FEASIBLITY ANALYSIS OF A CLINICAL ELECTROPORATION SYSTEM

DESCRIPTION (Provided by Applicant):The primary goal of the project is the development of automated equipment suitable for the clinical application of Electroporation Therapy (EPT). This system will provide the foundation for clinical implementation of Ichor's proprietary therapy, which has shown promise for treatment of solid tumors in the pancreas, head & neck, liver, and brain. Preclinical studies performed by Ichor confirmed data reported in the literature characterize the cytotoxic effects of EPT. However, these studies also suggest that, unlike traditional EPT approaches, unique features of this therapy make it highly selective for malignant cells. Thus, the technology potentially offers a method of treatment for locally advanced tumors with margins that extend into surrounding tissues. Feasibility of the proposed EPT system will be established by designing, constructing, and testing a microprocessor-based switching apparatus. This system will directly control delivery of electroporation pulses to an electrode array implanted in the patient. Research will focus on the components, architecture, and control system best suited for safe application of the unique electrical signals characteristic of electroporation. After feasibility has been confirmed, integration of the switching apparatus with pulse generation and control means will provide an EPT system appropriate for multi-center clinical studies and eventual commercial use. PROPOSED COMMERCIAL APPLICATION: Electroporation Therapy with bleomycin (EPT-B) has potential as a locoregional treatment for both primary and secondary tumors. In both preclinical and early phase clinical studies, EPT-B has shown significant anti-tumor effect in a variety of tumor types. It appears that EPT-B could be clinically appropriate for several cancers including head & neck, pancreatic, liver, and brain. The proposed research will focus on the development of an Electroporation Therapy system appropriate for commercial clinical use.