Final Trial Data Expected in 6-12 Months
SAN DIEGO – June 18, 2013 — OncoSec Medical Inc. (OTCQB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumor cancers, announced the completion of patient enrollment in a Phase II clinical trial of ImmunoPulse for metastatic melanoma patients.
The Phase II trial is evaluating efficacy of ImmunoPulse in subjects with Stage IIIb to IVa in-transit cutaneous metastatic melanoma with a primary endpoint of overall objective response (OOR) at 6 months as measured by modified RECIST. Secondary endpoints for this study will evaluate safety and tolerability, as well as local response of treated lesions at Day 90.
“We are pleased that our development milestones continue to meet our expectations. We have shown great adoption of ImmunoPulse with the clinical centers enrolling in this Phase II clinical trial for advanced-stage melanoma patients,” said Punit Dhillon, President and CEO of OncoSec Medical. “We are now interested in directing the focus to data analysis and the design of our next studies for the melanoma program, including expanding the adoption across other key centers of excellence.”
The ImmunoPulse trial is a single-arm, open-label and multicenter study. The trial is designed to assess local and distant response following treatment of cutaneous melanoma lesions with DNA IL-12 and electroporation with a primary endpoint of 24 weeks. One treatment cycle will consist of three treatments applied to up to four lesions on days 1, 5 and 8 with a maximum dose of 1.5 mg DNA IL-12 per treatment cycle. At 12 months, patients will be moved to the follow-up phase of the study and will be followed for up to five years for safety. This multicenter trial is being conducted in the United States at the University of California San Francisco, the University of Washington and the John Wayne Cancer Institute.
Previously, OncoSec provided an interim safety analysis of 13 patients of its Phase II metastatic melanoma program. The results showed that 95 percent of evaluable treated lesions demonstrated a response at Day 39 and Day 90. In addition, two subjects who were evaluable for the primary endpoint of overall objective response at Day 180 both demonstrated a clinically relevant objective response as measured by RECIST. In March 2013, an update of interim data was announced demonstrating durability of response of treated lesions. These data showed that all melanoma lesions that demonstrated at least a partial or complete response to treatment with ImmunoPulse had a 68 percent and 45 percent durable response at three and six months, respectively.