Rexgenero Announces Positive Outcome of Independent Data Monitoring Committee Meeting for Phase III Trial for Diabetic Patients with Critical Limb-Threatening Ischaemia
Retrieved on:
Monday, October 26, 2020
Biotechnology, Diabetes, Health, Pharmaceutical, Clinical trials, Clinical research, Health sciences, Medical research, Health, Pharmaceutical industry, Design of experiments, Clinical trials, Drug discovery, Placebo-controlled study, Patient recruitment, Placebo, Rexgenero, REX-001 and the Phase III SALAMANDER clinical trials
Rexgenero, a regenerative medicine company developing advanced cell therapies to treat critical limb-threatening ischaemia (CLI), today announces that the Independent Data Monitoring Committee (IDMC) for its REX-001 phase III clinical trial recently met to review patient safety and tolerability data from the initial 22 subjects.
Key Points:
- Rexgenero, a regenerative medicine company developing advanced cell therapies to treat critical limb-threatening ischaemia (CLI), today announces that the Independent Data Monitoring Committee (IDMC) for its REX-001 phase III clinical trial recently met to review patient safety and tolerability data from the initial 22 subjects.
- We are pleased to receive the IDMCs recommendation that our REX-001 phase III clinical study should continue without any protocol modifications.
- Despite the unprecedented challenges of the COVID-19 pandemic, we believe we are back on track in terms of patient recruitment and moving the REX-001 phase III trial forward.
- The phase III study is a pivotal, placebo-controlled, double-blind, parallel-group, adaptive trial conducted in subjects with diabetes and Rutherford Category 5 CLI.