The trial was conducted in China using the vaccination technology exclusively licensed to Opexa.
The results demonstrated that T-cell vaccination was well tolerated and, importantly, induced T-cell regulatory immune responses which collectively correlated with substantial clinical improvement in treated patients.
Using the American College of Rheumatology (ACR) criteria to measure reduction in joint swelling, substantial clinical improvements were observed for were observed for ACR 20 (73.3%), ACR 50 (67.7%) and ACR 70 (55.3%).
Overall there was a significant reduction in swollen and tender joint counts. The observed changes in the clinical parameters correlated with a significant reduction from baseline in serum markers of inflammation, including erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and rheumatoid factor (RF).
“The fact that T-cell vaccination induces regulatory immune responses that are associated with improved clinical and laboratory variables in RA patients suggest that further development of this novel technology is warranted,” said David McWilliams, president and CEO of Opexa.