*3.2.3 Published results*

The safety analysis revealed no clinically significant dose-limiting toxicities at any of the 3 dose levels, with no serious adverse events related to the study drug. None of the patients tested positive for vector neutralizing antibodies, replicationcompetent retrovirus in peripheral blood lymphocytes, antibodies to gp70, or vector integration into the genomic DNA of peripheral blood lymphocytes. According to the RECIST v1.0 evaluations of tumor responses, one patient achieved a complete response, two patients, partial response, and 12 patients, stable disease with 100% disease control rate. The median progression free survival by RECIST v1.0 was 2.7 months, 4.0 months, and 5.6 months at Dose levels I, II, and III, respectively. Median overall survival was 4.3 months, 9.2 months, and 9.2 months at Dose levels I, II, and III, respectively. A dose response relationship was shown between duration of survival and DeltaRex-G dosage (p = 0.03). Consequently, fast track designation was given by the USFDA for a planned Phase 2/3 study using DeltaRex-G as second line therapy for advanced pancreatic adenocarcinoma.
