Crism Therapeutics Corporation (AIM:CRTX) said the Site Initiation Visit at its lead NHS clinical trial site has been completed successfully.
The AIM-listed, UK-based drug delivery company is developing localised and sustained-release chemotherapy treatments.
The company is now working with the clinical site, the NHS Trust and its clinical partners to begin enrolling patients in the coming weeks.
The Phase II trial will test irinotecan ChemoSeed, Crism's proprietary implant designed to deliver irinotecan directly into the tumour margin following surgical removal of a glioblastoma tumour.
Site initiation is the procedural gateway that confirms a trial site is ready to screen and enrol patients under regulatory and ethical approval.
Patient recruitment is expected to start in the coming weeks.
News Intelligence what this means for the company
Crism Therapeutics has completed the procedural gateway—site initiation—for its Phase II glioblastoma trial, unblocking patient recruitment to begin within weeks. This is a concrete operational milestone that moves irinotecan ChemoSeed from regulatory approval to active enrollment, reducing execution risk on the company's lead program.
Site initiation removes a near-term binary risk and validates that the NHS trial site is ready to execute. The company now faces the clinical risk of enrollment pace and efficacy data; this milestone does not de-risk those, but it does confirm the trial infrastructure is in place and funded (via the £896,088 Innovate UK grant awarded earlier).
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