Survival effect of bi-shRNAfurin/GMCSF DNA-based immunotherapy (FANG) in 123 advanced cancer patients to α-interferon-ELISPTOT response.

3077 Background: Over the last 3 years, follow up in a series of Phase I (study # CL-PTL-101) and phase II studies (study # CL-PTL-105, -107, -114, -110, -112) involving FANG (BB-IND 14205) have been performed involving 123 advanced cancer patients, most of whom previously failed prior systemic therapy. ELISPOT assay which quantitatively measures responding mononuclear cell γIFN release to patient personal tumor was utilized to track immunotherapy activity. Methods: Sequential ELISPOT assessment utilizing patient blood mononuclear cells and autologous tumor tissue as antigen source (harvested prior to immune therapy) were measured at baseline and sequentially afterward. Results: Sixty-four advanced cancer patients received monthly intradermal injections of FANG and 53 had FANG constructed but elected other therapy (No FANG group). Median survival of FANG treated patients was 729 days vs. No FANG patients 260 days, p=0.001. Patients (4%) who were ELISPOT positive at baseline or before receiving FANG or who...