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news.Opexa Therapeutics has reported that all 150 patients in its Phase IIb safety and efficacy study of Tovaxin in multiple sclerosis have received their first vaccine dose in the five-dose vaccine series.
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The trial design is a US multicenter, randomized, double-blind, placebo-controlled study of subcutaneous Tovaxin in subjects with clinically isolated syndrome or relapsing/remitting multiple sclerosis. More than 60% of the total 750 vaccine doses of the study have been delivered, Opexa said.
Individualized Tovaxin formulations for all 150 patients have been manufactured, with more than 95% of them being unique myelin epitope profiles as identified by Opexa's epitope analysis assay. The variety among the formulations highlights the diversity of myelin epitopes contributing to the disease and supports the individualized therapy approach of Opexa's Tovaxin therapy.
The data safety monitoring board has met three times and reported no safety issues and recommends continuing the trial as planned.
David McWilliams, president and CEO of Opexa Therapeutics, said: “I am pleased by the steady progress of the trial and recommendation of the data safety monitoring board and we now look forward to reporting 52-week results in the second half of 2008.”