SAN DIEGO, Feb. 28, 2012 /PRNewswire/ -- 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 will validate 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 stimulating agent 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.
Melanoma is the most serious form of skin cancer. If it is recognized and treated early, it is almost always curable, but if it is not, the cancer can advance and spread to other parts of the body, where it becomes hard to treat and can be fatal. While it is not the most common of the skin cancers, it causes the most deaths. The American Cancer Society estimates that at present, about 123,000 new cases of melanoma in the US are diagnosed in a year, resulting in approximately 10,000 deaths. Melanoma originates in melanocytes, the cells which produce the pigment melanin that colors our skin, hair, and eyes. The majority of melanomas are black or brown, but often they can also be skin-colored, pink, red, purple, blue or white. Currently, there remains few treatment options for patients with late stage metastatic disease that can extend survival for the broad population.
About OncoSec Medical Inc.
OncoSec Medical Incorporated is a biopharmaceutical company developing its advanced-stage OMS ElectroOncology therapies to treat solid tumor cancers 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 detrimental effects resulting from currently available cancer treatments such as surgery, systemic chemotherapy or immunotherapy and other treatment alternatives. OncoSec's core technology is based upon its proprietary use of an electroporation platform, the OncoSec Medical System (OMS), to dramatically enhance the delivery and uptake of a locally delivered DNA-based immuno-cytokine (OMS ElectroImmunotherapy) or chemotherapeutic agents (OMS ElectroChemotherapy). Treatment of various solid cancers using these powerful and 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. 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 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.
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