OncoSec Medical Inc. announced positive interim results from a Phase IV trial investigating the use of NeoPulse in skin cancer patients at the 6th World Meeting of Interdisciplinary Melanoma/Skin Care Centres & 8th EADO Congress. Data from the trial showed a complete response of greater than 90 percent in basal cell carcinoma patients and 70 percent in squamous cell carcinoma patients at six months.
The data was presented in a poster titled “Interim analysis of an open-labeled, single-arm multicenter study of electrochemotherapy in skin cancer” by lead author Paul Goldfarb, M.D., and coauthors Lennart Lofgren, M.D., Ph.D., Axel Hauschild, M.D. and Richard Heller, Ph.D.
Dr. Hauschild said, “Based on these interim results, NeoPulse appears to provide local control with the potential advantage of preserving normal tissue, and therefore warrants further exploration as an alternative or even adjuvant treatment in cutaneous skin cancers.” Dr. Hauschild is a dermato-oncologist and professor of dermatology at the University of Kiel, Germany, and faculty member of the 6th World Meeting of Interdisciplinary Melanoma/Skin Care Centres & 8th EADO Congress.
The primary goal of this phase IV cutaneous cancer study was to assess the ability of NeoPulse to control growth or recurrence of the cancer six months following treatment, equivalent to surgery as compared to historical controls, with respect to primary (new) tumors and locally recurrent tumors. The study was conducted at 15 clinical centers across Western Europe. A total of 88 patients were enrolled and received treatment. At the time of analysis, 69 of 88 (78.4 percent) patients were evaluable at the six-month follow-up. The complete response rate at six months among basal cell carcinomas was 92.8 percent and 70 percent among squamous cell carcinomas. Response rate of melanoma was not calculated since multiple tumors were treated with concomitant therapy. The treatment was well-tolerated. The most frequent treatment-related adverse events were pain, infection and insomnia; all were transient and manageable.
NeoPulse appears well-tolerated and able to achieve local control comparable to that of surgical resection. The potential advantage of the therapy lies with the preservation of normal tissue with improved cosmesis, avoiding the need for reconstruction in difficult-to-treat sites or those with significant innervation. Together with the possible reduction in cost associated with hospitalization for procedures involving extensive reconstruction, the approach warrants further exploration as an alternative in select cases of skin cancer.
Punit Dhillon, President and CEO of OncoSec Medical, said, “These data demonstrate how NeoPulse might serve as an alternative to surgery that selectively destroys cancer cells without harming normal, healthy tissue. The results of OncoSec’s skin cancer program have so far shown a positive outcome among the class of patients who would typically be subjected to disfiguring surgery. We believe that NeoPulse offers a potentially significant new treatment for a variety of skin cancers.”
About the Phase IV Study
This Phase IV study was designed as an open-labeled study to measure local control and pharmacoeconomic parameters for NeoPulse in primary or recurrent squamous cell carcinoma of the skin, basal cell carcinoma as well as recurrent metastatic melanoma. Patients with primary or recurrent histologically confirmed tumors with no evidence of brain mestastases were eligible for enrollment. Safety and local control were measured. Patients received local injection of bleomycin followed by electroporation. Concomitant therapy was permitted when warranted.
Surgical resection of skin cancers can pose significant challenges in achieving local control while preserving normal tissue and function without the risk of cosmetic damage. NeoPulse involves the combined use of electroporation with intratumoral injection of low-dose bleomycin to treat local tumors. An evaluation of the pharmacoeconomic benefits of NeoPulse therapy suggests it could afford healthcare savings in reducing the expense and complications of reconstructive surgery to address cosmesis.