Business
GMP Manufacture of ChemoSeed
GMP Manufacture of ChemoSeed.
About this update from Crism Therapeutics Corporation
[{"type":"text","content":"\n\n \n12 August 2025\n \n\n \nCRISM Therapeutics Corporation\n(\"CRISM\", \"CRISM Therapeutics\" or the \"Company\")\n \n \nGMP Manufacture of ChemoSeed for Phase 2 Clinical Trial in Glioblastoma\n \nCRISM Therapeutics (AIM: CRTX), the innovative UK drug delivery company focused on the localised delivery of chemotherapy drugs, announces the initiation of production of a clinical batch of ChemoSeed, its proprietary sustained-release implant containing irinotecan, under Good Manufacturing Practice (GMP).\n \nThis clinical batch will be produced for the Company's upcoming open-label Phase 2 safety and efficacy trial evaluating ChemoSeed administered directly into the resection margin in patients with surgically resectable glioblastoma. US-based ProMed Pharma LLC, a Contract Development and Manufacturing Organisation (\"CDMO\"), will produce the clinical batch.\n \nThe start of production marks a critical step toward first patient dosing, expected in Q1 2026, and underscores CRISM's commitment to addressing the significant unmet need in glioblastoma, a highly aggressive brain cancer with poor prognosis and limited effective treatment options. \n \nThe Phase 2 study is designed to evaluate both safety and efficacy following direct administration of ChemoSeed into the tumour resection margin, with the goal of delivering a local high-dose of chemotherapy over a sustained period of time, while minimising systemic toxicity. This innovative approach builds on positive preclinical and early clinical data and has the potential to redefine the standard of care in post-surgical glioblastoma management.\n \nAndrew Webb, Chief Executive Officer of CRISM Therapeutics, commented: \"Initiating GMP manufacturing of ChemoSeed for our upcoming Phase 2 trial is an important step towards bringing a potentially transformative therapy to glioblastoma patients. This achievement reinforces CRISM's leading position in the localised and sustained delivery of chemotherapeutics and advances our mission to improve outcomes in some of the most challenging cancers.\"\n \nJim Arps, Director of Business Development at ProMed Pharma LLC, commented: \"We are proud to support CRISM Therapeutics in the GMP manufacture of ChemoSeed for their innovative glioblastoma program. Our team is committed to ensuring ti...