TARGETED GENE DELIVERY SIGNALS CANCER VACCINATION IN VIVO: Intravenous Infusions of Rexin-G Followed by Reximmune-C Induce Tumor Necrosis and Recruitment of Tumor Infiltrating Lymphocytes in Cancerous Lesions (...(x 10e9 cfu for 2 days (Cumulative Dose: ...),Health

Analysis of Safety showed that no dose-limiting toxicity was observed with this regimen, and immunoreactive GM-CSF protein was NOT detected in serum samples either during or after treatment with Reximmune-C. There was no significant alteration in hemodynamic function, bone marrow suppression, liver, kidney, or any other organ dysfunction related to the intervention. Immune-related reactions consisted of transient flu-like symptoms in two patients, redness and swelling of a tumor-infiltrated lymph node and one metastatic chest nodule, and acute flank pain in one patient with adrenal gland metastasis. Analysis of efficacy in biopsied tumor specimens revealed definitive expression of the GM-CSF transgene in cancer cells indicating effective gene delivery in vivo. Further, extensive tumor necrosis and tumor infiltrating lymphocytes (TILs) were observed within the tumors. Characterization of the recruited TILs showed CD35+ dendritic cells, CD8+ killer T cells, and CD138+ plasma B cells, with lesser amounts of CD68+ macrophages and CD20+ B cells, suggesting a relatively mature or advanced immune response. Taken together, this landmark study demonstrates (1) that the functionality of the gene delivery platform is profound; (2) the genetic constructs employed are relatively safe; and (3) the potential for a personalized cancer vaccination using this sequential gene transfer approach is now a realistic goal.

For more information about Rexin-G, Reximmune-C, on-going clinical trials in the USA and abroad, and/or Epeius pathotropic (disease-seeking) gene delivery systems, please contact Dr. Erlinda M. Gordon at egordon@epeiusbiotech.com.

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