OncoSec Medical Inc. (OTCBB:ONCS), a company developing the advanced-stage OncoSec Medical System (OMS) ElectroOncology therapies to treat solid tumors, announces it has established the University of California San Francisco (UCSF) as the second enrolling site for its Phase II Merkel cell carcinoma clinical trial (OMS-I110). UCSF investigators are actively recruiting patients for this clinical trial. OMS-I110 was initiated at the University of Washington in January 2012, and the first patient was dosed there on January 6, 2012.
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's primary endpoint is to assess the clinical and biologic effects of increased local expression of interleukin-12 (IL-12) protein in the tumor microenvironment following treatment with OMS ElectroImmunotherapy from baseline to two to four weeks after the first injection. 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 have received Investigational Review Board (IRB) approval and will continue recruitment for this clinical trial as the lead enrollment center.
"We are pleased to have established a clinical site at UCSF for our Merkel cell carcinoma trial that joins our previously established site at the University of Washington," said Punit Dhillon, President and CEO of OncoSec. "We are excited to be working with Dr. Siegrid Yu and UCSF in this Merkel cell carcinoma study. This is the third clinical trial conducted at this academic institution, which includes our ongoing trials for patients with metastatic melanoma and cutaneous T-cell lymphoma."
Dr. Siegrid Yu, principal investigator and dermatologic surgeon at the UCSF Dermatologic Surgery and Laser Center, said, "There is a potential for electroporation to enhance the efficiency with which agents such as IL-12 can be delivered to Merkel cell carcinoma patients. We are glad to be joining the University of Washington in a trial to gauge the efficacy of this technique."
OMS ElectroImmunotherapy utilizes OncoSec's proprietary technology to deliver a DNA-based cytokine coded for the immune stimulating agent interleukin-12 (DNA IL-12). The OncoSec Medical System (OMS) applies short electric impulses to the tumor, causing pores to open in the membrane of cancer cells, which 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 percent of patients with distant metastatic lesions demonstrated an objective response, with 16 percent of these patients having a complete response to the treatment.
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