Our lead product REX-001 is a novel autologous cell therapy developed for the treatment of critical limb ischemia (CLI), a severe obstruction of the arteries that seriously decreases blood flow to the extremities causing severe recurrent pain, and non-healing ulcers affecting millions of patients in Europe and U.S. Following highly encouraging results from three phase II studies which completed in 2016, Rexgenero is conducting two pivotal, placebo-controlled, double-blind, adaptive Phase III trials in patients with CLI and Diabetes Mellitus (DM).
The design of both trials, including the patient population and primary endpoints, has been fully endorsed by the European Medicines Agency (EMA).
We are recruiting patients for two pivotal, placebo-controlled, double-blind, adaptive Phase III trials in patients with CLI and DM.
These studies are confirmatory Phase III clinical trials and their design have been endorsed by the European Medicines Agency (EMA) including the two primary endpoints:
– The Phase III study in patients with Rutherford stage 5 CLI will assess the efficacy and safety with a primary endpoint of complete ulcer healing.
– The Phase III study in patients with Rutherford stage 4 CLI will assess the efficacy and safety of REX-001 with a primary endpoint of complete relief of ischemic rest pain.
Amputation-free survival is included as a secondary endpoint in both studies.
The EMA has also confirmed that these two confirmatory studies would be sufficient for marketing authorisation
Both studies are expected to complete in late 2018.
Results from three phase II studies, which completed in 2016, and which saw REX-001 being administered to over 100 patients in three clinical trials, have been highly encouraging. Patients were classified according to the Rutherford scale in category 4 (rest pain without ulceration) or category 5 (ulcers). Following treatment with REX-001, after 12 months, most patients in both populations were free of CLI with significant improvement in their clinical condition (as assessed by change in Rutherford category) with complete ulcer healing and alleviation of rest pain.
Angiographic imaging was used to assess revascularisation following treatment with REX-001. In the majority of treated patients there was a major improvement in blood vessels in the limb, which is likely to be responsible for the corresponding improvement in patient’s clinical condition.
> Angiograms showing blood vessels prior to treatment (left) and after 6 months following treatment with REX-001 (right)
Patients with CLI often experience painful ischemic ulcers which may partially resolve with intensive wound management, but are rarely completely healed. Following treatment with REX-001, the majority of patients in the three Phase II studies with ulcers experienced complete or partial healing.
> Diabetic ulcer at baseline (left) and after 6 months following treatment with REX-001 (right)