OncoSec shares rise on phase III study results for head and neck cancer

OncoSec Medical (OTCBB:ONCS) saw its shares rally more than 6 per cent Monday morning after announcing that its two phase III studies testing its OMS electrochemotherapy treatment for head and neck cancer showed "improved quality of life."

The data from an interim analysis are being presented July 22-24 at the 8th International Conference on Head and Neck Cancer in Toronto, Canada.

The trials, HNBE-01 and HNBE-02, tested the company's electrochemotherapy treatment for locally recurrent and second primary squamous cell carcinoma of the head and neck.

The OMS electrochemotherapy was compared against surgery for quality of life, safety, survival and local control at eight months. Local control is defined as the destruction of the treated tumor without evidence of reappearance at the treatment site.

According to OncoSec, the data showed the therapy achieved the main goal of the trial to preserve quality of life as compared to surgery, while appearing to be safe and comparable to surgery in terms of achieving local control.

OncoSec Medical System’s (OMS) treatment platform treats solid tumours and spared surrounding healthy tissue, avoiding the detrimental effects of current cancer treatments such as surgery, chemotherapy or immunotherapy.

OMS applies short electric impulses to the tumor, causing pores to open in the membrane of cancer cells, which significantly increases the uptake of the chemotherapy into these cells.

The company said the therapy represents a "viable alternative" to potentially major surgical interventions for the head and neck cancer population, where recurrent tumours usually have a poor prognosis, with a local control rate of 40 to 50 per cent and frequent loss of organ function.

"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," said president and CEO of OncoSec, Punit Dhillon.

"These data strongly support our partnering efforts for the OMS ElectroChemotherapy program."

OncoSec said it is evaluating the regulatory strategy alternatives for the best path to market clearance based on the available phase III and previously announced phase IV data.

At the same time, the company is seeking partnering opportunities as it begins to approach the FDA and other regulatory bodies with product registration plans.

"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," said consulting medical director for OncoSec, Paul Goldfarb, who is also overseeing the phase III studies.

The studies were designed as two open-label trials in which 214 patients were randomized 1:1 between surgery and electrochemotherapy. The primary endpoint of quality of life was measured by the Performance Status Scale for Head and Neck Cancer (PSSHN).

Secondary endpoints were safety, local control at eight months and survival.

The trials were conducted at 22 sites in the United States, Canada, Eastern and Western Europe.

The company said median time to death was "statistically indistinguishable", between surgery at 209 days versus 231 days for electrochemotherapy.

The interim analysis of long-term follow-up data at up to two years indicated there were no safety issues relating to electrochemotherapy, OncoSec added.

In 2007, the Data Montioring Committee overseeing the phase III studies recommended that enrollment be terminated early and the trials halted, citing concerns with efficacy and safety.

The treated patients were followed up to two years to further evaluate safety and efficacy, as per protocol, but no additional data analysis was performed until recently by OncoSec, it said.

Earlier this month, the cancer treatment specialist said it was to start phase II clinical trials for its rare skin cancer treatment at a second site.

A total of up to 15 patients with Merkel cell carcinoma, a rare and aggressive form of skin cancer, will be enrolled at the University of California San Francisco (UCSF) for the trials.
The phase II trial was initiated at the University of Washington in January. The study is assessing the effects of increased expression of the interleukin-12 (IL-12) protein in the tumor following treatment with OMS ElectroImmunotherapy.