SAN DIEGO, May 26, 2011 /PRNewswire/ -- OncoSec Medical Incorporated (OTCBB: ONCS), which is developing its advanced-stage ElectroOncology therapies to treat solid tumor cancers, announced today it will initiate three Phase II clinical trials to assess its cancer-destroying, tissue-sparing ElectroImmunotherapy technology in patients with melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma.
OncoSec's lead ElectroImmunotherapy candidate for these trials is a DNA plasmid coding for IL-12 that is delivered using electroporation. While the DNA IL-12 immunotherapy is administered locally, results from preclinical and Phase I trials indicated that the therapy was safe, without toxic side effects, and resulted in immune responses that produced both a local and systemic effect against abnormal cells. In the Phase I human study, 15% of patients demonstrated 100% clearance of distant, untreated metastatic melanoma tumors; only 0.25% would normally be expected to clear on their own if left untreated. If OncoSec's Phase II trials further validate this evidence, the DNA-based IL-12 ElectroImmunotherapy platform would represent an important advancement in the treatment of both local and metastatic cancers.
Punit Dhillon, OncoSec's President and CEO, said, "OncoSec is moving aggressively into three Phase II trials to evaluate our ElectroImmunotherapy platform using DNA IL-12 to activate both innate and adaptive immune responses to kill cancer cells. We are leveraging an experienced management team, a board of directors composed of recognized business and medical leaders, and a group of internationally eminent scientific researchers as advisors. We look forward to these next steps toward our goal of establishing a broad development pipeline for our ElectroImmunotherapy program and improving the quality of life of patients suffering from the life-altering effects of cancer."
All three of OncoSec's Phase II clinical trials will be open label, multi-center trials.
Phase II MelanomaTrial (OMS-I100)
OncoSec's melanoma trial, entitled "Phase II trial of intratumoral pIL-12 electroporation in advanced stage cutaneous and in transit malignant melanoma," will be a single dose trial treating approximately 25 patients. The primary endpoint is the objective response rate (local and distant) at six months. Secondary trial endpoints include time to objective response (complete and partial responses), duration of distant response and overall survival. OncoSec is building on positive Phase I dose escalation trial results in 24 patients with metastatic melanoma treated with DNA IL-12 in conjunction with electroporation. That study established safety and tolerability and suggested a systemic objective response in more than half of the subjects; 15% of patients showed 100% clearance of distant, non-treated tumors. Based on historical data, less than 1% of patients would have been expected to see regression in their untreated tumors.
According to the National Cancer Institute, about 70,000 new cases of melanoma are diagnosed each year in the U.S., with an estimated 9,000 deaths annually resulting from this most-widespread cancer. About 850,000 patients are currently afflicted with melanoma in the U.S. Current outcomes for melanoma treated by chemotherapy alone have shown a modest response of short duration; current clinical results for chemotherapy in combination with biologic agents have not proved encouraging due to high toxicity.
OncoSec's melanoma study is a physician-sponsored trial and will be initiated at the University of California at San Francisco.
Phase II Merkel Cell Carcinoma Trial (OMS-I110)
Merkel cell carcinoma is a lethal but rare skin cancer affecting about 1,500 people each year with 33% mortality rate. Current outcomes to chemotherapy treatment have demonstrated short-lived responses with no clear impact on overall survival. OncoSec's clinical trial, entitled "A Phase II study of intratumoral injection of interleukin-12 plasmid and in vivo electroporation in patients with Merkel cell carcinoma," is a single dose, open label trial in 15 patients. The study's endpoint is DNA IL-12 gene expression in tumor tissue at three to four weeks post-treatment. Secondary endpoints will evaluate objective response rates, time to relapse or progression and overall survival. This study will evaluate the safety and tolerability of DNA IL-12 as a treatment for Merkel cell carcinoma and aims to further validate the findings of the previously referenced Phase I trial in metastatic melanoma patients.
OncoSec's Merkel cell carcinoma study is a physician-sponsored trial and will be initiated at the University of California at San Francisco and University of Washington.
Phase II Cutaneous T-Cell Lymphoma (OMS-I120)
OncoSec's ElectroImmunotherapy is a potential new treatment for patients suffering from cutaneous T-cell lymphoma, or CTCL. This rare disease affects about 3,000 people each year. Today's systemically delivered treatment methods typically result in systemic toxicities that preclude their long-term use of this chronic life-altering disease. Cytokine therapies have shown excellent therapeutic benefit; unfortunately, one of the more promising cytokines, IL-12, results in unwanted toxicity and induces drug resistance with chronic use. OncoSec's ElectroImmunotherapy will locally deliver lowdose DNAIL-12 into the body with the goal of avoiding toxicity while inducing a systemic immune response capable of destroying cancerous cells.
OncoSec's clinical trial, entitled "Phase II trial of intratumoral IL-12 plasmid electroporation in cutaneous lymphoma," will be an open label, multi-center study and is expected to enroll at least 27 patients. The trial's primary endpoint is to assess the objective response rate (both local and distant),with safety and progression-free survival as secondary endpoint measures. The aim for this clinical trial is to provide evidence of the potent immune stimulating effects of OncoSec's ElectroImmunotherapy treatment using DNA IL-12 and its ability to improve the quality of life for patients suffering from the debilitating effects of cancer.
OncoSec's CTCL study is a physician-sponsored trial and will be initiated at the University of California at San Francisco and University of Pennsylvania.
