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OncoSil Medical Limited (ASX:OSL) revealed findings from an independent formulation analysis by Institut Galien Paris-Saclay, confirming that OncoSil™ microparticle concentrations can be significantly increased without affecting injectability. These results bolster the company's development efforts to expand the dosing window per batch, enhance manufacturing efficiency, and reduce production costs for its localized pancreatic cancer treatment device.
Key Points
- OncoSil Medical Limited (ASX:OSL) is a global interventional oncology medical device company focused on treating unresectable locally advanced pancreatic cancer using the OncoSil™ device.
- An independent study by Institut Galien Paris-Saclay demonstrated that OncoSil™ microparticles can be suspended at substantially higher concentrations than current commercial formulations without increasing injection flow resistance.
- Viscosity testing across eight concentrations from 0 mg/mL to 150 mg/mL showed consistent shear-thinning behavior with no viscosity rise at the high shear rates experienced during injection.
- Higher-concentration formulations may extend the usable dosing window per batch, reduce manufacturing frequency, improve production efficiency, and lower costs pending validation through ongoing development and regulatory approval.
OncoSil Medical’s Commitment to Treating Unresectable Pancreatic Cancer
OncoSil Medical Limited is a global medical device company specializing in interventional oncology, aiming to improve cancer patient outcomes through targeted intratumoural delivery of Phosphorous-32 (P) microparticles combined with chemotherapy. The company’s OncoSil™ device targets unresectable locally advanced pancreatic cancer (LAPC), a challenging cancer type. This approach enables clinicians to deliver higher radiation doses directly to tumors compared to external beam radiotherapy, while minimizing radiation exposure to surrounding vital organs.
Pancreatic cancer remains a major global health challenge. According to OncoSil Medical, it ranks as the 12th most common cancer in men and 11th in women worldwide, with about 500,000 new cases annually. The disease typically has a poor long-term survival outlook due to late-stage diagnosis. OncoSil™ holds CE Mark approval, authorizing marketing in the European Union and United Kingdom, and is designated as a breakthrough device in Europe and the United States, highlighting its clinical importance for patients with limited treatment options.
Global Regulatory Approvals and Market Presence of OncoSil™
OncoSil Medical has obtained regulatory approvals and established commercial operations in over 30 countries, including the European Union, United Kingdom, Australia, Türkiye, and Israel. This extensive regulatory footprint underscores the company’s progress in positioning OncoSil™ as a viable treatment across diverse healthcare systems.
Commercial treatments using OncoSil™ have been performed in Spain, Italy, Austria, Germany, Greece, Türkiye, Portugal, Israel, and the United Kingdom. This broad clinical use demonstrates the device’s acceptance beyond regulatory clearance, confirming its integration into real-world practice and laying the groundwork for further market expansion and revenue growth.
Independent Study on Viscosity and Microparticle Concentrations
OncoSil Medical announced results from an independent study by the Physical Pharmacy Team at Institut Galien Paris-Saclay, part of Université Paris-Saclay. The study evaluated the flow properties, specifically viscosity, of OncoSil™ suspensions across multiple microparticle concentrations. Using non-radioactive "cold" microparticles identical in composition and size to the clinical product ensured laboratory results are directly relevant to commercial formulations.
Viscosity was measured at eight concentrations ranging from 0 mg/mL (diluent only) to 150 mg/mL. All suspensions exhibited expected shear-thinning behavior. Contrary to typical expectations for particle suspensions, viscosity did not increase with higher particle concentrations. At the high shear rates encountered during injection—critical for clinical use—viscosity remained consistent across all concentrations. Particle volume fractions stayed low, approximately 6% even at the highest loading, indicating stable suspension characteristics throughout the tested range.
