Tuesday, October 13, 2015

Positive Trial Results for Ocrelizumab in Primary Progressive MS

After lots of hype and buildup ahead of the conference, the pharmaceutical company Roche-Genentech finally revealed a bit more than simply “positive results” from three pivotal Phase III studies of the experimental MS therapy ocrelizumab in relapsing MS and primary progressive MS (PPMS). While relapsing MS has 13 approved therapies and other treatments which are used off-label, such as rituximab, effective treatment for PPMS has continued to be elusive.

What is ocrelizumab?

Ocrelizumab is a humanized (10 percent mouse, 90 percent human-derived) monoclonal antibody designed to target a selective group of immune cells - CD20+ B-cells - which have been implicated in the damage of myelin, the fatty substance that protects nerve cells and helps to speed the transmission of nerve signals throughout the body. In clinical trials, ocrelizumab 600 mg was administered by intravenous (IV) infusion every six months, given as two 300 mg infusions spaced two weeks apart in the ORATORIO trial, while repeat rounds in the OPERA I and II trials were given as a single 600 mg dose infusion.

Ocrelizumab works in the same way as rituximab (Rituxan), a chimeric (100 percent mouse-derived) monoclonal antibody that attaches to CD20 cell surface proteins and causes certain B-cells (but not stem cells or plasma cells) to self-destruct. Rituxan is used to treat rheumatoid arthritis (RA), non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), granulomatosis with polyangitis (GPA) and microscopic polyangitis (MPA). Rituxan is also used off-label for a number of other autoimmune diseases including MS and neuromyelitis optica (NMO). Patents protecting Rituxan (jointly marketed by Genentech and Biogen) from generic competition begin to expire in 2015.

Read this post in its entirety:
Is Ocrelizumab The Next Game-Changer in MS Treatments?

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