The 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.

20 December 2024

CRISM Therapeutics Corporation

("CRISM", "CRISM Therapeutics" or the "Company")

Appointment of Specialist Clinical CRO

CRISM Therapeutics Corporation (AIM: CRTX), the innovative UK drug delivery company focused on the localised delivery of chemotherapy drugs, announces that it has appointed Aixial Group ("Aixial"), a specialist clinical contract research organisation ("CRO") to progress the Company's Clinical Trial Authorisation ("CTA") application.

CRISM appointed Aixial, an international CRO, to progress and finalise the Company's CTA application for the Company's open label Phase 2 study of ChemoSeed in patients with glioblastoma. 

Glioblastoma, a rare disease, is the most aggressive form of brain tumour with a median overall survival of just 14.6 months, making it an area of major unmet medical need.  

Aixial has significant experience of rare diseases and brain tumour trials, both in the UK and internationally, and has delivered more than 300 oncology studies across multiple jurisdictions including the UK, EU, USA and Asia Pacific. The Board considers that Aixial is best suited to serve CRISM's requirements for an accelerated CTA application and approval and they are currently in discussions with the Medicines and Healthcare products Regulatory Agency ("MHRA") to obtain scientific advice prior to the submission of the Company's Clinical Trial Application for the Phase 2 study, scheduled for early 2025.

The appointment of Aixial also brings the potential for study centres outside of the UK to be included in the Phase 2 study, which would be of great value in assisting patient recruitment and in the subsequent commercial pathway should the study be successful.

The Company continues to work closely with the University of Birmingham and the Tessa Jowell BRAIN MATRIX scientific advisory committee is supportive of the clinical evaluation of ChemoSeed in patients with primary brain cancer and will promote the clinical trial to patients via their network. 

Commenting on the appointment of Aixial, CRISM CEO Andrew Webb said: "We are delighted to be working with a well-established CRO like Aixial on our CTA application.  Operating across multiple jurisdictions and with expertise in rare diseases such as glioblastoma we believe that Aixial is the ideal strategic partner for CRISM.  We would like to thank the University of Birmingham for its support and look forward to continuing collaborating with the Tessa Jowell BRAIN MATRIX."

Commenting on the agreement, Aixial Managing Director, Jonas Möller said: "Aixial Group take great pride in our extensive glioblastoma experience. Our partnership with CRISM Therapeutics is a testament of our commitment to advancing oncology research and our ability to support innovative and impactful treatments such as ChemoSeed. 

"Leveraging the expertise of our operations teams and glioblastoma subject matter experts, including Dr. Valentina Zhukova-Harrill, Chief Medical Officer, we ensure every trial is grounded in robust medical, operational, and regulatory excellence. Aixial's deep understanding of complex oncology studies strengthens our ability to deliver high-quality solutions for our partners and, most importantly, for patients."

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Enquiries:

About Aixial Group

Aixial Group is a Contract Research Organization (CRO) with over 25 years of experience, dedicated to delivering high-quality clinical research solutions globally. We provide comprehensive support for clinical trials, with specialized expertise in Oncology, Rare Diseases, and Central Nervous System (CNS) disorders.

For more information please visit: https://www.aixialgroup.com/

About CRISM Therapeutics Corporation

CRISM Therapeutics Corporation has developed an innovative drug delivery technology to improve the clinical performance of cancer treatments for solid tumours through the local delivery of chemotherapy drugs.

ChemoSeed®, CRISM's lead product, can be implanted directly into the tumour or the resection margin following the removal of a tumour. This directs that therapeutic concentrations of chemotherapy drugs reach the deep-seated tumour tissue or cover the entire resection margin. In the case of treating high-grade glioma, ChemoSeeds can be implanted during surgery thereby bypassing the blood brain barrier, which prevents other treatments from being able to reach the tumour and be effective.

CRISM is scheduled to submit a clinical trial application for ChemoSeed in high-grade glioma in early 2025. 

For more information please visit: https://www.crismtherapeutics.com/