Ixaka's cell therapy clears early phase 3 data review

Cells derived from bone marrow have shown some promise in the treatment of patients with badly blocked arteries over the past 20 years without ever landing a knockout blow on the condition. Now, Ixaka has edged closer to showing if its prospect REX-001 can buck the trend by coming through an interim data analysis.

REX-001 is an autologous bone-marrow-derived cell suspension enriched for white blood cells. By administering the mix of progenitor and immune cells to patients with severe blockage in the arteries of their legs and feet, a condition known as critical limb ischemia (CLI), Ixaka hopes to tackle the plaque deposition, inflammation and other processes that drive the progression of the disease. 

Ixaka, the biotech formerly known as Rexgenero, is testing that hypothesis in a clinical trial that is enrolling 78 patients with CLI and randomizing them to receive an infusion of REX-001 or placebo into the low leg arteries. With 12-month results available for 30% of the patients, the data monitoring committee did unblinded prespecified safety and efficacy analyses and recommended the continuation of the trial without any changes.

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Ixaka is yet to see the unblinded data but said the interim analysis “is consistent with the effect observed in previous clinical trials, where treatment with REX-001 resulted in complete ulcer healing in over 70% of patients.” A second interim analysis is planned for when 12-month data on half of the participants are available. 

In an earlier phase 2 clinical trial, 75% of subjects on REX-001 experienced complete ulcer healing, compared to 14% of their peers in the control group. The finding emboldened Ixaka to move into the phase 3 study. ClinicalTrials.gov lists the estimated primary completion date for the phase 3 study at the end of April 2022.