OncoSec Initiates Two Additional Clinical Sites for Phase II Metastatic Melanoma Trial
SAN DIEGO, March 14, 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 John Wayne Cancer Institute in Santa Monica, CA, and Lakeland Comprehensive Cancer Center in Lakeland, FL have been initiated as enrolling sites, and investigators are screening patients for the Phase II metastatic melanoma clinical trial (OMS-I100).
"We are very pleased to have two respected investigators in melanoma clinical research, Drs. Mark Faries and Manuel Molina joining our Phase II clinical study," said Punit Dhillon, President and CEO. "Both the John Wayne Cancer Institute and Lakeland Comprehensive Cancer Center are state of the art clinical sites and represent important centers of excellence that will add value to enrollment targets and expertise by participating in the study."
Dr. Faries, principal investigator at John Wayne Cancer Institute said, "We are enthusiastic about OncoSec's OMS ElectroImmunotherapy treatment approach for cutaneous, in-transit metastatic melanoma. The treatment is easy to administer and has the potential to provide patients an alternative therapy for this deadly disease."
Dr. Molina, principal investigator at Lakeland Comprehensive Cancer Center said, "Data from the Phase I study was very impressive, which demonstrated that the therapy was not only safe but also provided durable therapeutic benefit. Advancing into a Phase II study is encouraging and is important for validation of results seen in the Phase I study. We look forward to participating in this trial."
Along with these sites and the University of California San Francisco, the company plans to initiate several additional centers of excellence with key opinion leaders in melanoma clinical research for its metastatic melanoma phase II study.
About OncoSec's Metastatic Melanoma Phase II Study (OMS-I100)
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.
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