Therapy Areas: Diabetes
Rexgenero Expands Manufacturing of REX-001 through Partnership with German Red Cross Blood Donor Service
29 May 2019 - - UK-based regenerative medicine company Rexgenero has expanded manufacturing of its lead development candidate REX-001 through a partnership with the German Red Cross Blood Donor Service in Frankfurt, Germany, signed earlier this year, the company said.

REX-001 is an autologous cell-based therapy and is manufactured using the patient's own bone marrow. It contains immune cells (lymphocytes, monocytes and granulocytes) and progenitor cells involved in immune modulation and tissue regeneration.

Manufacturing is time critical as it is important to ensure administration of the fresh product within 48 hours.

Successfully transferring the manufacturing technology to this second GMP facility in Europe is a key milestone to ensure sufficient supply to patients enrolled in Rexgenero's European Phase III SALAMANDER trials of REX-001 for the treatment of CLI in patients with diabetes.

REX-001 is already manufactured at Rexgenero's own GMP manufacturing facility in Seville, Spain and used predominantly at clinical trial sites in Spain and Portugal.

Under a manufacturing partnership, the German Red Cross Blood Donor Service will manufacture REX-001, principally for use at additional trial sites in Germany, Poland, Czech Republic, Hungary, The Netherlands, the UK and Austria.

However, both sites are able to manufacture and deliver product for most clinical sites within the limited time frame, ensuring manufacturing flexibility and backup possibilities.

The German Red Cross Blood Donor Service is one of the largest blood donor services in Europe and has significant expertise in GMP manufacturing of cell-based investigational medicinal products.

The manufacture of REX-001 is overseen by Professor Halvard Bönig, Institute for Transfusion Medicine and Immunohematology, Goethe-University and German Red Cross Blood Service Baden-Württemberg-Hessen, Frankfurt am Main, Germany.

REX-001 Phase III SALAMANDER clinical trials are open and recruiting patients at sites in Spain, Austria, Portugal, Poland, the Czech Republic, Hungary and The Netherlands.

Rexgenero is a clinical-stage regenerative medicine company developing innovative cell-based therapies targeting serious diseases with unmet medical needs.

The company's lead candidate REX-001, is a highly innovative autologous cell therapy that is being studied in a Phase III clinical programme in patients with critical limb ischemia with diabetes, a poorly treated disease with a high risk of amputation and death.

According to the company, REX-001 has been shown to be effective in Phase I/II and Phase II trials, alleviating CLI in the majority of patients, offering the potential to increase the quality of life of CLI patients by reducing pain, alleviating ulcers, increasing mobility, improving sleep and reducing the need for amputation.

Rexgenero is developing REX-001 in a range of indications and, pending approval, intends to launch and market this specialty product in major territories.

Rexgenero is a privately-owned company, which draws on an exceptional understanding of the fundamental science of cell therapies developed by the Andalusian Health Authority (Servicio Andaluz de Salud) and Andalusian Initiative of Advanced Therapies.

The company was founded in 2015 and is headquartered in London with R and D and manufacturing operations in Seville (Spain) and Frankfurt (Germany).

Rexgenero is planning to treat a total of 60 patients with CLI and rest pain and 78 patients with CLI and non-healing ischemic ulcers in two independent Phase III SALAMANDER trials in approximately 30 hospitals across Europe.

Clinical trials sites are open and recruiting patients in Spain, Austria, Portugal, Poland, the Czech Republic, Hungary and The Netherlands. The trials are given the name SALAMANDER in reference to the amphibian's ability to regenerate its tail and limbs.

The German Red Cross Blood Donor Service Baden-Württemberg-Hessen is one of the world's largest blood and transfusion medicine services. As a research-oriented pharmaceutical manufacturer, BSD is heavily invested in ATMP development and manufacturing, in collaboration with both academic and commercial entities.
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