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 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”.
