RE: Newbie here18 Feb 2026 10:59
Should get some news in the next few weeks. Here's a reminder of the trial, taken from the RNS. The open label is most interesting. First patient dosing will undoubtedly bring attention to the share. Fully expect it to rise accordingly.
The approved study, titled "An Open-label Phase 2 Safety and Efficacy Trial of Irinotecan ChemoSeed Administered Directly into the Resection Margin in Patients with Surgically Resectable Glioblastoma", is designed to assess the safety, tolerability, and efficacy of irinotecan-ChemoSeed, CRISM's proprietary, biodegradable implant technology delivering sustained-release irinotecan directly into the tumour resection margin following surgical removal of the glioblastoma tumour. The trial has been designed in alignment with regulatory expectations for future marketing authorisation submissions.
Key Highlights:
· Regulatory (MHRA) and Ethical (REC) approval received
· Trial confirmed to initiate in Q1 2026 at leading UK neuro-oncology centres
· Open-label format supports interim analysis, reporting of early results and potential for expedited regulatory approval
· ChemoSeed platform targets local recurrence with sustained, localised chemotherapy
· Registration-grade Phase 2 design supports pathway to marketing authorisation and commercialisation.
Professor Chris McConville, Chief Scientific Officer of CRISM Therapeutics, commented:"We are delighted to have received both regulatory and ethical approval to begin our Phase 2 study. This is a critical inflection point for CRISM as we prepare to clinically validate our ChemoSeed platform in patients with glioblastoma, an area of immense unmet need. With these approvals secured, we are now in a position to move rapidly into trial activation and first patient dosing. We believe the data from this study could serve as a foundation for future regulatory submissions and commercial advancement."
Professor Garth Cruickshank, Emeritus Professor of Neurosurgery at the University of Birmingham, and scientific advisor to CRISM, added: "This is a very exciting development in the drive to treat one of the most complex cancers. The technical innovation of putting the tumour killing drug irinotecan into the tumour site at the time of the surgery offers the very best chance to hit the tumour when it is at its smallest. The release process at least covers the time until radiotherapy and or temozolomide are introduced providing a much more powerful sustained antitumour assault. The local deposition of drug already known to attack glioblastoma, avoids systemic side effects, so no additional problems for patients. This approach safely enables high antitumour concentrations without evidence of associated neurotoxicity. Furthermore, the spectrum of patients likely to respond is greater than for any gene targeted or existing immunotherapy. Patients and surgeons will surely welcome such a pragmatic and truly practical step forward in treatment for glioblastoma."