In October, OncoSec received authorization to CE mark its OMS electroporation device, for use in the European Economic Area. According to OncoSec President and CEO Punit Dhillon,
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The approval marks an essential regulatory milestone on the road to commercialization and further approval of the OncoSec Medical System. The CE mark shows that OncoSec has the capability to manufacture and develop a device that meets commercial regulatory requirements.
NeoPulse utilizes the OMS system to destroy cancer cells using less harmful doses of bleomycin. Bleomycin has for the most part been given intravenously. This is not only an inefficient method of targeting cancer cells, but requires high doses to be used, which can cause significant side effects. However, in using NeoPulse to open the cell membranes and directly target cancerous cells, it has been found that effective results can be achieved with 1/20th of a traditional chemotherapy dose and it enhances the drug's ability to penetrate tumor cells by a factor of as much as 4,000.
NeoPulse is in phase IV trials, targeting early stage skin cancer tumors, with a goal to assess the ability to control growth or recurrence of the cancer six months following treatment with respect to primary tumors and locally recurrent tumors. Data from the trial showed a complete response of greater than 90% in basal cell carcinoma patients and 70% in squamous cell carcinoma patients at six months. According to Mr. Dhillon, the data shows that NeoPulse can target cancer cells and not destroy healthy tissue and may be used as an alternative to surgery,
The results of OncoSec's skin cancer program have so far shown a positive outcome among the class of patients who would typically be subjected to disfiguring surgery. We believe that NeoPulse offers a potentially significant new treatment for a variety of skin cancers.
OncoSec is also developing, ImmunoPulse, a DNA-based immunotherapy using the OMS electroporation therapy to treat solid tumors that have metastasized or spread. Chemotherapy and surgery have generally been the treatment for late stage skin cancers, but OncoSec believes utilizing ImmunoPulse therapy as a noninvasive approach could improve the quality of life for skin cancer sufferers. OncoSec has received almost $12 million in funding and is conducting simultaneous Phase II clinical trials for ImmunoPulse for three types of cancers, metastatic melanoma, Merkel cell carcinoma, and cutaneous T-Cell lymphoma. Though less common than other skin cancers, these cancers are more drug-resistant and aggressive.