Tuesday, 28 February 2012

OncoSec Medical doses first patient in phase 2 melanoma electroimmunotherapy trial

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 company said.
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 study.
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 added.
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 company said.
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.

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