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.
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
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
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
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.
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.
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.
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
"We look forward to presenting an interim analysis of the clinical and immune response for this study later this year."
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.
1992 and 2004, melanoma incidence increased 45 per cent, or 3.1 percent
annually. Approximately 75 per cent of skin cancer deaths are from
OncoSec Medical is a biopharmaceutical company
developing OMS ElectroOncology therapies to treat solid tumor cancers
and metastatic disease.