Phase IV Study Demonstrates Local Tumor Control in 94% of Primary and 57% of Recurrent Tumors and Enhanced Quality of Life in Patients Treated with OMS ElectroChemotherapy
SAN DIEGO, CA, April 23, 2012 — OncoSec Medical Inc. (OTCBB:ONCS), which is developing its advanced-stage OncoSec Medical System (OMS) ElectroOncology therapies to treat solid tumors, today announced positive interim analysis of data from 81 subjects in a Phase IV study of primary and locally recurrent squamous cell carcinoma of the head and neck (HNSCC) treated with OMS ElectroChemotherapy in Europe. The study demonstrated the therapy’s ability to provide local tumor control and quality of life outcomes that compare favorably to standard outcomes associated with surgery. These results were presented at the 5th European Conference on Head and Neck Oncology in Poznan, Poland on Friday, April 20, 2012.
The primary goal of this phase IV head and neck cancer study was to assess the ability of the OMS ElectroChemotherapy to control growth or recurrence of the cancer eight months following treatment, equivalent to surgery as compared to historical controls, with respect to primary (new) tumors and locally recurrent tumors. In this interim analysis, local tumor control was achieved in 46/49 (94%) primary tumors and 12/21 (57%) recurrent tumors. This meant that there was no recurrence of the tumors during the monitoring period. These were excellent results that were on par with the expected outcomes of surgery. Furthermore, evaluation of safety using the OMS ElectroChemotherapy for this patient population demonstrated that the treatment was safe and well-tolerated with no grade three or higher adverse events related to treatment reported during this study.
In addition, the secondary endpoint of preservation of organ function and appearance using validated quality of life instruments demonstrated a positive outcome. The functional outcome measurement to evaluate quality of life assesses the ability to swallow, normalcy of diet, and ability to eat in public and is often assessed by the Performance Status Scale for Head and Neck cancer (PSSHN); general quality of life was assessed by the European Organization for Research and Treatment of Cancer Core QOL questionnaire (EORTC QLQ). Treated patients showed a mean overall score of 264 at baseline vs. 249 at eight months (p=0.3412), indicating no significant difference in quality of life following treatment with OMS ElectroChemotherapy. This is an excellent outcome; if the patient had been treated with surgery, the expectation and historical experience would result in a greater degradation of function and quality of life for these patients as determined by the PSSHN and EORTC QLQ scores. Therefore, treatment with OMS ElectroChemotherapy provided a significant benefit in maintaining quality of life while achieving an equivalent local control compared to surgery. Additional secondary endpoints for this study included evaluation of pharmacoeconomic factors (hospital costs, extent of medical interventions, and medication use) as well as clinical performance of the OncoSec Medical System and applicator. The conclusions regarding these endpoints were positive and will be reviewed in a final publication.
“There is a significant unmet clinical need for an alternative to surgery that selectively destroys cancer cells without harming normal healthy tissue,” said Dr. Paul Goldfarb, medical director of OncoSec and principal investigator of this study. “This therapy provides patients who would typically be subjected to disfiguring surgery with potentially improved treatment outcomes.”
Punit Dhillon, President and CEO, said, “Our OMS ElectroChemotherapy treatment provided safe and clinically beneficial outcomes for patients while maintaining quality of life. We strongly believe in the clinical relevance of the OMS ElectroChemotherapy program and believe these results will help prospective partners to better define the broad applicability and market opportunity for this novel treatment.”
This Phase IV pre-marketing study was conducted in 11 European clinical centers of excellence with institutional review board and competent authority approval and carried out under standard good clinical practices using OncoSec’s OMS ElectroChemotherapy treatment platform for primary and recurrent head and neck cancer.
About Head and Neck Cancer
Head and neck cancers are difficult to treat because of the damage to adjacent healthy tissue that occurs during surgical resection. Nevertheless, surgery is often the first treatment approach for a primary or first occurrence of a head and neck cancer if its size and location is amenable to this approach. Treatment may also involve radiation therapy where the tumor is either more difficult to access or complete removal is questionable. The recurrence rate of primary head and neck cancer following surgery has been reported to be as high as 50% depending on the size and location of the tumor using conventional therapy. There is consequently an urgent need for a treatment alternative with the ability to improve local tumor control, thereby reducing the rate of recurrence and improving survival. In addition, many patients treated with surgery and/ or radiation will experience problems associated with loss of function, such as swallowing and speech, and cosmetic disfigurement, significantly impacting quality of life for these patients. If a recurrence occurs, treatment may again involve surgery, radiation and/or chemotherapy. At this point, the goal of local tumor control is to maintain quality of life, and potentially salvage and cure the patient. The challenge is to achieve these goals while minimizing the injury to adjacent healthy tissue and maintaining quality of life and functional outcomes. Each year, there are approximately 150,000 new cases of head and neck cancer in Europe, resulting in 65,000 deaths. Worldwide, approximately 560,000 cases of head and neck cancer are diagnosed, and 300,000 patients are expected to die annually.
OncoSec’s ElectroChemotherapy enables local application of a chemotherapeutic agent, bleomycin, directly into a tumor and the healthy margin of tissue surrounding the tumor and selectively kills cancerous cells. As opposed to surgery, this therapeutic approach can avoid removal of healthy tissue, providing beneficial appearance, organ function and quality of life outcomes.
About OncoSec Medical Inc.
OncoSec Medical Incorporated (OTCBB: ONCS) develops novel OMS 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 therapieshave 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 for OMS ElectroImmunotherapy. More information is available at www.oncosec.com. Additional information may also be found at OncoSec’s Facebook , Twitter, and LinkedIn sites.
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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 ourresults 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.