Study Marks First Time Immunotherapy Delivered with Electroporation Will Be Evaluated for This Condition
SAN DIEGO, CA — July 9, 2012 — OncoSec Medical Inc. (OTCBB: ONCS), a company developing the advanced-stage OncoSec Medical System (OMS) ElectroOncology therapies to treat solid tumors, announces it has received Investigational Review Board (IRB) approval at the University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center for a Phase II clinical trial evaluating OncoSec’s OMS ElectroImmunotherapy for the treatment of cutaneous T-cell lymphoma. UCSF investigators are actively recruiting for this clinical trial.
A total of up to 27 patients with cutaneous T-cell lymphoma will be enrolled in this Phase II, single-arm, open-label multi-center study. The trial’s primary endpoint is to assess local and distant response rate following treatment of cutaneous T-cell lymphoma lesions (mycosis fungoides or Sezary patients) with a DNA-based cytokine coded for the immune stimulating agent interleukin-12 (DNA IL-12) and electroporation. One treatment cycle will consist of three treatments applied to up to four lesions on days one, five and eight with a maximum dose of 3.0 mg DNA IL-12 per treatment cycle. Patients with stable disease or better at three months will be eligible to receive a second treatment cycle. Additional treatment cycles at six, nine and 12 months can be applied if there is no evidence of disease progression or intolerability of the treatment, with a maximum of four cycles. Treatment response at untreated sites will be evaluated according to the standard modified SWAT definition. 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. The first patient has been enrolled and successfully completed their first treatment cycle.
“The initiation of this study will mark the first time patients suffering from cutaneous T-cell lymphoma will be treated with an immunotherapy delivered using electroporation,” said Punit Dhillon, President and CEO of OncoSec. “We are excited to be working with Dr. Weiyun Ai and a leading academic institution, UCSF, in this study.”
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.
Dr. Ai said, “There exists a substantial need for novel treatments for cutaneous T-cell lymphoma. The role of electroporation in enhancing the efficiency and/or the tolerability of various agents, such as DNA IL-12, can be delivered to patients is well worth studying.”
About Cutaneous T-Cell Lymphoma
Cutaneous T-cell lymphoma (CTCL) is a heterogeneous class of non-Hodgkin’s lymphoma, which is a type of cancer of the immune system, with the most common forms being mycosis fungoides (MF) and Sezary syndrome (SS). The malignant T cells in the body initially migrate to the skin, causing various lesions to appear. These lesions change the depth of skin penetration as the disease progresses, typically beginning as what appears to be a rash, which can be very itchy and eventually forming plaque tumors as well as spreading to other parts of the body other than skin. The incidence of CTCL in the United States is approximately 1,500 new cases per year.
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