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news.Pipex Pharmaceuticals has initiated patient dosing of Trimesta, its proprietary therapy for multiple sclerosis, in a multi-center Phase II/III clinical trial for the treatment of women with relapsing-remitting MS.
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This clinical trial of Trimesta (oral estriol) has received a $5 million grant from the National Multiple Sclerosis Society (NMSS) in partnership with the National MS Society’s Southern California chapter, with support from the National Institutes of Health (NIH).
The Phase II/III clinical study is a double-blind, placebo-controlled trial that will take place at seven sites in the US and will enroll up to 150 female MS patients. Investigators will administer Trimesta along with Copaxone, an FDA approved therapy for MS to women between the ages of 18-50 who have been recently diagnosed with relapsing-remitting MS.
An initial 22-month Phase II Trimesta trial produced encouraging results, with the total volume and number of enhancing pathogenic myelin lesions (established neuroimaging measurements of disease activity in MS) decreasing during the treatment period as compared to a six-month pretreatment baseline period. The median total enhancing lesion volumes decreased by 79% and the number of lesions decreased by 82% within the first three months of treatment.
Dr Charles Bisgaier, Pipex’s president, commented, “to our knowledge, this is the first gender-specific, oral, potentially disease-modifying agent that has entered later-stage clinical trials for the treatment of MS.”