OncoSec Medical (OTCBB:ONCS) said Wednesday it has initiated two additional clinical sites for its phase two advanced melanoma trial, testing its OMS ElectroImmunotherapy treatment.
The company said the John Wayne Cancer Institute in Santa Monica,
California, and the Lakeland Comprehensive Cancer Center in Lakeland,
Florida have been initiated as enrolling sites, with investigators now
screening patients for the phase two metastatic melanoma study.
OncoSec uses its electroporation delivery system that applies cell
membrane stimulation to deliver immunotherapy or chemotherapy to treat a
range of cancerous tumour types.
The OMS electroporation system has proven to enhance cellular uptake,
effectively treating cancerous cells while sparing surrounding healthy
tissue cutting through the toxic side effects of current available
treatment options like chemotherapy and radiation.
In 2011, the company outlined a clinical development plan for its
local and potentially systemic ElectroImmunotherapy program, which uses
the OMS system to deliver a DNA-based immunotherapy, known as DNA IL-12.
DNA IL-12 IS designed to induce a local immune response against the
treated cancerous tumour, while exploiting this response to initiate a
global systemic response against untreated tumours in other areas of the
This ElectroImmunotherapy treatment is currently being tested in the phase two trial for metastatic melanoma.
are very pleased to have two respected investigators in melanoma
clinical research, Drs. Mark Faries and Manuel Molina joining our Phase
II clinical study," said president and CEO, Punit Dhillon.
"Both the John Wayne Cancer Institute and Lakeland Comprehensive
Cancer Center are state of the art clinical sites and represent
important centers of excellence that will add value to enrollment
targets and expertise by participating in the study."
Principal investigator at John Wayne, Dr. Faries, added: "We are
enthusiastic about OncoSec's OMS ElectroImmunotherapy treatment approach
for cutaneous, in-transit metastatic melanoma.
"The treatment is easy to administer and has the potential to provide patients an alternative therapy for this deadly disease."
Along with these two sites announced today, and the University of
California San Francisco, the company plans to initiate several
additional "centers of excellence with key opinion leaders in melanoma
clinical research for its metastatic melanoma phase II study".
In the phase two study, a total of up to 25 patients with stage three
or four metastatic melanoma will be enrolled in the trial, designed to
assess local and distant objective response following treatment, with a
primary endpoint of 24 weeks.
One treatment cycle will consist of three treatments applied to up to
four cancerous lesions on days 1, 5 and 8 with a maximum dose of 1.5 mg
DNA IL-12 per treatment cycle.
At 12 months, patients will be moved to the follow-up phase of the
study and will be followed for up to five years for safety, the company
Phase I data using OMS ElectroImmunotherapy to treat malignant
melanoma demonstrated that the treatment was safe and well tolerated. In
addition, 53 percent of patients with distant metastatic lesions
demonstrated an objective response, with 15 percent of these patients
having a complete response to the treatment, OncoSec said.
Melanoma is a serious form of skin cancer. If it is recognized and
treated early, it is almost always curable, but if it is not, the cancer
can advance and spread to other parts of the body, where it becomes
hard to treat and can be fatal.
The American Cancer Society estimates that at present, about 123,000
new cases of melanoma in the US are diagnosed in a year, resulting in
around 10,000 deaths.
Melanoma originates in melanocytes, the cells which produce the
pigment melanin that colors our skin, hair, and eyes. The majority of
melanomas are black or brown, but often they can also be skin-colored,
pink, red, purple, blue or white.