The double-blind, placebo-controlled trial will take place at seven sites in the US, enrolling up to 150 female MS patients who have been recently diagnosed with relapsing-remitting MS. Trimesta will be given in combination with Teva Pharmaceuticals’ subcutaneously injected Copaxone, a standard treatment for MS.
Doctors have known for decades that women often experience a sharp drop in MS disease symptoms during the course of pregnancy, specifically in the third trimester when the levels of estriol is being produced at their highest level by the placenta. A recent study published in the New England Journal of Medicine found that relapse rates were significantly reduced by 71% through the third trimester of pregnancy from prebaseline levels and relapse rates then increased by 120% during the first three months postpartum before returning to prepregnancy rates.
Trimesta is an estriol-based treatment which has been approved and marketed throughout Europe and Asia for approximately 40 years for the treatment of post-menopausal hot flashes, but has never been introduced in North America. Pipex has an exclusive worldwide license with UCLA (through the Regent of the University of California) to the intellectual property rights surrounding Trimesta.
The trial has received a $5 million grant from the National Multiple Sclerosis Society in partnership with the National MS Society’s Southern California chapter, with support from the National Institutes of Health, the company said.