OncoSec ElectroChemotherapy Demonstrates Potential as Alternative to Surgery
OncoSec Medical Inc., which is developing its advanced-stage OncoSec Medical System (OMS) ElectroOncology therapies to treat solid tumors, recently 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
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 8 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 versus 249 at 8 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.
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.
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 significantly 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.
Total Page Views: 866
