OncoSec Medical, a developer of OMS ElectroOncology therapies for the treatment of solid-tumour cancers, has submitted the device master file for its patented OncoSec Medical System to the US Food and Drug Administration (FDA).
The OncoSec Medical System is comprised of a generator and a handheld applicator, and is deisgned to deliver DNA-based cytokines and chemotherapeutic agents.
Clinical trials have shown the OncoSec Medical System to be both safe and effective at optimising the cellular uptake of these agents, resulting in improved therapeutic benefits for the patient.
The regulatory filing includes technical, manufacturing, clinical and non-clinical information about the OncoSec Medical System, which will facilitate an FDA review of the complete system.
OncoSec plans to initiate three Phase II clinical trials using the system: OMS-I100 for the treatment of melanoma, OMS-I120 for the treatment of Merkel cell carcinoma, and OMS-I130 for the treatment of cutaneous T-cell lymphoma.