OncoSec Initiates Phase II Clinical Program in Cutaneous T-Cell Lymphoma and Doses First Patient
SAN DIEGO, July 9, 2012 /PRNewswire/ — 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.
About OncoSec Medical Inc.
OncoSec Medical Inc. is a biopharmaceutical company developing advanced-stage OMS ElectroOncology therapies to treat solid tumors and metastatic disease. OMS ElectroOncology therapies address an unmet medical need and represent a potential solution for less invasive and less expensive therapies that are able to minimize the detrimental effects resulting from traditional cancer treatments. OncoSec’s core technology is based upon its proprietary use of an electroporation platform, to dramatically enhance the delivery and uptake of a locally delivered DNA-based immuno-cytokine or a chemotherapeutic agent. Treatment of various solid cancers using these targeted anti-cancer agents has demonstrated selective destruction of cancerous cells while sparing healthy normal tissues during early and late stage clinical trials. OncoSec’s clinical programs include three Phase II clinical trials for OMS ElectroImmunotherapy targeting lethal skin cancers. More information is available at www.oncosec.com.
This press release contains forward looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward looking statements.” Forward looking statements are based on management’s current preliminary expectations and are subject to risks and uncertainties which may cause our results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include our ability to raise additional funding, our ability to acquire, develop or commercialize new products, uncertainties inherent in pre-clinical studies and clinical trials, unexpected new data, safety and technical issues, competition and market conditions. These and additional risks and uncertainties are more fully described in OncoSec’s filings with the Securities and Exchange Commission. Undue reliance should not be placed on forward looking statements which speak only as of the date they are made. OncoSec disclaims any obligation to update any forward looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
University of California Disclaimer: The information stated above was prepared by OncoSec Medical Incorporated and reflects solely the opinion of the corporation. Nothing in this statement shall be construed to imply any support or endorsement of OncoSec, or any of its products, by The Regents of the University of California, its officers, agents and employees.
SOURCE OncoSec Medical Incorporated