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OncoSec Medical Inc Reports Positive Preliminary Efficacy Results from phase II Study Of ImmunoPulse In Metastatic Melanoma Patients


Thursday, 15 Nov 2012 06:02am EST 

OncoSec Medical Inc announced positive preliminary results from a Phase II trial investigating the use of ImmunoPulse in metastatic melanoma patients at the 6th World Meeting of Interdisciplinary Melanoma Skin Cancer Centres & 8th EADO Congress. This preliminary interim analysis of 13 out of 25 patients supports key findings from a Phase I trial suggesting that ImmunoPulse is able to induce regression or stabilization of distant untreated metastases following a single cycle of treatment. A total of up to 25 patients with stage III or IV cutaneous and in-transit metastatic melanoma will be enrolled in this Phase II, single-arm, open-label and multi-center study. The trial was designed to assess local and distant objective response following treatment of cutaneous melanoma lesions with ImmunoPulse. As per the protocol, a preliminary interim analysis was scheduled upon completion of 50% enrollment in the study. The purpose of the analysis was to confirm safety and efficacy observed in the Phase I study. At the time of this preliminary interim analysis, 13 patients were enrolled and treated. Thirteen subjects were evaluable at Day 39, nine at Day 90, and two at Day 180. 95% of treated lesions demonstrated response at Day 39 (5% progressive disease, 14% stable disease (SD), 42% partial response (PR), 39% complete response (CR)). All treated lesions at Day 90 (5% SD, 50% PR, 45% CR), and at Day 180 (33% PR, 67% CR) demonstrated a response. 

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