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(Sharecast News) - Crism Therapeutics said on Monday that it has received both regulatory clearance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) and ethical approval from a UK Research Ethics Committee to begin its registration-grade phase two trial of irinotecan-ChemoSeed in glioblastoma patients.
The AIM-traded firm said the open-label study, due to start in the first quarter of 2026 at leading UK neuro-oncology centres, would evaluate the safety, tolerability, and efficacy of Crism's biodegradable implant technology, which delivers sustained-release irinotecan directly into the tumour resection margin after surgery.
Designed in line with regulatory expectations for future marketing authorisation, the trial would also allow interim analyses to support potential expedited approval.
"We are delighted to have received both regulatory and ethical approval to begin our phase two study," said the company's chief scientific officer, professor Chris McConville.
"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."
Professor Garth Cruickshank, emeritus professor of neurosurgery at the University of Birmingham and a scientific advisor to Crism, added that 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.
"This approach safely enables high antitumour concentrations without evidence of associated neurotoxicity.
"Patients and surgeons will surely welcome such a pragmatic and truly practical step forward in treatment for glioblastoma."
Crism said it was working with its clinical research organisation Aixial Group to activate the first site and enrol patients from early next year.
At 1439 BST, shares in Crism Therapeutics Corporation were down 4.29% at 10.05p.
Reporting by Josh White for Sharecast.com.
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