*3.4.3 Published results*

No dose-limiting toxicities were observed at any of the three Dose Levels of DeltaVax, and no deaths that occurred were considered to be related to the treatment. None of the patients tested positive for vector neutralizing antibodies, replication-competent retrovirus in peripheral blood lymphocytes, antibodies to gp70 or vector integration into genomic DNA of peripheral blood lymphocytes. Using RECIST v1.0 criteria, three patients achieved a partial response, nine patients achieved stable disease, and two patients had progressive disease. The median progression free survival was 4.5, 9.0, and 13.0 months for Dose Levels I, II, and III respectively, and the median overall survival was 17, 13 and > 21 months for Dose Levels I, II, III respectively.

Histopathologic examination of patients' residual tumor tissues showed vector localization as well as GM-CSF transgene expression in necrotic tissue, displaying the accuracy in delivery of both treatments. Safety and tolerability are displayed by the lack of adverse reactions associated with the study drugs. The one-year survival rate of 86% in patients who received higher doses of DeltaVax suggests that the combination regimen of DeltaRex-G and Deltavax has significant anti-tumor activity in patients with chemoresistant solid malignancies and B-cell lymphoma. In addition, the substantial increase in progression free survival with each increased dosage of DeltaVax suggests a trend towards a positive dose–response relationship between the two treatments.
