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news.US-based OncoSec Medical has reported positive top-line six-month results from the first Phase II trial of its investigational intratumoral plasmid IL-12 electroporation (pIL-12 EP) monotherapy (ImmunoPulse IL-12) to treat patients with stage III and IV metastatic melanoma.
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During the trial, 30 patients with stage III-IV melanoma received about four cycles of pIL-12 EP into superficial cutaneous, subcutaneous and nodal lesions on days one, five and eight of each 12-week cycle.
The company said that tumor responses were evaluated using modified response evaluation criteria in solid tumors (RECIST) criteria for cutaneous lesions.
The trial’s primary endpoint was best overall response rate (bORR) by modified RECIST. The bORR was 31% in the 29 response-evaluable patients, with 14% of patients achieving a complete response (CR).
OncoSec chief medical officer Dr Mai Le said: "Along with the Phase I long-term survival analysis presented yesterday, these data continue to support the use of pIL-12 EP as a treatment for metastatic melanoma.
"Importantly, our observation that non-treated lesions regress in approximately half of the patients suggests that local, intratumoral pIL-12 EP successfully induces a more global anti-tumor immune-mediated response."
The company’s core technology is designed to improve the local delivery and uptake of DNA IL-12 and other DNA-based immune-targeting agents.