Business
Clinical Trial Update
Clinical Trial Update.
About this update from Crism Therapeutics Corporation
[{"type":"text","content":"\n\nThe information contained within this announcement is deemed to constitute inside information as stipulated under the Market Abuse Regulation (EU) No. 596/2014, as incorporated into UK law by the European Union (Withdrawal) Act 2018. Upon the publication of this announcement, this inside information is now considered to be in the public domain.\n \n \n31 March 2025\n \n\n \nCRISM Therapeutics Corporation\n(\"CRISM\", \"CRISM Therapeutics\" or the \"Company\")\n \nClinical Trial Update\n \nCRISM Therapeutics Corporation (AIM: CRTX), the innovative UK drug delivery company focused on the localised delivery of chemotherapy drugs, provides a positive update regarding its clinical trial authorisation (\"CTA\") application to evaluate irinotecan ChemoSeed (\"ChemoSeed\") in patients with high grade glioma. CRISM has been working with the Medicines and Healthcare products Regulatory Agency (\"MHRA\") to finalise the design of the first in-human trial of ChemoSeed and is pleased to confirm it has received positive written scientific advice from the MHRA on the development, clinical trial programme and potential Market Authorisation Application for the commercialisation of ChemoSeed.\nThe written advice confirms that further preclinical toxicology studies will not be required, which will significantly reduce the cost and time of the development work. The Company had previously estimated a cost of approximately £400,000 to conduct the toxicology studies. \nIn addition, the MHRA agreed that there is a biological basis supporting the benefits of ChemoSeed and that more drugs and methods of delivery are needed for this disease. MHRA was supportive of CRISM's novel dose escalation study for ChemoSeed, confirming that the trial design was appropriate for a Phase 2 clinical trial. The MHRA provided recommendations to improve aspects of the clinical trial to make it more suited to achieving potential market authorisation. The Company is now progressing these recommendations, with support and advice from its contract research organisation, Aixial, and its medical advisers. The Company expects to finalise its CTA application for submission in H1 2025 and to begin clinical trials of ChemoSeed in Q4 2025, subject to MHRA and other external regulato...