Rexgenero is a leading regenerative medicine company and developer of advanced cell-based therapeutics for the treatment of serious diseases that are poorly treated with existing therapies. We are conducting clinical trials with our cellular therapies with the intention of obtaining marketing authorization in Europe, the United States and other markets.
Our lead candidate REX-001 is a highly innovative autologous cell therapy that is being studied in two Phase III clinical trials in patients with Critical Limb Ischemia (CLI) with diabetes. CLI is a poorly treated disease with approx. 25% of patients requiring amputation of the affected limb and the mortality rate of patients diagnosed with CLI is of 20-25% in the first year. The Phase III clinical studies aim to confirm the highly encouraging results seen in three Phase II trials where the majority of patients experienced a significant improvement in their clinical condition following treatment with REX-001.
Our treatments draw on an exceptional understanding of the fundamental science of cell therapies. Our current cell therapies have been developed by the Andalusian Health Authority (Servicio Andaluz de Salud) and Andalusian Initiative of Advanced Therapies and we aim to work with them to develop further cell therapies to treat other indications with high unmet medical needs.
Cellular therapies have the potential to successfully treat serious vascular, neurological and other disorders. Rexgenero’s technologies engineer naturally occurring stem cells so that they are able to regenerate diseased tissues.
In our clinical programs we are investigating the effectiveness of our therapies in :
• diabetic patients with peripheral arterial disease (PAD) and associated critical limb ischemia (CLI)
• non-diabetic patients with PAD and associated CLI
Our clinical candidate therapies use three different cellular technologies: bone marrow-derived mononuclear cells (BM-MNC), adipose derived mesenchymal stem cells (MSC) and bone marrow-derived CD133+ cells.
Our lead product REX-001, currently in phase III for CLI in diabetic patients, has shown substantial improvements over standard-of-care reversing the condition, alleviating intractable pain and non-healing ulcers and also addresses the underlying loss of blood vessels and tissue ischemia. . REX-001 has the potential to be effective even in patients where conventional revascularisation is not possible often leading to amputation. REX-001 has the potential to provide a substantial quality of life benefit to patients while significantly reducing the healthcare cost.