Ethics Committee Approves PANCOSIL (Percutaneous) Clinical Trial
Melbourne, Australia – 5 June 2023: The Board of OncoSil Medical Ltd (ASX: OSL) (OncoSil or the Company), a medical device company focused on localised treatments for patients with locally advanced pancreatic cancer (LAPC), is pleased to announce that ethics committee approval has been received for the PANCOSIL clinical trial.
The Investigator Initiated Clinical Trial is led by Professor Marc Besselink of Amsterdam UMC, a leading Hepato-Pancreato-Biliary surgeon in Europe.
The study will commence recruitment this quarter and involve the treatment of 15 patients with the OncoSilTM device which will be delivered percutaneously (by inserting a needle directly through the skin into the pancreatic tumor, under CT guidance) rather than endoscopically guided by ultrasound, which is the current approved method of implantation. The outcome of this study is expected to increase the number of medical professionals who can deliver the OncoSilTM device to patients. OncoSil will provide the doses at no cost for the trial and will make a modest contribution to study personnel undertaking the clinical trial. The majority of funding contribution by OncoSil has already occurred in previous quarters.
The study is intended to develop a feasible and safe standardised approach for a percutaneous application of the OncoSilTM device, which will subsequently be confirmed in a larger group of patients, allowing for submission for approval to relevant regulators.
The Lead Investigator at Amsterdam UMC, Professor Marc Besselink said:
“I am excited to be part of an innovative Clinical Trial in developing the percutaneous application of the OncoSilTM device for patients with Locally Advanced Pancreatic Cancer, who have stable disease after several months of chemotherapy. These patients have a poor prognosis, and I am proud to be exploring an alternative delivery method for the implantation of the OncoSilTMdevice for these patents.”
OncoSil’s CEO and Managing Director, Mr Nigel Lange said:
“To have a physician of the caliber of Professor Marc Besselink undertaking this pivotal clinical study into the percutaneous application of the OncoSilTM device for patients with LAPC further validates the high regard which key opinion leaders have for the OncoSil treatment. Expanding the number of specialties capable of implanting the OncoSilTM device will assist the Company in gaining wider appeal amongst Key Opinion Leaders for the use of the OncoSilTM treatment for patients who otherwise would have limited treatment options upon diagnosis of LAPC.”