OncoSil Medical (ASX:OSL) and Monash Health has recruited the first subject for a global clinical study program of OncoSil™ device in pancreatic cancer.
OncoSil™ device is a targeted radioactive isotope implanted directly into a patient’s pancreatic tumours via an endoscopic ultrasound.
Treatment with OncoSil™ is intended to deliver more concentrated and localised beta radiation compared to external beam radiation.
The recruitment of the first subject represents a significant milestone in the clinical study process to date.
The first subject has completed all baseline assessments and will now commence one month of chemotherapy prior to implantation with the OncoSil™ device.
This patient is the first in a total of 20 subjects required to meet the supplemental data request from BSI, the company’s notified body to secure CE Marking for the OncoSil™ device.
Monash Health is the largest public health service in Melbourne, and has agreed to be the lead Australian study centre.
To date, OncoSil Medical has confirmed the participation of 16 centres for the global pancreatic clinical study program.
One of these centres, St Vincent’s Hospital, Sydney received Ethics approval on 16 March and is expected to commence recruiting subjects for the study program in the coming weeks.
OncoSil Medical is working with large recruitment centres, and many of the sites included in the study are top-tier cancer centres, including MD Anderson and John Hopkins in the U.S.