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