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29/09/2015

A new experimental drug to reduce clinical progression of primary progressive multiple sclerosis

montalban_884

29/09/2015

Un estudio internacional de fase III demuestra que ocrelizumab, desarrollado por Roche, consigue retrasar en 12 semanas la progresión de la enfermedad, en sus fases iniciales.

A Phase III, randomized and international study (Oratorio) led by Dr. Xavier Montalbán, head of the Clinical Neuroimmunology Service of the Vall d'Hebron University Hospital and head of Cemcat, shows that the administration of ocrelizumab, a new experimental drug developed by http://www.roche.es/" Roche, can reduce in at least 12 weeks clinical progression of primary progressive multiple sclerosis. About 10-15 % of the patients are suffering from this type of multiple sclerosis , the neurological symptoms caused by the disease manifest progressively and they get worse over the time (months or years). Until today, patients did not have any treatment for this disease, so this is the first drug being studied with effective results regarding clinical evolution of primary progressive multiple sclerosis.The Oratorio study has analysed the efficacy of ocrelizumab in 732 patients suffering from primary progressive multiple sclerosis and the main conclusion that has been reached is that the drug is able to stop in at least 12 weeks the progression of the disability in primary progressive multiple sclerosis. Ocrelizumab is a monoclonal antibody designed to selectively attack CD20B proteins which contain cells with an specific type of immunity believed to play a key role in myelin and nerve damage, a common feature among patients with multiple sclerosis. Ocrelizumab binds to CD20 cell surface proteins in order to preserve the most important roles of the immune system.Ocrelizumab was approved in other international clinical trials previously carried out, as the Opera I and Opera II study, to an experimental level for patients with recurrent multiple sclerosis. There was no treatment approved for multiple sclerosis until today but, as Dr. Xavier Montalbán (in charge of the clinical neuroimmunology group at VHIR and PI of the study) claims: "the results of this clinical trial are important as they show how it is possible to administer a new drug to patients with of primary progressive multiple sclerosis which stops clinical progression of the disease in early stages, which means a great advance for these patients" In this sense, Sandra Horning, MD, chief medical officer at Roche and chief for global product development claims that "people with this type of multiple sclerosis feel symptoms that are continuously getting worse after the beginning of the disease and there were no treatments approved until today for this disease which weaken the patient very much. Ocrelizumab is the first drug being still in study which has proved to have a positive clinical effect regarding the progression of this type of multiple sclerosis". A disabling and fast-progressing disease The primary progressive form of multiple sclerosis is a chronic disease which affects about 2.3 million of people worldwide and currently there is no cure for it. Disease is produced when the immune system unusually attacks the nerve isolation (myelin) of the nervous central system (brain and spinal cord) fundamentally affecting the optic nerve causing inflammation and the corresponding damage which manifests in a steady way as different symptoms such as weakness, fatigue and difficulty seeing, which can eventually progress to an important disability.About 1 in ten people with multiple sclerosis are diagnosed with the primary progressive type of the disease. Most of the patients usually feel the first symptoms when they are from twenty to forty years old, making it the first cause of non-traumatic disabling disease in young adults. About Roche in neuroscienceNeuroscience is a focus of research and development of Roche. The aim of the company is to develop treatments and options on the basis of the biology of the nervous system in order to help to improve the quality of life of patients with chronic and potentially devastating diseases. Roche has more than a dozen drug products being clinically studied for diseases such as multiple sclerosis, Alzheimer's disease, spinal muscular atrophy, Parkinson's disease, Down syndrome and autism.

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