OncoSec announces data from two Phase III trials of OMS ElectroChemotherapy for SCCHN

OncoSec Medical Inc. (OTCBB:ONCS), a company developing the advanced-stage OncoSec Medical System (OMS) ElectroOncology therapies to treat solid tumors, announced data from an interim analysis of two randomized Phase III clinical trials, HNBE-01 and HNBE-02, using electrochemotherapy to treat locally recurrent and second primary squamous cell carcinoma of the head and neck (SCCHN). The data are being presented July 22-24 at the 8th International Conference on Head and Neck Cancer in Toronto, Canada. 

In these studies, electrochemotherapy was compared against surgery for quality of life, safety, survival and local control at eight months, where local control is defined as destruction of the treated tumor without evidence of reappearance of the tumor at the treatment site. The data show OMS ElectroChemotherapy achieved the primary endpoint of preserving quality of life compared to surgery, and appears to be safe and comparable to surgery in achieving control in locally recurrent or second primary SCCHN. This therapy represents a viable alternative to potentially major surgical interventions for this patient population, where recurrent tumors in SCCHN usually have a poor prognosis with a local control rate of 40-50 percent and frequently associated loss of organ function.

Paul Goldfarb, M.D., Consulting Medical Director of OncoSec overseeing the Phase III studies, said, "Despite the early termination of this study, delayed interim analysis of these data clearly demonstrated there was equivalence in safety, local control at eight months and survival between electrochemotherapy and surgery, with a benefit of quality of life and function for patients who received electrochemotherapy." 

OncoSec is evaluating the regulatory strategy alternatives for the most optimal path to market clearance based on the available Phase III and previously announced Phase IV data. Concurrently, the company is seeking partnering opportunities as it begins to approach the FDA and other regulatory bodies with product registration plans.

Punit Dhillon, President and CEO of OncoSec, said, "Interim analysis of these two Phase III studies, and the recently released data from the Phase IV study carried out in Europe, has demonstrated that the primary endpoint of maintaining quality of life was achieved. In addition, OMS ElectroChemotherapy appears to provide a potentially important treatment alternative to surgery that may address hard-to-treat tumors where there exists a particular need to preserve function and quality of life. These data strongly support our partnering efforts for the OMS ElectroChemotherapy program."

SOURCE OncoSec Medical Inc.