CRISM Therapeutics Corporation has partnered with Aixial Group, a specialist clinical contract research organization (CRO), to advance the Clinical Trial Authorisation (CTA) application for its Phase 2 study of ChemoSeed in patients with glioblastoma. The collaboration aims to expedite the CTA process and potentially include international study centers, enhancing patient recruitment and commercial prospects.
Addressing Glioblastoma's Unmet Needs
Glioblastoma, a rare and aggressive form of brain tumor, presents a significant challenge with a median overall survival of just 14.6 months. This unmet medical need drives the urgency for innovative treatments like ChemoSeed, which is designed for direct implantation into tumors or resection margins, bypassing the blood-brain barrier to effectively deliver chemotherapy drugs.
Aixial's Expertise in Rare Diseases and Oncology
Aixial brings extensive experience in rare diseases and brain tumor trials, having delivered over 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. Jonas Möller, Aixial Managing Director, stated, "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."
ChemoSeed's Potential and Clinical Trial Plans
CRISM is scheduled to submit a clinical trial application for ChemoSeed in high-grade glioma in 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.
Collaboration with University of Birmingham and Tessa Jowell BRAIN MATRIX
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. CRISM CEO Andrew Webb commented, "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."
