Please see clinicaltrials.gov entry describing the Ocrelizumab PPMS trial: <click here>
This study is based on the postive results of the PPMS Rituximab trial that I have commented on before.
Hawker et al. Rituximab in patients with primary progressive multiple sclerosis: results of a randomized double-blind placebo-controlled multicenter trial. Ann Neurol. 2009 Oct;66(4):460-71.
In the Rituximab study time to confirmed progression between Rituximab and placebo treated groups was not significant. However, subgroup analyses suggest selective B-cell depletion may affect disease progression in younger patients, particularly those with inflammatory lesions on MRI (Gd-enhancing lesions).
Please note that Ocrelizumab is the follow-on compound of Rituximab; both these drugs are monoclonal antibodies that target a protein CD20 that is expressed on B cells. Exactly how these drugs work is not known. However, I suspect that they may work by suppressing EBV infection with the body. The response of MS to anti-CD20 therapies is one of the arguments I use to support my EBV-MS causation theory.
“Our site is now recruiting for the ocrelizumab trial.”
CoI: Multiple
Good luck recruiting with that criterion! Most people with ppms have been on at least some form of previous treatment with lymphocyte trafficking blockers. This trial states it will not accept any patients who have been given pretty much all known lymphocyte trafficking blockers. That kind of limits your talent pool don’t you think?
What's the Death rate, 1 in 1000.Better odds than winning the Lottery !
Re: "What's the Death rate, 1 in 1000.Better odds than winning the Lottery!"I am not sure of the rate; but what ever it is it will almost certainly be higher than the Lottery. You mustn't forget that MS is a bad disease and without taking risks we are unlikely to get on top of this disease. The death rate in the RA and Lupus trials were related to infections, which may not play out in MS as most of these cases were immuno-compromised from previous therapies. The death in the MS trial may or may not be be related to the drug, but until the all the information is in the public domain I am unable to comment on the details.