Clinical Trial Designed to Validate Strong Safety and Efficacy Results Demonstrated in Phase I Study
SAN DIEGO, CA, February 28, 2012 — OncoSec Medical Incorporated (OTCBB: ONCS), which is developing its advanced-stage OncoSec Medical System (OMS) ElectroOncology therapies to treat solid tumor cancers, today announced that Investigational Review Board (IRB) approval has been received by the University of California San Francisco and the first patient has been dosed for a Phase II clinical trial evaluating OncoSec’s OMS ElectroImmunotherapy for the treatment of advanced stage cutaneous and in-transit metastatic melanoma. UCSF investigators are actively recruiting for this clinical trial.
“Results from our open-label Phase I study demonstrated that DNA IL-12 and electroporation has the potential to establish a new standard of care for the treatment of late-stage metastatic melanoma,” said Punit Dhillon, President and CEO of OncoSec. “With immune response results from this Phase II study expected in the second half of 2012, we are confident this study willvalidate the value of OMS ElectoImmunotherapy.”
A total of up to 25 patients with stage III or IV cutaneous and in-transit metastatic melanoma will be enrolled in this Phase II, single-arm, open-label and multi-center study. The trial is designed to assess local and distant objective response following treatment of cutaneous melanoma lesions with DNA IL-12 and electroporation with a primary endpoint of 24 weeks. One treatment cycle will consist of three treatments applied to up to four lesions on days 1, 5 and 8 with a maximum dose of 1.5 mg DNA IL-12 per treatment cycle. 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.
OMS ElectroImmunotherapy utilizes OncoSec’s proprietary technology to deliver a DNA-based cytokine coded for the immune stimulatingagent interleukin-12, or 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 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 OncoSec Medical Inc.
OncoSec Medical Incorporated (OTCBB: ONCS) develops novel OMS ElectroOncology therapies that combine its proprietary electroporation delivery technology with a chemotherapeutic or novel DNA-based immunotherapeutics. Targeted local delivery of these agents is designed to achieve selective destruction of cancerous tumors while sparing healthy normal tissue, resulting in improved functional, cosmetic and quality of life outcomes. These therapieshave achieved validating safety and efficacy data in early and late stage clinical studies of over 400 cancer patients. OncoSec’s clinical programs include three Phase II clinical trials for OMS ElectroImmunotherapy. More information is available at www.oncosec.com. Additional information may also be found at OncoSec’s Facebook , Twitter, and LinkedIn sites.
* * *
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 ourresults 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.