Multiple sclerosis (MS) is a disease of the central nervous system in which the immune system attacks the brain and spinal cord, typically resulting in muscle weakness, problems with vision and coordination, pain and, in some patients, cognitive impairments.
The disorder affects approximately 400,000 people in the U.S. and more than 2.5 million people worldwide. Patients with relapsing forms of MS are currently treated with one of three FDA-approved interferon-beta agents or with glatiramer acetate. Unfortunately, these treatments are not effective in a substantial number of patients; therefore, there is an urgent need to develop new and more effective treatments for MS.
A team from the National Institute of Neurological Disorders and Stroke (NINDS) discovered that daclizumab, a humanized antibody to the interleukin-2 receptor alpha chain (IL-2Rα), is effective in treating MS. Daclizumab was first developed and approved in the U.S. for preventing organ transplant rejection. A team at the National Institutes of Health (NIH) led a small clinical trial of patients with MS who did not respond to interferon-beta alone and found that adding daclizumab improved patient outcome. Patients who received the combined therapy had a 78-percent reduction in new brain lesions and a 70-percent reduction in total lesions, along with other significant clinical improvements. Daclizumab was also tolerated very well. Based on this trial, the NIH team anticipated that daclizumab and other anti-IL-2Rα antibodies would be useful either as combination therapy or stand-alone treatment.
The technology is exclusively licensed to Abbott (formerly Facet Biotech/PDL), which in collaboration with Biogen Idec has initiated and is currently enrolling patients for a Phase III study.
The technology is exclusively licensed to Abbott (formerly Facet Biotech/PDL), which in collaboration with Biogen Idec has initiated and is currently enrolling patients for a Phase III study. The licensee recently concluded a study that enrolled 230 patients with MS that confirmed using daclizumab as an add-on therapy helped patients whose symptoms had relapsed while they were taking interferon-beta. Several other small-scale clinical trials at NIH have led to the conclusion that daclizumab monotherapy is effective in most patients who experienced persistent MS disease activity with interferon-beta therapy.
While the NINDS team helped transfer this technology from bench to bedside by conducting clinical trials and disseminating the results of their findings, the technology transfer professionals at NIH transferred this valuable technology to biopharmaceutical companies to ensure that FDA-approved therapies are developed that can further help in treating MS worldwide.