London, UK-based Rexgenero has reached a major milestone in treating the first patient in a late-stage trial with its lead product, cell therapy REX-001.

The company is assessing the therapy’s potential in treating Critical Limb Ischemia (CLI) - a severe obstruction of the arteries that significantly reduces blood flow to the extremities, causing severe pain, skin ulcers or sores – in patients with diabetes.

REX-001 has been shown to stimulate the growth of new blood vessels to restore blood supply to the limb, alleviate symptoms and improve quality of life of patients with CLI.

Rexgenero is carrying out two pivotal, placebo-controlled, double-blind, adaptive Phase III trials in patients with CLI and diabetes, which were designed with advice from the EMA

One will include patients with stage 4 CLI and will assess the efficacy and safety of REX-001 with a primary endpoint of complete relief of ischemic rest pain.

The second will evaluate the therapy in patients with stage 5 CLI, with a primary endpoint of complete ulcer healing. Amputation-free survival is also a secondary endpoint in both studies.

The company is intending to enrol 138 patients at around 35 clinical sites across Europe, with first interim results expected in approximately 18 months’ time and full data in 2020.

“CLI is a medical condition with a clear need for new improved treatment options,” said Joe Dupere, Rexgenero’s chief executive. “Our goal is to bring innovative cell, gene and tissue therapies to the market addressing high unmet needs which cannot be treated with available therapies. We believe that REX-001 has the potential to be one of the first effective cell therapy products available for patients with CLI.”

The news came just days after the firm announced it had won a £1.4 million grant from Innovate UK for research project aiming to design a cost-effective manufacturing strategy for the therapy over a 21-month period.

Rexgenero will work alongside the Cell and Gene Therapy (CGT) Catapult, TrakCel and Fisher Bioservices (part of Thermo Fisher Scientific) on the project.