Rexgenero starts phase III program with REX-001 for CLI treatment

REX-001 has been shown to trigger the growth of new blood vessels to replenish blood supply to the limb, reduce symptoms and boost quality of life of patients suffering from CLI.

The cell therapy’s phase 3 program will consist of two placebo-controlled, double-blind, adaptive phase 3 trials in patients with CLI and DM.

One trial has patients with Rutherford stage 4 CLI enrolled in it to evaluate the efficacy and safety of REX-001 with complete relief of ischemic rest pain being its primary endpoint.

The other trial will evaluate the efficacy and safety of the drug in patients with Rutherford stage 5 CLI with complete ulcer healing being its primary endpoint.

For both the late-stage trials, amputation-free survival has been defined as one of the secondary endpoints.

Rexgenero intends to have a total of 138 patients participating in the phase 3 program at about 35 clinical sites across Europe. The company expects to release first interim results in about 18 months’ time and full data in 2020.

Rexgenero CEO Joe Dupere said: “We are extremely pleased to announce the first patient infusion in our Phase III programme with REX-001, which if successful could significantly improve the treatment of patients with CLI.

“The programme has been designed following advice from the EMA and in close collaboration with our Scientific Advisory Board. CLI is a medical condition with a clear need for new improved treatment options.”

Earlier this week, Rexgenero had secured £1.4m in funding from Innovate UK alongside its project consortium partners for a £1.8m project. 

The research project will aim to design a cost-effective manufacturing strategy for REX-001 over a period of 21 months.

Image: Rexgenero’s autologous cell therapy REX-001 for CLI is being evaluated in two phase 3 clinical trials. Photo: courtesy of jk1991/FreeDigitalPhotos.net.