Pipex Pharmaceuticals' Oral TRIMESTA Initiates Dosing in Phase II/III Clinical Trial for Multiple Sclerosis
16 Jul 2007 -- Pipex Pharmaceuticals announced today that it has initiated patient dosing of TRIMESTA (oral estriol), its proprietary therapy for multiple sclerosis, in a multi-center Phase II/III clinical trial for the treatment of women with relapsing-remitting MS
Pipex Pharmaceuticals a specialty pharmaceutical company developing innovative late-stage drug candidates for the treatment of neurologic and fibrotic diseases, announced today that it has initiated patient dosing of TRIMESTA (oral estriol), its proprietary therapy for multiple sclerosis (MS), in a multi-center Phase II/III clinical trial for the treatment of women with relapsing-remitting MS. This clinical trial 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).
Dr. Rhonda Voskuhl, professor of neurology at the University of California, Los Angeles and inventor of TRIMESTA, commented, "We are delighted to be enrolling so shortly after recently initiating the Phase II/III clinical trial."
Dr. Charles Bisgaier, Pipex's President, stated, "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."
Dr. Bisgaier went onto say, "Given the convenience of an oral drug therapy, such as TRIMESTA, we have received a lot of positive patient interest in this study and hope to continue enrolling at this positive rate."
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.
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