MS: A phase IIa randomized clinical study testing GNbAC1, a humanized monoclonal antibody...

[Bob]

I came across this via a Tweet by the WPI.

The study is testing a monoclonal antibody against the envelope protein of an endogenous retrovirus found expressed in MS lesions. This study only tests that the antibody is safe (in just 10 patients), and it was found to be safe. But perhaps it could lead to some interesting results and one to watch out for in the future?

A phase IIa randomized clinical study testing GNbAC1, a humanized monoclonal antibody against the envelope protein of multiple sclerosis associated endogenous retrovirus in multiple sclerosis patients — A twelve month follow-up
Journal of Neuroimmunolgy.
Tobias Derfuss et al.
August 2015
Published online May 2015
http://www.jni-journal.com/article/S0165-5728(15)00143-5/fulltext

Highlights

• GNbAC1 is a monoclonal antibody targeting an endogenous retroviral protein MSRV-Env.
• MSRV-Env expressed in multiple sclerosis lesions is proinflammatory and myelinotoxic.
• GNbAC1 was tested in ten multiple sclerosis patients at two dosages.
• GNbAC1 appeared safe in the ten patients followed-up during 12 months.
• A proof of concept study is now needed to test this therapeutic approach in MS.

Abstract
GNbAC1 is a humanized monoclonal antibody targeting MSRV-Env, an endogenous retroviral protein, which is expressed in multiple sclerosis (MS) lesions, is pro-inflammatory and inhibits oligodendrocyte precursor cell differentiation. This paper describes the open-label extension up to 12 months of a trial testing GNbAC1 in 10 MS patients at 2 and 6 mg/kg. The primary objective was to assess GNbAC1 safety, and other objectives were pharmacokinetic and pharmacodynamic assessments. During the extended study, no safety issues occurred in the 8 remaining patients. No anti-GNbAC1 antibodies were detected. GNbAC1 appears well tolerated.

 

[Hutan]

The free access article below provides some background information that I found useful in understanding what this is about. (apologies if this is covered elsewhere in the forums)

Curr Neuropharmacol. 2011 Jun; 9(2): 360–369.
Human Endogenous Retroviruses in Multiple Sclerosis: Potential for Novel Neuro-Pharmacological Research
F.P Ryan*

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3131726/

Abstract
There is growing evidence that the env genes of two or more human endogenous retroviruses (HERVs) of the W family are contributing to the inflammatory processes, and thus to the pathogenesis, of multiple sclerosis (MS). Increasing understanding of the human endogenous retroviral locus, ERVWE1, and the putative multiple sclerosis associated retrovirus, or MSRV, and in particular of the HERV-W env sequences associated with these, offers the potential of new lines of pharmacological research that might assist diagnosis, prognosis and therapy of multiple sclerosis.