How Did OncoSil Manage Delayed PANCOSIL Trial Data Disclosure?
OncoSil Medical Limited has addressed ASX concerns over delayed disclosure of PANCOSIL clinical trial results, confirming compliance with continuous disclosure obligations despite procedural oversights.
- Investigator-initiated PANCOSIL trial data owned by Amsterdam UMC
- Contractual obligation for 30-day prior data disclosure not met by investigators
- OncoSil unaware of trial data before public presentation at CIRSE Congress
- Trading halt implemented promptly after data release to ensure market fairness
- Company confirms compliance with ASX Listing Rules 3.1 and 15.7
Background on the PANCOSIL Trial and Data Ownership
OncoSil Medical Limited (ASX, OSL), a biotechnology company focused on innovative cancer treatments, recently responded to an ASX compliance query regarding its disclosure of clinical trial results from the PANCOSIL study. This trial, conducted by the Amsterdam University Medical Centre (Amsterdam UMC), was an investigator-initiated study (IIT) evaluating OncoSil's brachytherapy treatment for pancreatic cancer. Crucially, the data generated belongs to Amsterdam UMC, which independently managed the trial and its disclosures.
Contractual Framework and Disclosure Challenges
OncoSil had a written agreement with Amsterdam UMC that included provisions to support OncoSil’s ASX disclosure obligations. This contract required the principal investigator to provide draft publication materials 30 days before any public presentation. However, Amsterdam UMC did not comply with this clause for the PANCOSIL trial results presented at the CIRSE Annual Congress in mid-September 2025. As a result, OncoSil was not privy to the data content prior to the public release, limiting its ability to pre-announce the findings.
Response to ASX and Market Actions
Upon the public presentation of the data by Dr. Vos from Amsterdam UMC on 16 September 2025 (Sydney time early 17 September), OncoSil promptly entered a trading halt before market open. This pause allowed the company’s management and board to analyze the results thoroughly and prepare an informed announcement. The formal ASX release followed on 18 September 2025 after board approval, ensuring compliance with Listing Rules 3.1 and 15.7. OncoSil has since implemented additional training for its executive team to prevent similar oversights.
Implications for Continuous Disclosure Practices
This episode highlights the complexities companies face when clinical trial data is controlled by third-party investigators. While OncoSil structured its agreements to safeguard disclosure obligations, the failure of Amsterdam UMC to provide timely data underscores the risks inherent in investigator-initiated studies. The ASX’s scrutiny and OncoSil’s transparent response reinforce the importance of robust internal controls and clear contractual terms to manage market-sensitive information.
Looking Ahead
OncoSil’s confirmation of compliance with ASX rules closes this chapter but raises questions about future collaborations and disclosure protocols. Investors will be watching how the company balances scientific partnerships with regulatory demands, especially as it advances its oncology pipeline.
Bottom Line?
OncoSil’s handling of the PANCOSIL data delay underscores the delicate balance between clinical research independence and market disclosure obligations.
Questions in the middle?
- Will OncoSil renegotiate data access terms with Amsterdam UMC to prevent future disclosure delays?
- How might the delayed announcement affect investor confidence and share price volatility?
- Could ASX impose stricter oversight or penalties for similar disclosure lapses in investigator-initiated trials?
