- 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
- 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.