FreeOx Biotech has taken on Xavier Luria as its new partner and strategy advisor in a bid to accelerate development and the regulatory process for its main drug candidate, Ox-01, to treat stroke.
Luria is a world-renowned expert in clinical and regulatory drug development. Since 2012, he has been an independent senior consultant in Drug Development and Regulation (DDR) with offices in Barcelona and London. He was head of Safety and Efficacy of Medicines at the European Medicines Agency (EMA) from 2005 to 2012, and previously held leadership positions in the biopharmaceutical industry for more than eighteen years, covering international clinical development, pharmacovigilance, biostatistics and medical affairs in Europe, Japan and USA. Currently, he is a lecturer at several academic institutions and Module Chair in a postgraduate course at King’s College London.
“Ox-01 has completed phase IIb with promising results for stroke, a disease that is very much in need of therapeutic options. We’re sure that, with Xavier Luria on the team, we will be able to consolidate this work and boost its value to make the product attractive to potential licensees,” explains Carlos Lurigados, co-founder and CEO of FreeOx Biotech.
For his part, Xavier Luria highlights: “Given its advanced stage of development, Ox-01 could become a real therapeutic option to treat stroke within a few years. To make this happen, DDR is collaborating to guide its advance in compliance with FDA and EMA regulatory criteria, and through ongoing communication with these agencies.”
Ox-01 is a powerful anti-oxidant drug that has been proven highly safe in 445 patients with stroke. It substantially improves the prognosis of important subgroups of patients with greater oxidative stress, such as women, patients with high glucose levels and those treated with mechanical embolectomy. The main researcher on the studies is Dr Angel Chamorro, head of the of the Functional Unit of Cerebral Vascular Pathology at Hospital Clinic Barcelona.