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Re: None

Friday, 09/30/2016 8:10:33 PM

Friday, September 30, 2016 8:10:33 PM

Post# of 48316
Accelerated Approval Trial Design of ImmunoPulse® IL-12 and Keytruda in Stage III/IV Melanoma
Multicenter Phase II Trial of intratumoral pIL-12 + electroporation in combination with pembrolizumab (Keytruda) in patients with Stage III/IV melanoma who are refractory to pembrolizumab treatment
Patients will be given pIL-12 every 6 weeks and pembrolizumab every 3 weeks - Primary Objective
– Overall response rate (ORR) by RECIST (1.1) during 24 weeks of treatment - Secondary Objectives
– Duration of response (DOR)
– Response rate by irRECIST V 1.1
– Median progression free survival (PFS)
– Median overall survival (OS)


This is information from Oncosec's latest investor presentation download for September.

I assume this is the registration trial.

This is a six month accelerated approval trial design so by the end of next year we could have an approval for Immunopulse IL-12 with keytruda.....maybe?