New update on Phase III clinical trials of REX-001 cell-based therapy for critical limb ischaemia


Rexgenero, a regenerative medicine company working to develop cell-based therapies to treat critical limb ischaemia (CLI), has presented an update on its two Phase III SALAMANDER trials being conducted across Europe for its lead development programme REX-001 to treat CLI in patients with diabetes.

During Rexgenero’s presentation at the Cell and Gene Therapy Meeting on the Med (23–25 April, Barcelona, Spain), organised by the Alliance for Regenerative Medicine (ARM), Joe Dupere provided an update on the Phase III programme with REX-001. Dupere, who is CEO of Rexgenero, announced that 12 of the 25 planned trial sites are now open and treating patients in Spain, Austria, Portugal, Poland, Czech Republic, and Hungary, with additional hospitals expected to be initiated by the end of the year in three additional countries.

REX-001 consists of bone marrow-derived white blood cells extracted from the patient (autologous) and has shown efficacy in 80% of patients in Phase II and I/II studies. The company is planning to treat 138 patients in two Phase III SALAMANDER trials. The presentation highlighted encouraging clinical improvements in two patients treated in Spain with REX-001 out of protocol, as they did not meet the trial criteria.

Commenting in a company press release, Dupere states: “We are at a hugely exciting time for the company and, more importantly, for patients with CLI, as our Phase III trial sites for REX-001 are now treating patients in many countries including Spain. With our Spanish heritage, the location of ARM’s Meeting on the Med is particularly significant for Rexgenero. We are on track to open further clinical trial sites across Europe.”


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