Impact of Phosphorous-32 Half-Life on Formulation Needs
A key factor driving formulation development is the radioactive decay of Phosphorous-32 (P), the active therapeutic agent in OncoSil™. With a half-life of 14.27 days, the radioactive dose decreases exponentially post-manufacture. This decay necessitates higher microparticle counts in treatments performed later in the product’s shelf life to maintain therapeutic activity, limiting the usable window per batch and complicating manufacturing and clinical scheduling.
Formulating reliably at higher particle concentrations addresses this limitation by allowing longer usage windows and greater scheduling flexibility. This operational advantage benefits manufacturing, logistics, and patient care, targeting a core constraint in the company’s business model.
Study Supports Advancement of Higher-Concentration Formulations
OncoSil Medical stated that the independent study validates its formulation development strategy, providing a robust technical foundation for further research. Rheology data—assessing suspension flow under stress—support exploring higher-concentration formulations. Crucially, findings suggest increased microparticle concentration does not impair injectability, a vital clinical requirement for safe and effective use.
Managing Director and CEO Nigel Lange described the results as "an important step in our formulation development program," emphasizing that the rheology data justify continued investigation and upcoming detailed injectability testing. The company expressed optimism about building on these findings as development progresses.
Manufacturing and Cost Advantages of Higher-Concentration Formulations
If confirmed through further studies and regulatory review, higher-concentration OncoSil™ formulations could extend dosing windows per batch, reduce unit volumes handled at treatment sites, and lower manufacturing frequency. These improvements would enhance production efficiency and reduce costs, benefiting both the company and healthcare providers administering the treatment.
OncoSil Medical highlighted that these benefits depend on "further validation through planned studies," reflecting the rigorous regulatory and quality standards for medical devices containing radioactive materials. The company’s cautious approach ensures safety and efficacy remain paramount.
Next Steps in Formulation Development
While viscosity results are promising, OncoSil Medical plans additional validation focusing on injectability in clinical-like scenarios. This phase is essential to confirm that laboratory flow characteristics translate into safe, reliable clinical performance during intratumoural injections by healthcare professionals.
This progression from rheology to injectability testing aligns with a scientifically sound development pathway, ensuring formulation changes do not compromise the device’s established safety and efficacy profile as approved under CE Marking and other regulatory clearances.
Regulatory and Market Implications of Formulation Optimization
The formulation development program and independent study findings have strategic implications for OncoSil Medical’s competitive positioning and regulatory compliance. Enhanced manufacturing efficiency and cost reductions could improve commercial competitiveness, especially as the company expands into new markets and seeks broader adoption.
Regulatory processes will require careful management to ensure formulation changes meet all safety and efficacy standards. Modifications to radioactive medical device formulations typically necessitate regulatory notifications and additional data submissions. OncoSil Medical’s emphasis on "further validation through planned studies" underscores its commitment to regulatory rigor and patient safety.
Competitive Landscape in Interventional Oncology and Pancreatic Cancer
Operating within the growing interventional oncology sector, OncoSil Medical’s OncoSil™ device offers a targeted alternative for treating unresectable locally advanced pancreatic cancer, where treatment options are limited. Standard care involves systemic chemotherapy and external beam radiation, while OncoSil™ delivers intratumoural radiation that spares adjacent organs, addressing a critical unmet clinical need.
The breakthrough device designation in Europe and the US highlights regulatory recognition of OncoSil™ as a significant advancement. The formulation development program enhances the device’s practical utility and manufacturability, supporting OncoSil Medical’s long-term growth and competitive advantage as adoption increases.
Significance of Formulation Science in Medical Device Development
The independent study underscores formulation science’s vital role in optimizing medical devices, especially those involving particle suspensions and radioactive materials. Effective formulation requires understanding ingredient behavior under clinical stresses and changes over time due to physical and radioactive decay.
By investing in independent research at Institut Galien Paris-Saclay, OncoSil Medical strengthens the scientific foundation of its development program and gains objective validation of its formulation strategies. This enhances credibility with regulators, clinicians, and customers, ensuring formulation changes are supported by rigorous science rather than marketing claims.
