Treatment of Merkel Cell Carcinoma

The treatment of many cancer types can vary quite widely. Different cancers and stages denote slightly different methods of treatment. While the early stages of some cancers – especially skin cancer – can sometimes require only minor surgery, others can require highly damaging doses of radiation and chemotherapy. With immunotherapy, companies like OncoSec are hoping to increase the number of available cancer treatments that are less damaging to the body. One specific cancer that we’re targeting is Merkel cell carcinoma.

Merkel Cell Carcinoma Recap

While skin cancer is well-known and well-documented, in most communities, few people differentiate between the various types. Melanoma, basal cell carcinoma and squamous cell carcinoma are, unfortunately, quite prevalent (and on the rise). It is important to understand the risk factors and preventative measures for these cancer types. However, there is one rare type of skin cancer called Merkel cell carcinoma: a deadly type of skin cancer with a low survival rate that still has no approved, specialized treatment method.

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“.

Exclusive License Extends Patent Protection for ImmunoPulse Technology

SAN DIEGO – September 11, 2012 – OncoSec Medical Inc. (OTCBB: ONCS), a company developing its advanced-stage ImmunoPulse and NeoPulse therapies to treat solid tumor cancers, announced it has secured an exclusive license for specific patented technology from the University of South Florida Research Foundation (USFRF) relating to the delivery of gene-based therapeutics via intratumoral and intramuscular electroporation. This patent is directly related to the ongoing Phase II trials for metastatic melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma using the company’s ImmunoPulse therapy, and extends patent protection for the ImmunoPulse technology to the year 2024. Financial terms of this agreement were not disclosed.

OncoSec’s proprietary gene and drug delivery platform, the OncoSec Medical System (OMS) electroporation device, is currently being used to develop the company’s ImmunoPulse and NeoPulse therapies. This platform encompasses patents, technology and other intellectual property for intratumoral methods for delivering drugs and gene-based treatments in humans.

ImmunoPulse involves the application of a brief electric field to the surface of the skin. This temporarily opens pores in the cell membrane, allowing anti-cancer agent DNA IL-12, to be absorbed more efficiently. DNA IL-12, which normally has difficulty penetrating the tumor cell membrane to get inside these cells, has been shown to significantly stimulate the immune system’s T-cells to fight the cancer. The new license from USFRF complements OncoSec’s seminal patents, particularly for the protection of the methods involved in the ImmunoPulse treatment, and specifically for the use of DNA IL-12.

“Our licensing agreement with the USFRF significantly strengthens OncoSec’s intellectual property rights in the area of gene and drug delivery via in vivo electroporation,” said Punit Dhillon, OncoSec’s President and CEO. “We anticipate that the further development of this technology will enhance the ability of ImmunoPulse to address the serious unmet need among patients with skin cancer. OncoSec’s patent portfolio places us in a preeminent position within the field of electroporation-based delivery of gene-based treatments for cancer.”

“OncoSec is the ideal choice to further develop this technology that I and my colleagues pioneered while working at the University of South Florida, and I am pleased they have secured this license,” said Richard Heller, Ph.D., author of the patented technology. “The technology involves short-pulsed electric fields that can deliver plasmid DNA to stimulate the immune system. As a result, it is a natural fit with OncoSec’s ongoing program to develop its ImmunoPulse therapy.”

 

 

SAN DIEGO – September 5, 2012 – OncoSec Medical Inc. (OTCBB: ONCS), a company developing its advanced-stage ImmunoPulse and NeoPulse technologies to treat solid tumor cancers, received a new Method of Use and Device patent (Patent Application No. 200780014313.0, “Method and Device for Treating Microscopic Residual Tumors Remaining in Tissues Following Surgical Resection”) for the OncoSec Medical System (OMS) electroporation device platform from the State Intellectual Property Office of the People’s Republic of China. The issuance of this patent has the potential to expand OncoSec’s commercial opportunities for minimally invasive and surgical procedures to treat solid tumors in a very large market such as China.

Punit Dhillon, OncoSec’s President and CEO, commented, “The issuance of this patent is significant, because the Chinese authorities have given the company patent approval for our claims regarding the OMS electroporation device itself, as well as the method of use. These are broad claims, wherein OncoSec now has the ability to deliver various therapeutic agents through its electroporation device, including bleomycin and DNA IL-12, as well as to treat tumors with these agents following surgical resection. Thus, this patent will act as a part of the company’s core strategy as we continue to develop and build our commercialization strategy in China, one of the largest emerging oncology markets.”

Numerous research studies have concluded that cancer has now become a leading cause of mortality in China, representing 25 percent of all deaths in urban areas and 21 percent in rural areas. Moreover, cancer mortality in China has been increasing rapidly and continuously during the past three decades, which indicates a significant need for novel therapies.

ImmunoPulse and NeoPulse are investigational therapies being evaluated to reduce the rate of cancer recurrence while minimizing quality-of-life side effects. These therapeutic approaches, as potential adjuncts to surgery, involve injecting the tumor with an anti-cancer agent, followed by electroporation to open up the cell membrane, which helps significantly increase the uptake of the agent. This approach has been shown to selectively kill cancer cells that may exist in the neighboring tissue, which may result in a reduced rate of recurrence and has the potential to complement standard-of-care surgical procedures.

 


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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