1104. Phase II Study of Lucanix(TM) a Transforming Growth Factor [beta]2 (TGF-[beta]2) Antisense Gene Modified Allogeneic Tumor Cell Vaccine in Non Small Cell Lung Cancer (NSCLC)

Lucanix(TM) is a non-viral gene based allogeneic tumor cell vaccine. Preclinical studies demonstrate enhancement of tumor antigen recognition as a result of TGF-β2 inhibition.We performed a randomized dose variable phase II trial involving stage II, IIIA, IIIB and IV NSCLC. Each patient received one of 3 doses (1.25, 2.5, 5.0x10 7 cells/injection) of Lucanix(TM) on a monthly or every other month schedule to a maximum of 16 injections. Immune function, safety and anticancer activity were monitored.Seventy five patients (2 stage II, 12 IIIA, 15 IIIB, 46 IV), received a total of 550 vaccinations. No significant (≥ grade 3) adverse events probably or definitely associated with administration of the vaccine were observed. A dose-related survival difference was demonstrated in patients who received ≥ 2.5 x 10 7 cells/injection versus those who received