Tovaxin
Other names:
In development for: Relapsing remitting MS
Status: Phase II
Last updated: November 2011
How does it work?
Tovaxin is an autologous T-cell vaccine, which means it is prepared from a sample of the patient's own cells. Myelin-reactive T-cells are extracted from the blood and irradiated to produce a vaccine. When the vaccine is injected, the body sees these modified T-cells as being foreign and attacks them, priming the immune system to attack non-irradiated, myelin-reactive T-cells as well.
How is it given?
The prepared vaccine is injected under the skin.
Clinical studies
In a small prelminary study, Tovaxin showed promise, reducing relapses by 90%.
Phase IIb TERMS study
150 participants with relapsing remitting MS or clinically isolated syndrome (CIS) too part in the Tovaxin for Early Relapsing Remitting MS (TERMS) study. 100 participants received Tovaxin and 50 received placebo. Subjects received either five subcutaneous injections of Tovaxin or placebo at weeks 0 (study initiation), 4, 8, 12, and 24.
First analysis of the data, presented at ECTRIMS 2008 failed to show a significant effect of Tovaxin on the number of active lesions as measured by MRI scans. Subsequent analyses of subsets of the participants have been published and presented at international conferences.
The manufacturer, Opexa, is planning to develop phase II clinical trials for secondary progressive MS.
References
Fox E, et al.
A randomized clinical trial of autologous T-cell therapy in multiple sclerosis: subset analysis and implications for trial design.
Multiple Sclerosis Journal 2011 November 7. [Epub ahead of print]
Read abstract