THE ROADHOUSE PHARMACY: OncoSil Medical Limited (ASX: OSL) has been granted Ethics Approval for the Australian hospital sites for the Pivotal Clinical Trial for the company’s lead product candidate, the OncoSil™ localised radiation therapy treatment for pancreatic cancer.
The company said the Ethics Approval for the Australian sites in the OncoSil™ Pivotal Clinical Trial was an advancement in the product’s trial process, and is the culmination of a detailed ethics submission process withits Hospital Ethics Committee, over the past four months.
With Ethics Approval in place for the Australian component of the trial, OncoSil Medical indicated it will now work to finalise arrangements for the first group of hospitals to commence recruiting patients into the OncoSil™ Pivotal Clinical Trial.
The company anticipates the first trial hospitals will be in Australia.
The company indicated it is continuing to make preparations for an Investigational Device Exemption (IDE) submission for OncoSil™ to the US Food and Drug Administration (FDA), and expects to submit an IDE in the near future.
OncoSil Medical considers an IDE submission to represent a major step in the regulatory pathway for OncoSil™, and would be the first step towards securing the FDA’s commercial approval for OncoSil™ under a Premarket Approval (PMA).
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.
OncoSil Medical said radiation therapy, such as that supplied by OncoSil™, is known to kill tumour cells.
“We are delighted with the continued progress achieved in OncoSil™’s clinical development program,” OncoSil Medical CEO Dr. Neil Frazer said in the company’s announcement to the Australian Securities Exchange.
“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.”