OncoSec Medical (OTCBB:ONCS) unveiled early Monday positive interim data from a phase IV trial testing its OMS (OncoSec Medical System) ElectroChemotherapy treatment in Europe.
The cancer therapy company uses its OMS electroporation delivery system that applies short electric pulses to cells, causing the opening of pores in the cell membrane, and allowing for the efficient and safe delivery of immunotherapy or chemotherapy agents to treat a range of solid tumour cancers.
The OMS electroporation system has proven to enhance cellular uptake, effectively treating cancerous cells while sparing surrounding healthy tissue cutting through the toxic side effects of current available treatment options like chemotherapy, radiation and surgery.
Today, the company announced interim analysis of data from 81 subjects in a phase IV study of patients with primary (new) and locally recurrent squamous cell carcinoma of the head and neck.
The patients were treated with OMS ElectroChemotherapy, with the study showing the therapy's ability to provide local tumour control and quality of life outcomes that "compared favourably" to standard outcomes associated with surgery, the company said.
"Our OMS ElectroChemotherapy treatment provided safe and clinically beneficial outcomes for patients while maintaining quality of life," said president and CEO Punit Dhillon in a statement.
"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."
The main goal of the phase IV head and neck cancer study was to assess the ability of the OMS ElectroChemotherapy to control growth or cancer recurrence eight months following treatment, equivalent to surgery as compared to historical controls with respect to new and locally recurrent tumours.
Head and neck cancers are typically difficult to treat because of the damage to adjacent healthy tissue that occurs during surgery, which could results in potentially disfiguring problems.
In the interim analysis, local tumor control was achieved in 46 of 49, or 94 percent, of primary tumors and 12 of 21, or 57 percent, of recurrent tumors.
The company said the results mean there was no recurrence of the tumours during the monitoring period.
"These were excellent results that were on par with the expected outcomes of surgery," the company said in a statement.
The treatment also showed its was both safe and well-tolerated, with no grade three or higher adverse events reported during the study.
The secondary endpoint of the trial was the preservation of organ function and appearance, using quality of life instruments.
The functional outcome measurement assesses the ability to swallow, normalcy of diet, and the 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).
The company said treated patients showed a mean overall score of 264 at baseline, versus 249 at eight months, indicating "no significant difference" in quality of life following treatment with OMS ElectroChemotherapy.
OncoSec noted that this is an "excellent" outcome compared to surgery, which typically results in a greater degradation of function and quality of life.
Other secondary goals for the study included the evaluation of pharmacoeconomic factors, such as hospital costs, extent of medical interventions and medication use, as well as clinical performance of the OncoSec Medical System and applicator.
The conclusions for the these endpoints were also positive, the company added, 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," he concluded.
Surgery is often the first treatment approach for head and neck cancers, despite the damage to surrounding healthy tissue and problems with loss of function. Treatment can also involve radiation therapy, where the tumour 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 percent, depending on the size and location of the tumour.
The phase IV pre-marketing study was done in 11 European clinical centres, and the results were presented at the 5th European Conference on Head and Neck Oncology in Poznan, Poland on Friday, April 20, 2012.
Each year, there are around 150,000 new cases of head and neck cancer in Europe, resulting in 65,000 deaths. Worldwide, roughly 560,000 cases of head and neck cancer are diagnosed, and 300,000 patients are expected to die annually.
OncoSec's ElectroChemotherapy treatment allows for the local application of a chemotherapeutic agent, bleomycin, directly into a tumour and the healthy margin of tissue surrounding the tumor, selectively killing cancerous cells.
The company is also in the midst of its clinical development plan for its locally administered and potentially systemic ElectroImmunotherapy program, which uses the OMS system to deliver a DNA-based immunotherapy, known as DNA IL-12.
The goal is to launch three phase 2 based ElectroImmunotherapy trials for rare skin cancer indications, two of which have already been started. OncoSec is also on track to release data from these studies in the second half of this year.
Last month, OncoSec closed a $7.75 million public offering, funds from which it will use for general corporate purposes, including clinical trial costs and research and development expenses.