Phase III Trial of Oral Cladribine Begins in the US:
"Serono announced 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.

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.

"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....."