Merkel Cell Carcinoma Interim Data Announcement

OncoSec is continuing to execute on its corporate milestones, which were laid out for our investors at the beginning of 2012. The fourth quarter of 2012 will mark an important achievement for OncoSec – the  announcement of preliminary data from our Phase II ImmunoPulse clinical trials, the first of which will be presented at this years annual meeting for the Society of Immunotherapy of Cancer (SITC) later this week. Here, we will be presenting data from 5 patients treated in our Merkel cell carcinoma (MCC) program. Merkel cell carcinoma is an aggressive cancer that starts in the skin and Merkel cells. If you’d like to know more about this cancer, you can read our previous blog post titled, “What is Merkel Cell Carcinoma“.

Merkel Cell Carcinoma

 

Cancer can be a very difficult subject for people. Whether it is a fear of the results or the technical nature of the medical field, cancer can elicit a very strong response from patients, professionals, and the public alike. For those at risk for cancer – as well as the general public – it is important to know how certain cancers work, where they come from, and how they can be treated. One lesser talked about cancer that has been experiencing a rapid increase in diagnoses is Merkel cell carcinoma (MCC).


UCSF Joins University of Washington To Become Second Site in Trial
 

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 established the University of California San Francisco (UCSF) as the second enrolling site for its Phase II Merkel cell carcinoma clinical trial (OMS-I110). UCSF investigators are actively recruiting patients for this clinical trial. OMS-I110 was initiated at the University of Washington in January 2012, and the first patient was dosed there on January 6, 2012.

A total of up to 15 patients with local and distant Merkel cell carcinoma will be enrolled in this Phase II, single-arm, open-label multi-center study. The trial’s primary endpoint is to assess the clinical and biologic effects of increased local expression of interleukin-12 (IL-12) protein in the tumor microenvironment following treatment with OMS ElectroImmunotherapy from baseline to two to four weeks after the first injection. It is anticipated that marked local expression of IL-12 in the tumor will induce an immunologic response in the tumor microenvironment, which may result in clinical benefit for the patient. Investigators at the University of Washington have received Investigational Review Board (IRB) approval and will continue recruitment for this clinical trial as the lead enrollment center.

“We are pleased to have established a clinical site at UCSF for our Merkel cell carcinoma trial that joins our previously established site at the University of Washington,” said Punit Dhillon, President and CEO of OncoSec. “We are excited to be working with Dr. Siegrid Yu and UCSF in this Merkel cell carcinoma study. This is the third clinical trial conducted at this academic institution, which includes our ongoing trials for patients with metastatic melanoma and cutaneous T-cell lymphoma.”

Dr. Siegrid Yu, principal investigator and dermatologic surgeon at the UCSF Dermatologic Surgery and Laser Center, said, “There is a potential for electroporation to enhance the efficiency with which agents such as IL-12 can be delivered to Merkel cell carcinoma patients. We are glad to be joining the University of Washington in a trial to gauge the efficacy of this technique.”

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.

About Merkel Cell Carcinoma

Merkel cell carcinoma is a rare and highly aggressive cancer, with approximately 1,500 new cases each year, in which malignant cancer cells develop on or just beneath the skin and in hair follicles. The majority of Merkel cell carcinomas appear to be caused in part by a virus, Merkel cell polyomavirus. If this cancer metastasizes to the lymph nodes, the five-year survival rate is about 50 percent. A patient with a small tumor (less than 2 cm) that has not metastasized to the lymph nodes may have a five-year survival rate of more than 80 percent. Current treatment options for these patients is surgery, radiation and chemotherapy; however, up to half of patients suffer a recurrence. Rapid advances in the biology of this disease provide a strong rationale for immunotherapy of this virus-associated cancer.

 

 

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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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