TrivarX Engages CRO for Stabl-Im Phase 1 Safety Trial

Company News

by Finance News Network


TrivarX Limited (ASX: TRI), a healthcare technology company focused on developing innovative diagnostic and imaging solutions across mental health and neuro-oncology, has announced a significant step forward in the clinical development of its Stabl-Im imaging technology. The company has engaged Beyond Drug Development, a specialist Contract Research Organisation (CRO), to support the progression of its planned Phase 1 safety trial for Stabl-Im. This engagement marks an important milestone in advancing the proprietary platform towards clinical evaluation.

Stabl-Im is TrivarX’s proprietary MRI-based functional imaging platform designed to visualise actively replicating tumour cells using stable isotopes, thereby eliminating the need for radioactive tracers. This technology aims to provide earlier and more biologically meaningful insights into tumour activity, cellular proliferation, and treatment response, leveraging existing MRI infrastructure for a potentially safer, more accessible, and operationally streamlined alternative to traditional imaging techniques in oncology. The proposed Phase 1 study will be an open-label sequential-cohort trial, evaluating the safety and tolerability of Stabl-Im in healthy volunteers following oral dosing.

Beyond Drug Development brings extensive expertise in early-phase clinical development, regulatory strategy, and imaging product advancement, with team members averaging more than 20 years’ experience in the field. The initial scope of their engagement will focus on completing the Phase 1 clinical protocol, preparing supporting clinical and regulatory documentation, and facilitating clinical site selection activities for the planned study. TrivarX is targeting the commencement of this crucial Phase 1 safety study during the second half of calendar year 2026, positioning Stabl-Im for future Phase 2 efficacy studies and broader clinical imaging applications.


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