Biopharmaceutical company OncoSec Medical has completed the enrolment of patients with Stage IIIb to IVa in-transit cutaneous metastatic melanoma into its Phase II trial of ImmunoPulse.
The single-arm, open-label and multicentre study is designed to assess the local and distant response subsequent to treatment of cutaneous melanoma lesions with DNA IL-12 and electroporation.
The study's primary endpoint is overall objective response (OOR) as measured by modified RECIST at six months, while secondary endpoints are safety and tolerability, in addition to local response of treated lesions at day 90.
OncoSec Medical president and CEO Punit Dhillon said the enrolment of advanced-stage melanoma patients in the Phase II clinical trial demonstrates a significant adoption of ImmunoPulse.
"We are now interested in directing the focus to data analysis and the design of our next studies for the melanoma programme, including expanding the adoption across other key centres of excellence," Dhillon added.
In the trial, one treatment cycle will consist of three treatments applied to up to four lesions on days one, five and eight with a maximum dose of 1.5mg DNA IL-12 per treatment cycle.
Following the shift of patients to the follow-up phase of the study at 12 months, the subjects will be assessed for safety for up to five years.
The final data from the multicentre trial, which is being conducted in the US at the University of California San Francisco, the University of Washington and the John Wayne Cancer Institute, is expected in six to 12 months.
A 13-patient interim safety analysis of Phase II metastatic melanoma programme showed that 95% of evaluable treated lesions demonstrated a response at day 39 and day 90.
Furthermore, an updated analysis data demonstrated that all melanoma lesions which responded either partially or completely to ImmunoPulse treatment, had a 68% and 45% durable response at three and six months, correspondingly.
Image: Lymph node with almost complete replacement by metastatic melanoma. The brown pigment is focal deposition of melanin. Photo courtesy of Gabriel Caponetti.