UK drug delivery company CRISM Therapeutics Corporation (AIM: CRTX) announced on Monday that it has received positive written scientific advice from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) regarding its clinical trial application (CTA) for ChemoSeed, a novel localised chemotherapy delivery system for high-grade glioma.

MHRA's feedback confirms that additional preclinical toxicology studies will not be required, saving CRISM an estimated GBP400,000 in development costs and expediting trial preparations. The agency also acknowledged the biological rationale behind ChemoSeed and the need for alternative treatment options. Additionally, MHRA endorsed CRISM's proposed dose escalation study design, affirming its suitability for a Phase 2 trial, while providing recommendations to enhance the clinical programme for potential market authorisation.

CRISM is incorporating these recommendations with guidance from Aixial, its contract research organisation, and its medical advisers. The CTA submission is expected in H1 2025, with clinical trials set to commence in Q4 2025, pending regulatory approvals.

To support trial funding, CRISM has engaged Ryan LLC, a specialist in securing grant funding, which has identified potential funding opportunities for ChemoSeed.

ChemoSeed, CRISM's lead product, enables direct implantation of chemotherapy drugs into tumours or resection margins, overcoming the blood-brain barrier to enhance treatment efficacy. The company remains on track to advance its clinical programme and explore market opportunities for its innovative drug delivery technology.