British Standards Institute (BSI) grants European CE marking for the OncoSil™ System and grants OncoSil™ breakthrough therapy designation for the treatment of locally advanced pancreatic cancer

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British Standards Institute (BSI) grants European CE marking for the OncoSil™ System and grants OncoSil™ breakthrough therapy designation for the treatment of locally advanced pancreatic cancer

The CE Marking certification is a validation of the OncoSil™ device and its clinical performance. Clinical studies by Oncosil have demonstrated a median overall survival of 16.1 months in patients treated with OncoSil™ plus chemotherapy (CT) almost double the accepted median overall survival in patients withunresectable pancreatic cancer1.

OncoSil CEO and Managing Director Daniel Kenny said:
“Designation of the OncoSil™ device as a breakthrough device is a validation of our platform technology which can be used to treat multiple solid tumour types such as liver, biliary duct and of course pancreatic cancer.”

“Having secured CE Marking approval, our focus is now on multiple registration filings in jurisdictions which recognise CE Marking certification. This activity is unaffected by the COVID19 pandemic,” added Mr Kenny.

“The COVID-19 pandemic will impact our launch preparedness and delay our European launch as the Company expects disruptions due to limited hospital access in the coming months for new site initiation and training as well as shipping and logistical disruption. We would like to thank our shareholders for their support through this long but ultimately rewarding
journey.”

OncoSil™ – a Breakthrough Device & platform technology

In addition to CE Marking approval the OncoSil™ device has now been officially classified as a
“breakthrough device” as defined under EU Medical Device guidance. In the EU a “breakthrough device” is defined as one that delivers clinical benefit to patients for unmet medical needs which are life threatening, and for which current medical alternatives are insufficient or carry significant risks.

The OncoSil™ device is now officially designated as a breakthrough device in both the EU, and the UK as well as the US as per ASX announcement 18 March 2020. OncoSil™ is a first in class medical device comprising microparticles containing phosphorus-32 (P-32), a pure beta-emitter radioisotope, implanted directly into a patient’s pancreatic tumour via endoscopic
ultrasound guidance.

Compelling clinical data from PanCO underpinned CE Marking approval. The CE Marking approval was achieved based on the compelling clinical outcomes from the PanCO study.
Supporting the approval was a detailed comparative analysis (naïve in-direct treatment comparison) of the PanCO results with “state-of-the-art” treatment for unresectable locally advanced pancreatic cancer.

The “state-of-the-art” treatments included a broad range of clinical studies of systemic chemotherapy (CT-only) and induction chemotherapy plus consolidated chemo-radiotherapy (ICT+CCRT) regimens supported in clinical guidelines for the treatment for unresectable LAPC.

This comparative analysis confirms that the OncoSil device, when combined with contemporary systemic chemotherapy regimens, demonstrates the following:

Excellent Local Disease Control (LDCR)
• Local Disease Control Rates at 16 weeks (LDCR16 weeks) of 90.5% in the Per Protocol (PP)
population (p=0.0001) that received OncoSil™ plus CT, demonstrate that the PanCO study met
its a priori primary performance endpoint and convincingly demonstrates that OncoSil™ plus CT is better than CT alone.

Prolonged Overall Survival (OS)
• Prolonged median overall survival of 16.1 months in the PP population. (as of May 2019).
• Almost double the accepted median OS for patients with unresectable pancreatic cancer1
• In the naïve indirect treatment comparison, the PanCO median OS results were significantly
longer (p<0.001) than CT-only and ICT + CCRT regimens, representing a clinically relevant 20%
reduction in the risk of death compared to CT-only and ICT + CCRT studies.

Encouraging rate of Surgical Resection with Curative intent
• An encouraging rate of surgical resection with curative intent in nearly one-in-four PanCO
patients (23.8%) were downstaged. This rate is significantly greater than those reported in the
CT-only and ICT + CCRT studies (p<0.001) and, notably, the rate of R0 margin status was 80%.
• In the systemic literature review analyses the CT-only resection rate was 7.7%, and the CT-only and ICT + CCRT resection rate was 9.9% compared with the PanCO resection rate of 23.4%
• Surgical resection of pancreatic cancer, particularly in patients previously determined to be
unresectable, profoundly improves patients’ prognosis from a five-year survival rate of 5% to
greater than 20%.

Prolonged Progression Free Survival (PFS)
• Progression-free survival (PFS) was also prolonged (9.3 months in the ITT and PP populations), and was significantly greater than ‘state-of-the-art’ CT – only and ICT + CCRT studies (p<0.001).

Higher Disease Control Rate
• Disease control and overall response rates in the PanCO study – 100% and 31.0% respectively
in the PP population – underline the response following OncoSil™ administration and were again significantly greater than the CT – only and ICT + CCRT studies in the naïve indirect treatment comparison.

Marked Tumour Volume Reduction
• OncoSil™ treatment results in marked tumour volume reduction. Overall, treatment with
OncoSil™ resulted in a median maximal volumetric reduction of 52% from baseline.
• Median tumour volumetric reduction at 16 weeks was 38% (p<0.0001)
• In the PanCO study a number of patients demonstrated substantial tumour volume reductions up to 74% volumetric reduction at Week 8 and up to 90% volumetric reduction at Week 16Significant CA19-9 tumour marker reduction
• There was a significant reduction in CA19-9 tumour marker with a median CA19-9 reduction of -77.8%; (p<0.0001)

Superior outcomes to comparators
• The naive indirect treatment comparison confirms that the PanCO study results were consistently and statistically significantly better than the results from CT-only and ICT+CCRT studies, and clearly demonstrates that OncoSil™ plus CT provides clinically relevant benefits for patients with unresectable LAPC that are superior to those reported with CT alone

Safety
• Excellent safety profile overall, with no evidence of significant safety concerns or
unexpected/serious toxicities associated with the OncoSil™ device and/or implantation
procedure over a prolonged study timeframe.
• The OncoSil™ device provides a valuable treatment option in an area of high unmet medical need with an acceptable safety and tolerability profile.
• The clinically relevant benefits of OncoSil™ combined with systemic chemotherapy in appropriate patients with unresectable LAPC more than outweigh the identified risks and represent a favourable risk-benefit profile.

Reference: 1 Loehrer PJ et al. J Clin Oncol 2011Nov 1;29 (31) 4105-12