Cladribine for multiple sclerosis: review and current status.
In the 1990s, cladribine was developed as an adenosine deaminase-resistant nucleoside analog with selective lymphotoxic specificity in the hope that it might become useful in the treatment of some lymphoid neoplasms and autoimmune disorders. Several clinical trials demonstrated very significant effectiveness and safety of cladribine in the cure of hairy-cell leukemia, and the control of many other lymphoid malignancies. Cladribine was also extensively tested in selected autoimmune disorders, most notably in multiple sclerosis, with evidence of efficacy, tolerability and acceptable side effects/toxicity. The previous clinical studies and current status of cladribine for the treatment of multiple sclerosis are considered in this drug profile. In January 2005, Serono and IVAX announced plans to initiate a Phase III study of a specially formulated oral tablet of cladribine (Mylinax, Serono and IVAX) for the treatment of relapsing forms of multiple sclerosis. The proposed study will be the first large multicenter randomized controlled clinical trial of oral cladribine in multiple sclerosis.
Sipe
Jack C
JC
Department of Molecular and Experimental Medicine, The Scripps Research Institute, and Scripps Clinic, 10550 North Torrey Pines Road (MEM-215), LaJolla, CA 92037 USA. jcsipe@scripps.edu
D017338:Cladribine / Q000737:chemistry / Q000494:pharmacology / Q000627:therapeutic use*; D004347:Drug Interactions; D005104:Expert Testimony; D006801:Humans; D007166:Immunosuppressive Agents / Q000737:chemistry / Q000494:pharmacology / Q000627:therapeutic use*; D015201:Meta-Analysis as Topic; D009103:Multiple Sclerosis / Q000188:drug therapy* / Q000378:metabolism; D011358:Product Surveillance, Postmarketing
D007166:Immunosuppressive Agents; D017338:Cladribine