OncoSec Medical Inc. Reports Positive Interim Efficacy Results From Phase IV Study of NeoPulse in Skin Cancer Patients
Published: Nov 14, 2012
SAN DIEGO, Nov. 14, 2012 /PRNewswire/ -- OncoSec Medical Inc. (OTCBB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumors, 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.
About OncoSec Medical Inc.
OncoSec Medical Inc. is a biopharmaceutical company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumor cancers. ImmunoPulse and NeoPulse therapies address an unmet medical need and represent a potential solution, for less invasive and less expensive therapies that are able to minimize detrimental effects resulting from currently available cancer treatments such as surgery, systemic chemotherapy or immunotherapy and other treatment alternatives. OncoSec Medical's core technology is based upon its proprietary use of an electroporation platform to dramatically enhance the delivery and uptake of a locally delivered DNA-based immunocytokine (ImmunoPulse) or chemotherapeutic agent (NeoPulse). Treatment of various solid cancers using these powerful and targeted anti-cancer agents has demonstrated selective destruction of cancerous cells while sparing healthy normal tissues during early and late stage clinical trials. OncoSec's clinical programs include three Phase II clinical trials for ImmunoPulse targeting lethal skin cancers. More information is available at http://www.oncosec.com/.
This press release contains forward looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such "forward looking statements." Forward looking statements are based on management's current preliminary expectations and are subject to risks and uncertainties which may cause our results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include our ability to raise additional funding, our ability to acquire, develop or commercialize new products, uncertainties inherent in pre-clinical studies and clinical trials, unexpected new data, safety and technical issues, competition and market conditions. These and additional risks and uncertainties are more fully described in OncoSec Medical's filings with the Securities and Exchange Commission. Undue reliance should not be placed on forward looking statements which speak only as of the date they are made. OncoSec Medical disclaims any obligation to update any forward looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
SOURCE OncoSec Medical Inc.