London-headquartered cell and gene therapy company Ixaka has announced positive interim data for its lead multi-cell therapy (MCT) REX-001 from a Phase III clinical trial.
The trial evaluated the safety and efficacy results 12 months after treatment with REX-001 or placebo in patients with chronic limb-threatening ischaemia (CLTI) and diabetes.
The independent data monitoring committee (DMC) has recommended continuation of the trial following an assessment of the interim efficacy and safety data.
The DMC confirmed that the expected effect of REX-001 compared to placebo in the late-stage trial is ‘on track’, with the benefit-risk profile being ‘acceptable’ and no significant safety concerns.
In previous clinical trials, treatment with REX-001 resulted in complete ulcer healing in over 70% of patients, Ixaka said in a statement.
REX-001 is produced using cells taken from a patient’s own bone marrow and enriched for white blood cells – it is then re-administered into the affected limb, delivering multiple immune and progenitor cells directly to the diseased vessels to address the processes that lead to clinical progression of CLTI.
“This first Phase 3 interim analysis is a critical milestone for our lead cell therapy candidate REX-001. The positive benefit-risk evaluation by the DMC provides reassurance that REX-001 is an effective and safe treatment for CLTI, and that it is on the right path towards marketing authorisation,” said Gilbert Wagener, senior vice [resident, chief medical officer at Ixaka.
“Based on these results, I am confident that we can provide our innovative and much-needed product to patients suffering from CLTI in the near future,” he added.