Tcelna™ (formerly Tovaxin®)
Experimental Medications: Other Therapeutic Strategies
- Administered as five subcutaneous injections per year
- Tcelna is being studied in SPMS
Tcelna is a T-cell vaccine. In the process of administering this vaccine, myelin-reactive 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 may then potentially protect the myelin from these cells.
The TERMS placebo-controlled, one-year study in 150 people with clinically isolated syndrome (CIS) and RRMS to evaluate Tcelna’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.
The placebo group did, however, experience an annualized relapse rate (ARR) of 0.34 per year (or one relapse roughly every three years), while the Tcelna group had an ARR of 0.21 per year (or roughly one relapse every five years), representing a 37-percent decrease. The drug was well tolerated with mild skin reactions in some patients; no serious safety concerns were raised by this study. In a subgroup of 70 patients who had at least one relapse in the 12 months prior to enrolling in the study and who had no previous exposure to MS therapy, Tcelna reduced their annualized relapse rate by 64 percent compared to placebo. Additionally, 76 percent of Tcelna-treated patients remained relapse-free at one year compared with 60 percent of placebo patients.
After re-branding this agent as Tcelna, a new clinical trial initiative was launched in 2012. Tcelna is being studied in a Phase II trial in SPMS in the Abili-T study.25 This is a placebo-controlled two-year trial, evaluating brain atrophy on MRI as the primary outcome, and delay in accumulation of sustained disability as the secondary outcome. The trial has fully enrolled 190 patients and data is expected in the second half of 2016. Tcelna has been granted Fast Track designation by the FDA in SPMS.