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.
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”
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 firstname.lastname@example.org. Thank you for your support.
President & CEO
OncoSec appoints three internationally recognized and respected medical innovators to its newly created Scientific Advisory Board (SAB).
This advisory board is established to provide input into the company’s R&D and clinical strategies, including OncoSec’s multiple planned Phase II clinical trials for the treatment of melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma.
Joining the SAB are: Richard Heller, Ph.D. – Director, Frank Reidy Research Center for Bioelectrics, Old Dominion University, Iacob Mathiesen, Ph.D. – CEO, Otivio AS, and Christian H. Ottensmeier, MD, Ph.D. – Professor of Experimental Cancer Research at the University of Southampton.
OncoSec enters into a collaborative research agreement with Serametrix Corporation to analyze subjects in three OncoSec Phase II clinical trials treating melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma. The goal of this research is to identify biomarkers that may refine and enhance the selection of patients potentially responsive to these treatments.
OncoSec submits the Device Master File (DMF) for its patented OncoSec Medical System (OMS) to the U.S. Food and Drug Administration (FDA).
The device consists of a generator and hand-held applicator designed to deliver DNA-based cytokines and chemotherapeutic agents for the treatment of solid tumor cancers. Numerous Phase I through Phase IV clinical trials have demonstrated the safe effective use of the device in optimizing cellular uptake of DNA based cytokines or chemotherapeutic agents resulting in improved therapeutic benefits for the patient.
After establishing engineering and manufacturing capabilities, transferring and updating regulatory, design, and manufacturing documentation, and implementing a new quality assurance system, the OncoSec Medical System (OMS) devices are released for shipment to clinical sites in time for the upcoming OMS clinical trials.
The company now has inventory of OMS investigational devices adequate to support known and anticipated clinical study requirements well into 2013.
OncoSec announces positive results for Phase IV head and neck cancer and Phase I breast cancer trials using its electroporation technology.
The FDA-approved Phase I breast cancer study of 13 patients with recurrent breast cancer treated with OncoSec’s OMS system demonstrates that the therapy was safe, well-tolerated, and achieved a 75% complete tumor response rate.
The Phase IV head and neck cancer trial is carried out in Europe and enrolls 92 patients (53 males and 39 females) with 66 patients followed for up to two years. Patient survival following treatment at 8 months was 95% (87/92) and 86% (79/92) at 24 months with, 83% (19/23) of patients with primary tumors being disease free at 8 months after treatment with bleomycin and electroporation alone .
OncoSec expands its engineering team to accelerate development of its proprietary cancer therapeutic delivery device. Brian McCluskey is appointed as executive director, engineering, and is tasked with leading the development of the company’s proprietary technology.
Mr. McCluskey brings more than 30 years of electrical engineering experience to OncoSec, including 20 years of experience in software and hardware for medical and research devices. Mr. McCluskey worked for a number of leading medical device companies including Digirad Corporation, Teledyne RD Instruments and Smith & Nephew Inc.
OncoSec closes the sale to institutional investors of an aggregate of 4,000,000 shares of its common stock at $0.75 per share in a private placement. The gross proceeds of the offering are $3 million, and net proceeds come to approximately $2.79 million. OncoSec intends to use proceeds from the offering for further development of its electroporation therapies to treat cancers, clinical studies, and general corporate purposes.
OncoSec announces two appointments to its clinical team: Dr. Paul Goldfarb and Ernest Kitt.
Dr. Paul Goldfarb assumes the role of medical director, advising the Company’s clinical and regulatory affairs department on all clinical programs. Dr. Goldfarb brings more than 40 years of expertise as a surgical oncologist and practicing physician. He is also the author of numerous peer-reviewed articles related to the use of electroporation to deliver bleomycin in solid tumors and other ablative technologies for the treatment of cancer
Ernest Kitt becomes executive director, clinical operations. He brings 15 years of industry experience in clinical research and operations, including the management of early and late stage oncology programs for established biotechnology companies including Medicinova and Vical.
Additional evaluation of a previous Phase I trial for electroporation shows systemic effects of metastatic melanoma tumor in more than 50% of patients. In this Phase I trial, the experimental regimen is shown to be safe and well tolerated, with minimal systemic toxicity. Local treated lesions are biopsied and show that 76% of all samples had at least 20% necrosis of the tumor, with 34% of those lesions showing 100% necrosis (clearance of the tumor).
These positive results are presented by Dr. Adil Daud, principal investigator of the study, at the ASCO 2011 Annual Meeting.