Cladribine: A New Oral Medication for the Treatment for Multiple Sclerosis

In 2009, German drug maker Merck KGaA expected to seek United States and European Regulatory (Food and Drug Administration U.S.A) approval for the first oral medication cladribine for the treatment of multiple sclerosis (MS): Preventing sporadic symptoms of multiple sclerosis a neurological disease. 1 In some people multiple sclerosis can lead to permanent disability. 4 "Multiple sclerosis affects more than a quarter of a million people in the United States." Statistically twice as many women are diagnosed with MS then men in their early years (between ages 20 and 40 4), and people of northern European heritage are more likely affected than those of other racial heritage. 3 The Food Drug Administration has granted Fast Track approval for cladribine: Expedite review and development of new drugs for serious or life-threatening conditions for unmet medical needs. Currently injectable drugs are available to treat multiple sclerosis, however according to Dr. John Richert, Vice President, Research and Clinical Programs, at the National Multiple Sclerosis Society said: "Having an effective oral therapy for MS would be a major step forward in improving quality of life for people with MS." 2

Normally electrical signals pass quickly and easily between the brain and all part of the body, because of the insulation layers called myelin, serves to surround neurons in the brain and spinal cord. Multiple sclerosis occurs as a result of the destruction of the insulating layer myelin, and the subsequent formation of scar tissue (plaque) over the affected area, slows down or disrupts the efficient delivery of nerve messages. 3 The break-down of myelin sheath (fatty substance that insulates the nerve fibers in the brain and spinal cord) caused by an autoimmune disease (A condition in which the immune system attacks healthy cells in the body as if they where foreign substances): During the process antibodies and white blood cells destroy the myelin layer. 4 Researchers in Germany discovered a genetic mutation (called PTPRC) or abnormal protein on the surface of white blood cells (lymphocytes) believed to be attributed to the breakdown of myelin (autoimmune disease). According to Norbert Sommer, of the Department of Neurology, Philipps University estimates twenty or more than thirty other genes susceptible to cause multiple sclerosis. 5 When the brain and spinal cord fail to communicate affects vision, balance, coordination, strength, sensation and bodily function. 3

According to Dr, Lee Dunster, head of research for the Multiple Sclerosis Society in the United Kingdom, Merck Serono (German drug-maker) expected to report within the next few months (from beginning of the year 2009), data regarding the evaluation of a two year study (Phase three study - CLARITY (CLAdRIbine Tablets Treating MS OrallY) 2) oral medication to treat MS among 1,326 participating patients, randomly divided into three groups: "Two groups received different doses of cladribine and one group received fake pills." Patients who received cladribine experienced up to a sixty percent reduction in the relapsing symptoms of MS (depending on the dosage 1). 6 Cladribine combats the genetically abnormal white bloods cells (particularly lymphocytes) involved in the autoimmune disease attributed to multiple sclerosis. 2 According to Dr. Lee Dunster: "He said cladribine appeared to be twice as effective as current primary treatment for MS." 6

Cladribine currently prescribed to treat leukemia, only for short periods of time. Reported known side effects oral medication cladribine include increased chance of infection, fatigue, and anemia. However, long term usage of cladribine for multiple sclerosis (lifelong condition) is unknown and thus being evaluated 6

Cladribine may be included in the next list of assessments according to the National Institute of Health and Clinical Excellence (NICE). 7

References:

1.) Merck's Multiple Sclerosis Pill Prevents Relapses (update 2) - http://www.bloomberg.com/apps/news?pid=20601202&sid=a8Z.z68PpfNc

2.) Oral Cladribine for Treatment of Multiple Sclerosis Awarded Fast Track Status by FDA - http://www.docguide.com/news/content.nsf/news/852571020057CCF6852571F0004A384A

3.) multiple sclerosis - http://www.answers.com/topic/multiple-sclerosis

4.) Multiple sclerosis - http://www.cnn.com/HEALTH/library/multiple-sclerosis/DS00188.html

5.) Polymorphism discovered years ago is linked to multiple sclerosis - http://www.genomenewsnetwork.org/articles/12_00/MS_CD45_snp.shtml

6.) Merck: New pill may work for MS -

http://www.katu.com/news/medicalalert/38282269.html

7.) Cladribine Trial Results, Multiple Sclerosis - http://www.medicalnewstoday.com/articles/136647.php