Current treatment methods for unresectable primary liver tumors and liver metastasis from distant sites are inadequate. Investigation of novel treatment strategies is warranted due to the lack of effective therapy. ? ? In vivo electroporation has been shown to dramatically improve the uptake of therapeutic agents in targeted regions of tissue. During previous studies, Ichor investigated the anti-tumor and toxicological effects associated with electroporation mediated delivery of a chemotherapeutic agent. These studies, as well as subsequent experiments potentiating the intratumoral delivery of nucleic acids, demonstrate the basic merit of the approach. However, current methods and devices require an open surgical procedure for electroporation application. This is a critical limitation that could preclude widespread implementation of the approach. ? ? In light this limitation, Ichor proposes a Phase I study to develop an application system that can be applied in a minimally invasive fashion for the intratumoral delivery of therapeutic agents to hepatic tumors. The proposed scope of work includes research and development of functional prototypes including a pilot evaluation study in large animals. Successful completion of the proposed SBIR Phase I will result in a device suitable for use in a Phase II clinical study as well as out-licensing for use by strategic partners. ? ? ?
