Biogen to publish data on two-step assay for anti-JC virus antibody detection

Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced data has been published in the Annals of Neurology on an investigational, two-step assay to detect anti-JC virus (JCV) antibodies in human serum and plasma. This assay is currently being evaluated in clinical studies as a potential tool for risk stratification in TYSABRI^® (natalizumab)-treated patients. Data from this preliminary analysis have been released online and will be published in the journal's September issue.

“These data support our ongoing clinical studies to assess the clinical utility of this assay and our commitment to further mitigating the rare risk of PML in TYSABRI-treated patients.”

Detection of anti-JCV antibodies may provide a means to segment patients into groups at higher risk or lower risk for developing progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection. In order to develop PML, it is believed that a person must experience a convergence of viral and environmental factors, one of which is being anti-JCV antibody positive. The publication describes the development and validation efforts undertaken to date, as well as preliminary findings on the prevalence of anti-JCV antibodies in multiple sclerosis (MS) patients from the Safety of TYSABRI Redosing and Treatment (STRATA) study. Plasma and serum samples were also analyzed from 17 TYSABRI-treated patients who were later diagnosed with PML. These data showed that all 17 patients were anti-JCV antibody positive prior to the onset of PML.

"We believe an assay with the ability to detect anti-JCV antibodies will be useful in our efforts to stratify patients for the risk of developing PML. It also has the potential to change the clinical management of MS patients," said Alfred Sandrock, M.D., Ph.D., senior vice president of neurology research and development at Biogen Idec. "These data support our ongoing clinical studies to assess the clinical utility of this assay and our commitment to further mitigating the rare risk of PML in TYSABRI-treated patients."

Source : Biogen Idec