OncoSec Initiates Phase II Merkel Cell Carcinoma Study and Doses Several Patients

Feb 13, 2012

AN DIEGO, Feb. 13, 2012 /PRNewswire via COMTEX/ -- OncoSec Medical Incorporated,ONCS +2.86% which is developing its advanced-stage OncoSec Medical System (OMS) ElectroOncology therapies to treat solid tumor cancers, today announced that physicians at the University of Washington and Seattle Cancer Care Alliance in conjunction with the Fred Hutchinson Cancer Center, have treated several patients in an open-label Phase II clinical trial evaluating OncoSec's OMS ElectroImmunotherapy for the treatment of Merkel cell carcinoma (MCC). The clinical trial is designed to test DNA IL-12 administered using OncoSec's novel treatment approach for immunotherapy (referred to as OMS ElectroImmunotherapy), in patients with local and distant Merkel cell carcinoma.

A total of up to 15 patients with local and distant Merkel cell carcinoma will be enrolled in this Phase II, single-arm, open-label, multi-center study. The trial is designed to assess the clinical and biologic effects of increased local expression of IL-12 protein in the tumor microenvironment following treatment with OMS ElectroImmunotherapy. It is anticipated that marked local expression of IL-12 in the tumor will induce an immunologic response in the tumor microenvironment, which may result in clinical benefit for the patient. Investigators at the University of Washington, a world leader in the treatment of Merkel cell carcinoma, have received Investigational Review Board (IRB) approval and will continue recruitment for this clinical trial as the lead enrollment center. Several patients have been enrolled with the first patient successfully completing treatment on January 6, 2012.

"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," commented Dr. Shailender Bhatia, principal investigator at the University of Washington. Dr. Paul Nghiem, co-investigator at the Fred Hutchinson cancer center, added, "Our clinical and research teams have been working with Merkel cell carcinoma for many years, and we are delighted that OncoSec is now taking the industry lead in developing a cancer immunotherapy for this deadly disease."

Punit Dhillon, President and CEO of OncoSec, said, "The University of Washington is a leading institution in the treatment and research of Merkel cell carcinoma, and patients with this rare and deadly skin cancer have few treatment options. This new clinical study is the only active immunotherapy trial that is focused specifically on this disease."

OMS ElectroImmunotherapy utilizes 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 tumor, causing pores to open in the membrane of cancer cells that significantly increases DNA IL-12 uptake into these cells. Phase I data using OMS ElectroImmunotherapy to treat malignant melanoma demonstrated that this therapy was safe and well tolerated. In addition, 53% of patients with distant metastatic lesions demonstrated an objective response, with 15% of these patients having a complete response to the treatment.

About Merkel Cell Carcinoma

Merkel cell carcinoma is a rare and highly aggressive cancer, with approximately 1,500 new cases each year, in which malignant cancer cells develop on or just beneath the skin and in hair follicles. The majority of Merkel cell carcinomas appear to be caused in part by a virus, Merkel cell polyomavirus. If this cancer metastasizes to the lymph nodes, the five-year survival rate is about 50 percent. A patient with a small tumor (less than 2 cm) that has not metastasized to the lymph nodes may have a five-year survival rate of more than 80 percent. The current treatment options for these patients are surgery, radiation and chemotherapy; however, up to half of patients suffer a recurrence. Rapid advances in the biology of this disease provide a strong rationale for immunotherapy of this virus-associated cancer.

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