OncoSil Medical (ASX:OSL) has now filed an Investigational Device Exemption (IDE) with the US Food and Drug Administration (FDA) for its lead product candidate, the OncoSil™ localised radiation treatment for cancer.
This is a significant milestone in the development pathway for OncoSil™ in pancreatic cancer and is the first step towards securing FDA commercial approval for OncoSil™ under a Pre-market Approval (PMA).
Daniel Kenny, CEO, OncoSil Medical, commented:
“I am delighted to report that we have filed our Investigational Device Exemption submission with the US FDA.
"This represents a key milestone in the development timeline for OncoSil™ in the USA.
"In conjunction with our ongoing CE Mark process with the European regulator, the company now has an active global regulatory licensing pathway.”
Additional submission details
OncoSil formally filed its IDE submission on 10th December 2015 after successfully completing a lengthy pre-IDE process.
The pre-IDE process involved an FDA review of the proposed Clinical Investigational plan including the endorsement of clinical endpoints and outcomes measures.
The IDE submission is the culmination of a detailed body of preparatory work conducted by OncoSil’s medical and regulatory team over a six month period, which was undertaken in parallel with its Conformité Européenne (CE) Mark application process and ongoing review with the European regulatory body.
OncoSil said that it is pleased to report significant, positive progress with its CE Mark application, and the process remains ongoing.
The formal review continues with the Notified Body and the company anticipates a decision in the New Year.
US Pancreatic cancer market opportunity
According to the most recent American Cancer Society statistics, the number of new cases of pancreatic cancer in the United States in 2015 is expected to be 48,960.
Pancreatic cancer has a poor prognosis and is responsible for a relatively high percentage of cancer-related mortality.
The number of deaths in 2015 is expected to be 40,560. Pancreatic cancer is the 4th leading cause of cancer mortality in the US, after lung cancer (158,000), colon cancer (49,700) and breast cancer (40,730).
The relative five-year survival rate for all stages of pancreatic cancer combined is approximately 5%.
There currently exists a large un-met medical need for viable, new treatment options for pancreatic cancer which OncoSil Medical aims to meet with OncoSil™.
The estimated world-wide market opportunity for OncoSil™ in pancreatic cancer exceeds $1 billion.
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