OncoSec Medical (OTC:ONCS) said Monday that several patients have now been treated in an open label Phase 2 clinical trial evaluating OMS ElectroImmunotherapy in people with merkel cell carcinoma, a rare and aggressive skin cancer.
The electroimmunotherapy program 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.
The company's OMS system uses electroporation delivery to treat the cancer, which has proven to enhance cellular uptake, effectively treating cancerous cells while sparing surrounding healthy tissue - cutting through the toxic side effects of currently available treatment options like chemo and radiation.
The Phase 2 clinical trial is designed to test DNA IL-12 administered using OncoSec’s treatment approach for immunotherapy in patients with local and distant merkel cell carcinoma. A total of up to 15 patients will be enrolled in the single-arm, multi-centre study.
The trial will assess both clinical and biologic effects of increased local expression of the IL-12 protein in the tumour following treatment with OMS ElectroImmunotherapy.
OncoSec said the marked local expression of IL-12 will induce an immunologic response in the tumour, which may result in clinical benefit for the patient.
A number of patients have already been enrolled, with the first patient successfully finishing treatment on January 6.
"We were impressed by the results of the Phase I study in malignant melanoma patients and strongly believe that OMS ElectroImmunotherapy will be especially effective in an immunogenic cancer such as Merkel cell carcinoma," said Dr. Shailender Bhatia, lead investigator of the study.
OMS ElectroImmunotherapy uses OncoSec's proprietary technology to deliver a DNA-based cytokine coded for the immune stimulating agent interleukin-12, or DNA IL-12.
The OMS applies short electric impulses to the tumour, causing pores to open in the membrane of cancer cells that significantly increases DNA IL-12 uptake into these cells.
Phase I data revealed that using OMS ElectroImmunotherapy to treat malignant melanoma had been safe and well tolerated.
About 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’s chief executive, Punit Dhillon, said: "This new clinical study is the only active immunotherapy trial that is focused specifically on this disease."
Merkel cell carcinoma is a rare and highly aggressive cancer, with roughly 1,500 new cases each year, in which malignant cancer cells develop on or just beneath the skin and in hair follicles.
If the cancer metastasizes to the lymph nodes, the five-year survival rate is about 50 percent. A patient with a small tumour that has not metastasized may have a five-year survival rate of over 80 percent.
Current treatment options for these patients include surgery, radiation and chemotherapy; however, up to half of patients suffer a recurrence.