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OncoSil Medica Limited (ASX:OSL)

OncoSil (ASX:OSL) Completion of Recruitment in PANCOSIL Study

OncoSil Medical Limited (ASX:OSL)

Highlights: 

  • Patient recruitment for the PANCOSIL trial has now been successfully completed. 
  • This trial is an important part of OncoSil Medical’s well-articulated clinical development strategy. 
  • The primary objective of the PANCOSIL trial is to assess a novel delivery method for the OncoSil™ device via a CT-guided percutaneous approach.
  • OncoSil Medical expects preliminary data from the PANCOSIL study to be available in late 2025.

Pancreatic cancer treatment device company OncoSil Medical Limited (ASX:OSL) (“OncoSil” or “the Company”) is pleased to announce the successful completion of patient recruitment for the PANCOSIL Investigator Initiated Study. Achieving this milestone is yet another important step in the Company’s well-articulated clinical development strategy.

OncoSil™ device’s clinical development accelerated by PANCOSIL study

 The PANCOSIL study is an open-label, single-arm Phase 1–2 feasibility trial initiated by Amsterdam University Medical Center (Amsterdam UMC) in the Netherlands. The study is evaluating the safety and feasibility of CT-guided percutaneous radionuclide therapy using the OncoSil™ device in patients with non-progressive locally advanced pancreatic cancer (LAPC). OncoSil Medical announced ethics committee approval for the PANCOSIL study on 5 June 2023 and first patient treatment on 29 November 2023.

A total of 20 patients have now been enrolled in the study. Its primary objective is to assess a novel delivery method for the OncoSil™ device via a CT-guided percutaneous approach. This approach has the potential to simplify administration and lower barriers to adoption, supporting wider market penetration and real-world clinical use.

This innovative method represents a potentially transformative step in how OncoSil™ therapy can be delivered—providing a less invasive and more accessible option for treatment centres worldwide. OncoSil Medical anticipates preliminary data from the PANCOSIL study to be available in late calendar 2025.

Professor Marc Besselink, Lead Investigator at Amsterdam UMC, said:

“By achieving full recruitment, the PANCOSIL study opens a new chapter in the evolution of localised treatment of pancreatic cancer. By developing CT-guided percutaneous administration under local anaesthesia, we will make OncoSil therapy more broadly applicable. The study has the potential to redefine the delivery model and bring meaningful benefits to both clinicians and patients.”

Nigel Lange, CEO & Managing Director of OncoSil Medical, said: 

“The completion of recruitment in the PANCOSIL study represents a critical milestone in the clinical development of the OncoSil™ device. On behalf of OncoSil Medical, I want to thank Professor Besselink and the entire Amsterdam UMC team for their leadership and vision over the design and implementation stages of the PANCOSIL study. The study’s importance to our device’s development process cannot be overestimated, with it representing a major opportunity to unlock new pathways for delivering our therapy and accelerating its adoption in clinical practice. We now look forward to the results from the PANCOSIL study and expect that they will make an invaluable contribution to our efforts to make the OncoSil™ device a go-to treatment for patients with unresectable locally advanced pancreatic cancer – one that has acknowledged flexibility and is widely accessible.”  

To read the announcement, please click here

 


About us:

About OncoSil Medical
OncoSil Medical Limited (ASX:OSL) has developed a cancer treatment device, the OncoSil™ brachytherapy device, which is a critical component of a revolutionary brachytherapy treatment for locally advanced unresectable pancreatic cancer. This type of cancer is the 12th most common cancer in men and the 11th most common cancer in women across the globe, with some 500,000 new cases of pancreatic cancer detected every year. With pancreatic cancer typically diagnosed at a later stage, it has a poor prognosis for longterm survival.

The OncoSil™ device delivers a targeted intratumoural placement of Phosphorous-32 (32P) in the treatment of locally advanced unresectable pancreatic cancer. This occurs via injection directly into a patient’s pancreatic tumours under endoscopic ultrasound guidance and takes place in combination with gemcitabine-based chemotherapy. 

The OncoSil™ device that has already received breakthrough device designation in the European Union, United Kingdom and United States for the treatment of locally advanced unresectable pancreatic cancer in combination with chemotherapy. CE Marking has additionally been granted for the OncoSil™ device, which can be marketed in the European Union, United Kingdom.

While clinical trials involving the OncoSil™ device continue to occur, the Company is simultaneously moving to commercialise this unique medical technology. It is currently approved for sale in 30+ countries including European Union, United Kingdom, Türkiye and Israel, with initial commercial pancreatic cancer treatments using the device already undertaken in Spain, Italy and Israel.

To learn more, please visit: www.oncosil.com


Contact details:

For further information, please contact:

Mr. Nigel Lange
CEO & Managing Director
E: [email protected]
T: +49 30 300 149 3043

Mr. Nathan Jong 
Company Secretary
E: [email protected]
T: +61 3 9864 4810

Investor relations
Ms. Julia Maguire
The Capital Network
Media and Investor Enquiries
E: [email protected]
T: +61 2 7257 7338