Supply Chain Validation and Hot Calibration Run of OncosilTM...

Supply Chain Validation and Hot Calibration Run of OncosilTM

Sydney, Australia, 18 August 2016: OncoSil Medical Limited (ASX: OSL) (OncoSil Medical or the Company),
a late stage medical device company focused on localised treatments for patients with pancreatic and liver
cancer, is pleased to announce that it has successfully completed a supply chain validation process including
the first hot (radioactive) calibration delivery of OncosilTM.
In preparation for the commencement of the Company’s planned global clinical study of OncoSilTM for the
treatment of pancreatic cancer (OncoPac-1) and the commercialisation of OncoSilTM
subject to attainment of
CE Mark, the Company restarted de-novo manufacturing of OncoSilTM microparticles in January 2016. The
manufacturing, supply chain validation and delivery to clinical and commercial centres of the OncoSilTM
product
is a key step to commercial sales and the treatment of patients in the OncoPac-1 Study.
In order to validate the manufacturing and distribution processes, the Company performed a full hot
calibration run of OncoSilTM microparticles on Wednesday, 17 August 2016 in the Department of Nuclear
Medicine, Royal North Shore (RNS) Hospital, Sydney which included initial training and calibration of their
equipment to ensure dose accuracy of OncoSilTM microparticles in diluent suitable for a patient treatment.
The hot calibration run encompassed the full manufacturing of OncoSilTM microparticles including
microparticle irradiation, packaging, shipping and delivery to the hospital. The successful completion of the
hot calibration run verifies the functionality of the manufacturing and distribution processes.
OncoSil Head of Manufacturing, David James commented:
“We are delighted with the safe and successful validation shipment of the dose to a typical clinical site as it
demonstrates that we are prepared for the commencement of OncoPac-1 and commercialisation. It further
shows that the staff, procedures, and commercial partners that the Company have assembled are
accomplished at manufacturing and distributing the OncoSil product.”