Tovaxin™

Parent companies: Opexa Therapeutics

• This is a T-cell vaccine given via subcutaneous injection every four weeks. In this process, myelinreactive T cells are removed from a small amount of the patient's blood, inactivated, and then injected back into the patient. The body's immune system then protects the myelin from these cells.
  
  
• The TERMS placebo-controlled, one-year study in 150 patients with CIS and RRMS to evaluate Tovaxin's efficacy, safety, and tolerability has been completed. The treatment was found to be safe, but did not achieve statistical significance in the primary endpoint, which was a reduction in the cumulative number of gadolinium-enhancing lesions.
  
  
• There was an annualized relapse rate of 0.34 per year (or one relapse roughly every three years) in the placebo group and 0.21 per year (or roughly one relapse every five years) in the Tovaxin group, representing a 37-percent decrease. There was also a 42-percent reduction in new gadoliniumenhancing lesions. The drug was well tolerated with mild skin reactions in some patients; no serious safety concerns were raised by this study.
  
  
• In 70 patients who had at least one relapse in the 12 months prior to enrolling in the study and who had no previous exposure toMS therapy, Tovaxin reduced their annualized relapse rate by 64 percent compared to placebo. The overall annualized relapse rate for Tovaxin-treated patients dropped to 0.18 relapses per patient per year by the end of the 52-week study (this is slightly less than one relapse every five years). Additionally, 76 percent of Tovaxin-treated patients remained relapse-free at one year compared with 60 percent of placebo patients.
  
  
• A larger study in RRMS patients is planned.