Ocrelizumab is a humanized anti-CD20 monoclonal antibody. It targets mature B lymphocytes[1] and hence is an immunosuppressive drug candidate. It is under development by Hoffmann–La Roche‘s subsidiary Genentech, and Biogen Idec.
It had reached Phase III clinical trials for rheumatoid arthritis[2] and lupus erythematosus,[3]and Phase II for multiple sclerosis[4] and hematological cancer.[5]
In March 2010, Roche announced the suspension of clinical trials in rheumatoid arthritis and lupus erythematosus. This step followed excess deaths due to opportunistic infections. Development for multiple sclerosis continues.[6]
In October 2010 Roche announced 24 week results from the PhII study in relapse remittingMS. The drug demonstrated a statistically significant reduction in disease activity as measured by brain lesions (measured by MRI scans) and relapse rate compared to placebo. Both doses (200 mg & 600 mg) were well tolerated.Anti-B cell therapy with rituximab has been shown to be safe and beneficial for RA treatment. Rituximab is approved and marketed for the treatment of RA in patients who have failed other therapies. Ocrelizumab, a fully human monoclonal antibody against CD20, may have less immunogenicity and less complement activation than rituximab which, theoretically, may reduce the development of drug neutralizing antibodies and infusion reactions. Here, Genovese at al report the results of a Phase I/II dose finding study of Ocrelizumab in RA patients who have failed other DMARDs (including prior TNF inhibitors).
- K. John Morrow Jr (2008-06-15). “Methods for Maximizing Antibody Yields”. Genetic Engineering & Biotechnology News (Mary Ann Liebert, Inc.). p. 36. Retrieved 2008-07-06. (Note: information included in this article only found in table present in print version of article.)
- Kausar, F; Mustafa, K; Sweis, G; Sawaqed, R; Alawneh, K; Salloum, R; Badaracco, M; Niewold, TB et al. (2009). “Ocrelizumab: a step forward in the evolution of B-cell therapy”. Expert opinion on biological therapy 9 (7): 889–95. doi:10.1517/14712590903018837.PMID 19463076.
- http://www.clinicaltrials.gov/ct2/show/NCT00539838 A Study to Evaluate Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus (BEGIN)
- http://www.clinicaltrials.gov/ct2/show/NCT00676715 A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis.
- Hutas, G (2008). “Ocrelizumab, a humanized monoclonal antibody against CD20 for inflammatory disorders and B-cell malignancies”.Current opinion in investigational drugs (London, England : 2000) 9 (11): 1206–15. PMID 18951300.
- Katie Reid (2010-03-08). Update 2. Roche suspends arthritis treatment after deaths. Reuters. Retrieved 2010-03-08
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