Rexgenero presented an update on its two Phase III SALAMANDER trials being conducted across Europe for its cell-based therapy, REX-001, which aims to treat critical limb ischaemia (CLI) in diabetic patients.
During Rexgenero’s presentation at the Cell and Gene Therapy Meeting in Barcelona, organised by the Alliance for Regenerative Medicine, Joe Dupere, CEO provided an update on the Phase III trial of REX-001. Twelve 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.
CLI is a condition in which blood and oxygen flow is impaired to a limb; often caused by the build up of plaques or other forms of damage to arteries. It is most common in type 2 diabetics, and often leads to limb amputation due to uncontrolled hyperglycemia in type 2 diabetes.
REX-001 is created from 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”*. Rexgenero is planning to treat 138 patients in two Phase III SALAMANDER trials. The therapy works by supporting existing blood vessels, and stimulating the formation of new vessels. In addition, it appears to have some positive effects on diabetic ulcers.
*= the editor cannot find any evidence of a phase I/II trial to confirm the claim of “80% improvement”.
For more information about the SALAMANDER trial, please visit Rexgenero’s page.