Eminent Scientific Advisory Panel
To guide and evaluate these trials, OncoSec has attracted nine senior and respected oncology researchers to provide counsel as part of the company's scientific advisory panel for its ElectroImmunotherapy clinical program.
Alain Rook, M.D., Director of the Cutaneous Lymphoma Program at the University of Pennsylvania, said: "OncoSec and its novel ElectroImmunotherapy platform can be included in the recent coming-of-age for novel immunotherapy treatments demonstrated by the recent approval of Provenge, Ipilumimab and new agents on the horizon such as cancer metabolism and cancer stem cells."
The full panel consists of:
- WEI AI, M.D., PH.D., is an oncologist specializing in lymphoma and bone marrow transplant. Her research focuses on developing effective vaccine treatments and other novel therapeutics for lymphoma, including skin lymphoma. Dr. Ai is an assistant clinical professor in the UCSF Division of Hematology and Oncology.
- SHAILENDER BHATIA, M.D., is an Assistant Professor in the Department of Medicine at University of Washington. He completed his fellowship training in Medical Oncology at the University of Washington/Fred Hutchinson Cancer Research Center. His research efforts are focused on clinical and translational research in skin cancers (melanoma and Merkel cell carcinoma).
- ADIL DAUD, M.D., is widely recognized for his efforts in cancer clinical trials and he has pioneered several novel therapies for melanoma. He did his medical oncology fellowship training at Memorial Sloan Kettering Cancer Center in New York City and then moved to Moffitt Cancer Center, where he conducted the first human trial of DNA IL-12 with electroporation in patients with melanoma.
- RICHARD HELLER, PH.D., Director, Frank Reidy Research Center for Bioelectrics, Old Dominion University, is developing in vivo delivery procedures for non-viral gene therapy. His approach utilizes pulsed electric fields to facilitate targeting and uptake of delivered molecules.
- IACOB MATHIESEN, PH.D. has been a pioneer in the advancement of novel electroporation methods and devices for DNA delivery. He co-founded Inovio AS in 1999, a research and development company, which pursued advancements in the field of electroporation-based DNA delivery and was successful in securing pivotal patents, developing leading edge devices, and securing strategic partnerships.
- PAUL NGHIEM, M.D., specializes in skin cancers, with a particular interest in optimizing the management of patients with Merkel cell carcinoma (MCC). He has cared for over 300 patients with MCC and has lectured and written about this rare and challenging disease. Dr. Nghiem conducts basic science research on cancer biology at the University of Washington and Fred Hutchinson Cancer Research Center in Seattle.
- CHRISTIAN OTTENSMEIER, M.D., is one of the UK's leading researchers in cancer vaccines. He and his team are investigating how to stimulate the body's own immune system to recognize and kill cancer cells. The technique could be used in future treatments for cancers such as lymphoma and myeloma but also solid cancers such as bowel, lung or prostate.
- ALAIN ROOK, M.D. is an internationally recognized dermatologist and a leader in the research and development of novel therapies for cutaneous T-cell lymphoma (CTCL). As Director of the Cutaneous Lymphoma Program at the University of Pennsylvania he oversees one of the largest referral programs in the United States with more than 400 new CTCL referrals and nearly 2,000 total CTCL visits annually.
- DAVID WEINER, PH.D. is a world-renowned leader in immunology as well as gene vaccines and therapy. As a pioneer in the field of DNA vaccines, he has over 300 peer-reviewed publications in scientific journals to his credit and publication in mainstream scientific journals such as Scientific American. Dr. Weiner has been selected by the Institute for Scientific Information as one of the top cited scientists in the world.
About OncoSec's ElectroImmunotherapy and Electroporation Delivery
OncoSec's ElectroImmunotherapy consists of a DNA-based cytokine delivered using electroporation. Consisting of a DNA plasmid (manufactured circles of DNA) coded to produce a specific cytokine such as IL-12, this DNA immunotherapeutic is injected into locally targeted tumors and surrounding tissue and followed by electroporation. This results in significant uptake of the agent by cells in this area of tissue. The DNA plasmid instructs these cells to "express" the protein it was designed to produce, such as IL-12. After the immune system detects the immunotherapeutic agent, it produces significant amounts of immune agents such as macrophages and killer T-cells that are able to kill cancerous cells.
Cytokine immunotherapeutics such as IL-12 have been directly injected in the form of proteins and have been shown to induce innate immune system responses capable of killing cancerous cells. Unfortunately they can also cause toxic side effects as the immune system perceives the proteins to be foreign. When DNA IL-12 is injected, the IL-12 produced by the body does not induce this unwanted immune response but has been shown to induce an immune response against cancer cells.
In these Phase II trials OncoSec will employ its in vivo electroporation device, or OncoSec Medical System (OMS),to enhance the potency of the DNA IL-12. The OMS consists of a pulse generator and handheld applicator with a sterile disposable array. The system delivers nano-second electrical pulses that increase cell membrane permeability, resulting in significant cellular uptake of the DNA plasmid and subsequent gene expression (i.e. production of the coded antigen). OMS can increase gene expression by 1000-fold and immune responses by 100 times or more compared to an un-enhanced delivery of a DNA plasmid.
About OncoSec Medical Inc.
Oncosec Medical (OTCBB: ONCS) develops novel 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 therapies have 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. More information is available at www.oncosec.com.
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.
SOURCE OncoSec Medical Incorporated