The clinical trial design included five escalating doses of intravenous Rexin-G ranging from 1 x 10e11 cfu twice a week to 4 x 10e11 cfu three times a week for four weeks. Interim analysis showed no dose limiting toxicities in nine evaluable patients who received dose levels 1-3. Furthermore, the analysis showed decrease in tumor size or disease stabilization (by Recist), decreased metabolic activity in tumors (by PET-CT scan), reduction in tumor marker levels, and clinical benefit in patients receiving dose level 3.
The second Phase of the Rexin-G study has now opened wherein six patients will receive dose levels four and five, respectively, as the Phase I/II adaptive study design continues to evaluate the over-all safety of Rexin-G and to determine the optimal dosing regimen for Rexin-G that would document the clinical benefits required to support a Phase II/III pivotal trial.
Sant Chawla, principal investigator of the Phase I/II study, said: “I am happy with the positive results of Rexin-G seen in pancreatic cancer, and look forward to obtaining even better results with progressively higher doses of Rexin-G.”