Phase 2 Studies
Two double-blind, randomized, controlled trials were conducted studying recurrence-free and overall survival rates for cancer vaccine-treated patients with melanoma. The Trials include POL 91-22 and POL 89-38 with a total of 154 patients studied.
POL 91-22, a Phase 2 Proof of Concept study is believed to be the only double-blind, randomized Phase 2 clinical trial to show a statistical significant improvement in RFS for cancer vaccine-treated patients with melanoma. POL 91-22 confirmed the safety of the vaccine with no grade 3 or 4 toxicity. The median time to disease progression in POL 91-22 vaccine treated patients was 2.5 times longer (1.6 years compared with 0.6 years) than for patients receiving a placebo vaccine. This difference was statistically significant (p=0.03) in a multi-variable model including other risk factors found to influence the survival of patients with stage III melanoma. Overall survival was 40% longer (3.8 years compared with 2.7 years) in the melanoma vaccine-treated patients, but the difference was not statistically significant.
Polynoma’s primary technology, seviprotimut-L, was formerly known as POL-103A
POL 89-38 was a randomized Phase 2 clinical trial comparing quadravalent versus trivalent vaccines. Quadravalent is the precursor to the current vaccine used for the Company’s Phase 3 trial. Analysis of POL 89-38 data fully supports Polynoma’s strategy as the data show the trivalent vaccine to have 86% longer median recurrence-free survival rate than the null vaccine with the effect modifier analysis providing evidence of consistent effect. The RFS Hazard Ratio estimate for the trivalent vaccine was 0.407, representing a lower vaccine hazard rates of 59% for the trivalent vaccine.