Positive interim analysis of safety and efficacy from the first 30% of enrolled patients evaluated 12 months post-treatment in a Phase 3 clinical trial (SALAMANDER) of REX-001 has resulted in the independent Data Monitoring Committee (DMC) recommending the unchanged continuation of the trial. REX-001, an autologous multi-cell therapy (MCT), is being developed for the treatment of chronic limb-threatening ischaemia (CLTI) in diabetic patients and is the furthest advanced product in this indication.
Ixaka’s placebo-controlled Phase 3 clinical trial (SALAMANDER) evaluating the safety and efficacy of REX-001, a drug candidate targeted towards patients with chronic limb-threatening ischemia (CLTI) and diabetes, has demonstrated positive interim results at 12 months after treatment.
The independent Data Monitoring Committee (DMC) recommended that the trial continue unchanged after assessing interim data from the first 30% of enrolled patients. This confirms that REX-001 is an effective and safe treatment for CLTI and that it is consistent with results from previous clinical trials showing over 70% ulcer healing in patients treated with the medicine. Enrolment in the trial is accelerating, with over 50% of patients already treated, and the trial includes two planned interim analyses after 30% and 50% of enrolled patients have hit 12 months post-treatment.
REX-001 is an autologous multi-cell therapy (MCT) in clinical development as a patient-specific cellular immunotherapy, and is the furthest advanced product in this indication. It is produced from cells extracted from a patient’s own bone marrow, that are then enriched for white blood cells and re-administered into the affected limb to deliver immune and progenitor cells into the diseased vessels.
“With such poor treatment options available and the high number of patients affected, this is a significant milestone in this devastating disease. The positive interim analysis confirms the potential of REX-001 as an effective treatment of the disease,” commented Joe Dupere, CEO at Ixaka.
Gilbert Wagener, Senior Vice President and Chief Medical Officer at Ixaka, added that “[t]he 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 authorization l.”
The SALAMANDER trial, following a Phase 2 trial demonstrating complete ulcer healing in 75% of treated patients, is a randomised double-blind placebo-controlled adaptive trial including diabetic patients with Rutherford category 5 CLTI. The primary endpoint is complete ulcer healing.
Ixaka Ltd is an integrated cell and gene therapy company that uses the body’s natural powers to cure disease by enhancing the naturally therapeutic power of cells by increasing the presence of curative cells at the site of disease, or by directly modifying cells within the body to improve disease targeting and boost their restorative effect. The company’s technologies could potentially treat a series of serious diseases. For more information, visit www.ixaka.com.