irinotecan-ChemoSeed / CRISM Therapeutics - LARVOL DELTA

OPTICAL: Irinotecan-ChemoSeed in Surgically Resectable Glioblastoma (clinicaltrials.gov) - P2 | N=147 | Recruiting | Sponsor: CRISM Therapeutics LTD | Not yet recruiting ➔ Recruiting | Initiation date: Mar 2026 ➔ Aug 2026

Enrollment open • Trial initiation date • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

Awarding of Orphan Drug Designation by the FDA (polaris.brighterir.com) - "CRISM Therapeutics Corporation...is pleased to announce that the U.S. Food and Drug Administration ('FDA') has granted Orphan Drug Designation ('ODD') to irinotecan for the treatment of malignant glioma, which is broader than the original designation request for glioblastoma (a Grade IV glioma) and includes all high grade (Grade III and IV) gliomas...This U.S. regulatory milestone follows the previously granted Innovation Passport for the ChemoSeed™ platform by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under the Innovative Licensing and Access Pathway (ILAP)."

Orphan drug • Glioblastoma • Glioma