OncoSec says enrollment 50% complete for phase II melanoma trial

OncoSec Medical (OTCBB:ONCS) said Tuesday that enrollment for its ongoing phase II metastatic melanoma trial testing the company's OMS ElectroImmunotherapy is now 50 per cent complete.

The locally administered and potentially systemic ElectroImmunotherapy program uses the OMS electroporation system to deliver a DNA-based immunotherapy, known as DNA IL-12.

The electroporation system 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 been 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 and radiation.

The company said that the phase II multi-center clinical trial named OMS-I100, is investigating the safety and efficacy of DNA IL-12 with electroporation, and has completed approximately 50 percent of enrollment.

Based on safety data so far, no grade three or higher adverse events related to the treatment have been reported, OncoSec said, "and most reported adverse events were treatable and transient."

The preliminary results were presented by principal investigator, Dr. Adil Daud, at the second European Post-Chicago Melanoma meeting in Munich, Germany.

"Interest in this study has been encouraging, and we expect to complete enrollment before the end of this year," said Daud. 

"We look forward to continuing follow-up of the patients that have been treated in order to measure any indication of a systemic immune response using DNA IL-12 and electroporation."

A total of up to 25 patients with stage III or IV cutaneous and in-transit metastatic melanoma will be enrolled in the phase II study.

The trial is designed to assess local and distant objective response in melanoma lesions following treatment, with a primary endpoint of 24 weeks.

At 12 months, patients will be moved to the follow-up phase of the study and will be followed for up to five years for safety, the company added.

"Although preliminary, these results may validate the safety and tolerability of DNA IL-12 and electroporation that was demonstrated in the Phase I study," said OncoSec president and CEO, Punit Dhillon.

"Following the design and implementation of our clinical development plan in 2011, we are pleased with the rapid enrollment for this study since initiation in February 2012, and believe it supports the adoption of the technology through our collaboration with leading academic institutions.

"We look forward to presenting an interim analysis of the clinical and immune response for this study later this year."

OMS ElectroImmunotherapy is currently being developed in phase II studies for the treatment of three rare skin cancer indications - metastatic melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma.

Between 1992 and 2004, melanoma incidence increased 45 per cent, or 3.1 percent annually. Approximately 75 per cent of skin cancer deaths are from melanoma.

OncoSec Medical is a biopharmaceutical company developing OMS ElectroOncology therapies to treat solid tumor cancers and metastatic disease.