squiffy2
09-11-2007, 09:31 AM
Opexa Therapeutics, Inc, a company involved in the development and commercialisation of cell therapies, today provided an update on its 150-patient Phase IIb safety and efficacy study (TERMS) of Tovaxin® in multiple sclerosis. The trial design is a U.S. multicenter, randomised, double-blind, placebo-controlled study of subcutaneous Tovaxin in subjects with Clinically Isolated Syndrome (CIS) or Relapsing/Remitting Multiple Sclerosis (RRMS).
Trial Highlights:
- All 150 patients have received their first vaccine dose in the five dose vaccine series.
- More than 60% of the total 750 vaccine doses of the study have been delivered.
- Individualised 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.....................................
For the complete article please go to MSRC: MS Research News : Drugs : Tovaxin (http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1312)
Trial Highlights:
- All 150 patients have received their first vaccine dose in the five dose vaccine series.
- More than 60% of the total 750 vaccine doses of the study have been delivered.
- Individualised 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.....................................
For the complete article please go to MSRC: MS Research News : Drugs : Tovaxin (http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1312)