Phase I study of sequential targeted gene delivery: Intravenous infusions of Rexin-G followed by Reximmune-C induce tumor necrosis and recruitment of tumor infiltrating lymphocytes in cancerous lesions

Abstract

3077 Background: Rexin-G and Reximmune-C are pathotropic nanoparticles bearing a cytocidal cyclin G1 gene and a granulocyte- macrophage colony stimulating factor (GM-CSF) gene respectively. The purpose of the Phase I study is to evaluate the safety and therapeutic potential of i.v. infusions of Rexin-G followed by Reximmune-C, in an effort to achieve a personalized cancer vaccination in vivo in patients with chemo-resistant solid tumors. Methods: Seven patients received Rexin-G i.v. at a dose of 4 x 10e10 cfu per day for 2 -6 weeks followed by Reximmune-C i.v. at 2.5 x 10e9 cfu or 5 x 10e10 cfu per day for 2 to 5 days (Cumulative Dose: 1.00 -1.25 x 10e10 cfu). Results: There was no dose-limiting toxicity noted and GM-CSF protein was NOT detected in serum samples obtained during and after treatment with Reximmune-C. Immunologic reactions consisted of flu-like symptoms in two patients, redness and swelling of tumor-infiltrated cervical lymph node and metastatic chest nodule in two patients, swelling and acu...