Cancer therapy company OncoSec Medical (OTCBB: ONCS) said Tuesday that it has dosed its first patient in a phase two clinical trial testing its OMS ElectroImmunotherapy treament on advanced-stage metastatic melanoma patients.
The dosing comes as the University of California San Francisco (UCSF)
received approval from the Investigational Review Board for the trial.
UCSF investigators are currently recruiting for this clinical trial, the
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 managed to outline a clinical development plan
for its local and potentially systemic ElectroImmunotherapy program,
which uses the OncoSec Medical System (OMS) to deliver a DNA-based
immunotherapy, known as DNA IL-12, designed to induce a local immune
response against the treated cancerous tumor, while exploiting this
response to initiate a global systemic response against untreated tumors
in other areas of the body.
"Results from our open-label Phase I study demonstrated that DNA
IL-12 and electroporation has the potential to establish a new standard
of care for the treatment of late-stage metastatic melanoma," said
president and CEO, Punit Dhillon.
"With immune response results from this Phase II study expected in
the second half of 2012, we are confident this study will validate the
value of OMS ElectoImmunotherapy."
So far, the company has decided to focus the development of the
ElectroImmunotherapy program on skin cancers, including three separate
indications for metastatic melanoma, cutaneous T-cell lymphoma and
merkel cell carcinoma. Phase two studies for each of these indications
are currently underway, with results from these trials expected in the
second half of the year.
For the metastatic melanoma trial, a total of up to 25 patients with
stage three or four cutaneous and in-transit metastatic melanoma will be
enrolled in the phase two, single-arm, open-label and multi-centre
The company said the trial is designed to assess local and distant
objective response following treatment of cutaneous melanoma lesions
with DNA IL-12 and electroporation, with a primary endpoint of 24 weeks.
One treatment cycle will consist of three treatments, applied to up
to four 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, OncoSec
OncoSec’s oncology assets related to its electroporation platform were licensed from Inovio Pharmaceuticals (AMEX:INO).
The electroporation method, which has proven to be both safe and well
tolerated, delivers cancer therapies through millisecond electric
pulses, raising cell uptake by up to 10,000 fold, allowing the
therapeutic agents to be more effective.
Phase one data using OMS ElectroImmunotherapy to treat malignant
melanoma showed that this therapy was both safe and well tolerated, the
In addition, 53 percent of patients with distant metastatic lesions
demonstrated an objective response, while 15 percent of these patients
having a complete response to the treatment.