OncoSec – Positive Phase IV ElectroChemotherapy Clinical Data
OncoSec has continued to demonstrate a commitment to achieving our corporate milestones and confirming the company’s urgency for developing revolutionary targeted therapies using its proprietary electroporation delivery system, the OncoSec Medical System, or OMS. With our recent $7.75 million financing we are now poised to focus our resources on exceeding expectations and continuing to drive value from our novel OMS treatment platforms.
OMS ElectroChemotherapy: Targeted Ablation of Solid Tumor Cancers
Today, we announced positive data from our late-stage Phase IV pre-marketing study conducted in Europe at leading clinical centers of excellence using OncoSec’s OMS ElectroChemotherapy treatment platform for primary and recurrent squamous cell carcinoma of the head and neck (HNSCC). Click here for a full copy of the press release.
Interim analysis of this study indicated that the primary endpoint of 8-month local tumor control rate for primary and recurrent HNSCC was excellent with 46/49 (94%) and 12/21(57%) respectively. In addition, the secondary endpoint of preservation of organ function and appearance using established quality of life instruments demonstrated a positive outcome. The functional outcome measurement to evaluate quality of life, specifically any deterioration of swallowing function, normalcy of diet and eating in public was assessed by the subjective Performance Status Scale for Head and Neck cancer (PSSHN) and general QOL by the European Organization for Research and Treatment of Cancer Core QOL questionnaire (EORTC QLQ). HNSCC patients showed a mean overall score of 264 at baseline vs. 249 at 8 months (p=0.3412) indicating no significant difference in quality of life at 8 months following treatment with OMS ElectroChemotherapy, therefore providing an advantage in maintaining quality of life. 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 during this study.
Secondary endpoints evaluated for this trial included Pharmacoeconomic factors (hospital costs, extent of medical interventions, medication use) and performance of the OncoSec Medical System and applicator. This data is being summarized in combination with the above results for final publication.
The impressive quality of life outcomes in conjunction with strong local tumor control responses are significant: the majority of patients treated in this study had advanced complicated tumors and the only alternative therapy would have been extensive surgery, with potential post-operative radiotherapy. Surgery may have precipitated collateral damage to surrounding tissues and vital structures. While post-treatment care could repair some of this damage, it may also result in further quality of life, physical and emotional burden on the patient and significant additional treatment costs.
In addition to these clinical results, we are preparing to present data from our Phase III head and neck cancer study carried out in the United States. This study was a randomized trial comparing preservation of function status after either OMS ElectroChemotherapy or surgery in patients with locally recurrent or second primary squamous cell carcinoma of the head and neck. These results will be presented at:
The 8th International Head and Neck Cancer Conference
Toronto Convention Center
July 21-25, 2012
“Interim analysis of two randomized Phase 3 trials comparing electrochemotherapy to surgery in recurrent head and neck cancer”
OMS ElectroImmunotherapy: On-going Clinical Trials for Rare and Deadly Skin Cancers
Two Phase II clinical trials for metastatic melanoma and Merkel cell carcinoma are now underway, and several patients in both trials have already been dosed. We expect our third Phase II trial for cutaneous T-cell lymphoma to be initiated in the coming weeks. We expect enrollment for these trials to continue through 2012, however, preliminary results will be shared before the end of the year.
The media has picked up the enthusiasm for our clinical trials and technology with several news outlets covering stories about the company. Below is a sample of OncoSec’s recent news coverage:
San Diego Business Journal– The article, titled “OncoSec Inches Ahead on Skin Cancer Zapping Technology” discusses OncoSec’s development plan, highlighting the company’s OMS ElectroImmunotherapy program for the treatment of Merkel cell carcinoma, metastatic melanoma and cutaneous T-cell lymphoma. This article is only available online to subscribers of the San Diego Business Journal
The Journal- The article, titled “Fighting skin cancer with electroimmunotherapy,” outlines the rationale for the Phase II Merkel cell carcinoma study and describes the urgent need for a new therapy for this patient population.
Today’s Medical Developments– The article, titled “A Novel Delivery System,” details the components and processes governing use of the novel OncoSec Medical System (OMS) technology platform, which leverages electroporation technology to target tumors and deliver powerful cancer therapeutic agents without affecting surrounding healthy tissue.
Medical Device and Diagnostic Industry– The article titled “OncoSec Could Revolutionize Oncology Therapy,” details the company’s promising OMS ElectroOncology treatment platform, as well as the on-going Phase II clinical studies in metastatic melanoma and Merkel cell carcinoma.
If you have any questions about OncoSec or our current activities, please contact us at email@example.com. Thank you for your support.
President & CEO