Clinical Trials
Phase II Studies

Phase II Studies

Two double-blind, placebo controlled trials were conducted to assess safety and efficacy of seviprotimut-L.

POL 91-22

POL 91-22 was a double-blind, placebo controlled Phase II clinical trial to assess recurrence-free survival (RFS) and overall survival (OS) in 38 patients with Stage IIIB/C melanoma. The median RFS in vaccine treated patients was 2.5 times longer (1.6 years compared with 0.6 years) than for those receiving placebo. 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 vaccine treated patients, but the difference was not statistically significant.
POL 91-22 chart GG7, showing Recurrence-Free Survival over Months

Clinical Cancer Research (2001), Vol. 7, 1882-1887

POL 89-38

POL 89-38 was a double-blind, placebo (inactive shed antigens) controlled Phase II clinical trial to compare to vaccine formulations – T (seviprotimut-L) and Q (precursor to seviprotimut-L).  116 patients with Stage IIB/C-IV melanoma were studied to assess recurrence-free survival (RFS).
POL 89-38 chart GG5, showing Recurrence-Free Survival over Months
POL 89-38 chart GG6, showing Recurrence-Free Survival over Months

Unpublished data; data on file