OncoSil Medical (ASX:OSL) will likely trade higher on news that it has been granted Ethics Approval for the Australian hospital sites proposed for the pivotal clinical trial of its OncoSil™ localised radiation therapy treatment for pancreatic cancer.
It will now seek to finalise arrangements for trial hospitals in Australia to commence patient recruitment.
The Ethics Approval for the Australian sites in the OncoSil Pivotal Clinical Trial is a significant advancement in the product's trial process, and is the culmination of a detailed ethics submission process with its Hospital Ethics Committee, over the past 4 months.
Oncosil also continues to make preparations for an Investigational Device Exemption (NYSE:IDE) submission to the US Food and Drug Administration and expects to submit this in the near future.
An IDE submission would represent another significant milestone in the regulatory pathway for OncoSil, and is the first step towards securing the FDA commercial approval under a Premarket Approval.
Leading Cancer Technology
OncoSil is an implantable device that emits radiation directly into a pancreatic tumour, and the surrounding pain conducting nerves, and delivers radiation therapy locally for up to three months.
The device is inserted directly into the centre of the tumour using well established technology in a short 15-30 minute procedure.
This has been proven to kill tumour cells, and provides the major benefit of reducing systemic bodily exposure to radiation.
So Oncosil targets the cancerous cells more effectively, whilst minimising physical and psychological trauma to the patient.
Pathway to Commercialisation
OncoSil commenced its Pivotal Clinical Trial in March and the Company will provide further updates on the progress of the trial in due course.
Notably, OncoSil is classified by regulators as a class III medical device, not a drug.
In drug development, human studies are typically undertaken as phase I, phase II and phase III studies, however medical device development studies are undertaken as pilot and pivotal/registration studies.
Thus medical devices typically require less clinical trial work for approval, less funding and have a faster time to approval when compared to drug development.
The Pivotal Clinical Trial, which also has the potential to be a Global Registration Study, is a landmark event in Oncosil's development pathway to commercialise its flagship product as a viable treatment option for pancreatic cancer patients in global markets.
The Pivotal Trial will enrol 150 patients across 20 trial sites and will compare patients receiving standard chemotherapy treatment with patients receiving chemotherapy plus OncoSil™ treatment, in a randomized and controlled fashion.
If positive, data generated by the trial may facilitate the commercialisation of OncoSil™, including in the US, which is the world's largest health care market.
OncoSil Medical CEO Dr. Neil Frazer added:
"We are delighted with the continued progress achieved in OncoSil™'s clinical development program.
"The grant of Ethics Approval for the Australian arm of the trial is another step in the product's development pathway, and the OncoSil team continues its work to advance the trial process.
"Over the coming months, we look forward to bringing the first group of trial hospitals on-line and commencing the patient recruitment process."
Pancreatic Cancer and the OncoSil Opportunity
Pancreatic cancer has a high mortality rate, and treatment remains a challenge.
OncoSil Medical believes that new implantable radiotherapies such as OncoSil™ may have the opportunity to treat the disease and the debilitating pain associated with it.
In the US, over 40,000 patients are diagnosed with pancreatic cancer each year.
Granting of this Ethics Approval for its Pivotal Clinical Trial is a significant milestone for OncoSil which brings closer the monetisation event of commercialisation.
With OncoSil, and its injectable "liquid radiation" product in OncoCal, OSL has two treatments at different stages of development, both moving towards commercialisation and cashflow.
Both OncoSil and OncoCal may be used in conjunction with existing cancer treatments; they are not mutually exclusive. Indeed, they have the potential to synergistically complement traditional cancer therapy.
Upcoming newsflow and price catalysts for OSL include bringing the first group of trial hospitals on-line.
Additional catalysts include the submission of an Investigational Device Exemption in the US for OncoSil, and proof of concept in animal models for OncoCal, both later this year.
Then in the first half of 2015, investors can look forward to full patient accrual for the ONC-301 Pivotal Study as well as CE Mark registration.
On preliminary analysis, Proactive Investors anticipates a valuation for OSL of between $0.20-$0.30, within six to nine months.
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