Tovaxin update from Opexa
Posted: Tue Sep 11, 2007 7:31 am
You all (trial participants) are following this more closely than I am, so I don't know if this is old news...
Opexa Therapeutics Gives Update on Phase IIb Trial of Tovaxin(R) for Treatment of Multiple Sclerosis
Sep 11 2007, Business Wire - Opexa Therapeutics, a company involved in the development and commercialization 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, randomized, double-blind, placebo-controlled study of subcutaneous Tovaxin in subjects with Clinically Isolated Syndrome (CIS) or Relapsing/Remitting Multiple Sclerosis.
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.
-- 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 chief executive officer of Opexa Therapeutics, stated, "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." McWilliams continued, "We are encouraged that the diverse myelin peptide reactive profile of each patient that we have identified thus far in the study brings us closer to realizing the promise of individual therapy in general, and specifically supports our individualized therapy approach to the treatment of multiple sclerosis."
http://www.genengnews.com/news/bnitem.a ... e=22892993
Opexa Therapeutics Gives Update on Phase IIb Trial of Tovaxin(R) for Treatment of Multiple Sclerosis
Sep 11 2007, Business Wire - Opexa Therapeutics, a company involved in the development and commercialization 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, randomized, double-blind, placebo-controlled study of subcutaneous Tovaxin in subjects with Clinically Isolated Syndrome (CIS) or Relapsing/Remitting Multiple Sclerosis.
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.
-- 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 chief executive officer of Opexa Therapeutics, stated, "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." McWilliams continued, "We are encouraged that the diverse myelin peptide reactive profile of each patient that we have identified thus far in the study brings us closer to realizing the promise of individual therapy in general, and specifically supports our individualized therapy approach to the treatment of multiple sclerosis."
http://www.genengnews.com/news/bnitem.a ... e=22892993