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Phase 3 Trial of Oral Cladribine Begins, Therapy for Multiple Sclerosis

ROCKLAND, Mass. and GENEVA, May 4 /PRNewswire-FirstCall/ -- Serono (virt-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."

Trial Recruitment Taking Place in 15 States
Currently, there are 17 clinics, medical centers, universities and hospitals recruiting patients to participate in the study in 15 major cities across the country.

Further clinical trial site information is available at http://www.theclaritystudy.com/, or the U.S. National Institutes of Health clinical trial information website at https://clinicaltrials.gov/.

"We are excited to further evaluate oral cladribine for the treatment of MS," said Dr. Dusan Stefoski, M.D., associate professor of the Rush Multiple Sclerosis Center and a clinical investigator for the CLARITY trial. "From my clinical experience, the addition of an oral therapy for MS could improve compliance among patients and potentially change the MS treatment paradigm."

It is estimated that approximately 400,000 Americans are affected with MS, a chronic, progressive autoimmune disease of the central nervous system (CNS). Relapsing forms of MS are the most common. While symptoms of MS are unpredictable and can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination.

About Oral Cladribine
Oral cladribine is a proprietary oral tablet formulation of cladribine that is being studied in an effort to demonstrate possible benefits as a treatment for patients with relapsing forms of MS. Cladribine is a purine nucleoside analogue that interferes with the behavior and the proliferation of certain white blood cells, particularly lymphocytes, which are involved in the pathological process of MS. Through its differentiated mechanism of action, cladribine tablets may offer an effective new option to patients with MS.

Source: Serono

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