Although the technique has shown promise, cytokine therapy has largely disappointed due to low response rates and high associated toxicity. Gene therapy based strategies for cytokine delivery have been proposed as a means improve the therapeutic and toxicologic effects of these immunomodulatory molecules. However, clinical implementation of this approach is hampered by the lack of a clinically viable gene delivery vector. Recent studies suggest that in vivo electroporation can dramatically improve the delivery of therapeutic agents into tumor tissue. Ichor has developed electroporation technology to enable the safe, effective, and reproducible clinical application of the therapy. The company is currently conducting a Phase I clinical study of electroporation mediated delivery of the drug bleomycin into pancreatic tumors. Initial preclinical work suggests that these same techniques can also dramatically improve the intratumoral delivery of nucleotide constructs. Ichor proposes to adapt its proprietary electroporation technology for the delivery of cytokine genes into tumor tissue. The scope of the proposed research includes rodent studies designed to establish effective treatment protocols and large animal toxicology and biodistribution studies. Successful completion of FLAIR Phase I will lead to clinical investigation of the therapy in patients with metastatic melanoma, to be conducted under FLAIR Phase II.
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