therapy that can affect the underlying disease process in MS," said Dr. John Richert vice president research and clinical programs at the National MS Society. "Clinical studies, such as CLARITY, are an important part of the process leading to the development of these new medications. Those interested in determining whether they are eligible to participate in the clinical trial should speak with their healthcare provider."