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news.Inovio Biomedical has announced that interim data from a first-in-man Phase I clinical trial demonstrated that a DNA-based immunotherapy against metastatic melanoma, delivered using the company's electroporation delivery technology, was safe and also produced durable local and systemic tumor regression.
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This investigator-sponsored Phase I clinical study was designed to assess safety, tolerability and clinical responses against metastatic melanoma after administration of plasmid-based IL-12 delivered intratumorally by Inovio’s electroporation system.
Twenty four patients were treated at seven escalating dose levels. Of 19 patients with both treated and untreated distal lesions, two (10%) showed complete regression of all lesions (including distal untreated lesions), suggesting a systemic effect of the therapy. Eight additional patients (42%) showed a systemic response resulting in stable disease or objective regression of untreated lesions. The experimental regimen was safe and well tolerated and no dose-limiting toxicity was noted.
Inovio’s electroporation delivery technology is intended to enhance the potency of DNA-based immunotherapies, including DNA vaccines, against cancers and infectious diseases.
Avtar Dhillon, president and CEO of Inovio, said: “We are now evaluating the possibility of a Phase II clinical study of this plasmid IL-12 immunotherapy using our DNA delivery technology.”