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Genkyotex Announces Update for Near Term Clinical Development Plan for Setanaxib


Genkyotex Announces Update for Near Term Clinical Development Plan for Setanaxib
(Paris:GKTX) (Brussels:GKTX)
(Euronext Paris Brussels: FR0013399474 GKTX), a biopharmaceutical company and the leader in NOX therapies, today announced clinical and governance updates.
Clinical update
Following the positive results from the Phase 1 study announced in January of 2021, which evaluated higher doses of setanaxib in healthy subjects, Genkyotex is planning to initiate a pivotal Phase 2/3 study in primary biliary cholangitis (PBC), starting in the 2
nd half of 2021, with final design and protocol details subject to feedback from the US Food and Drug Administration (FDA).
In addition, the Company plans to initiate this year a Phase 2 proof-of-concept study in patients with head and neck cancer. The trial will evaluate administration of setanaxib, targeting cancer associated fibroblasts (CAFs), in conjunction with immunotherapy. ....

United States , Bruxelles Capitale , Elias Papatheodorou , Philippe Wiesel , Alexandre Grassin , Victor Thannickal , United States National Institutes Of Health , Serum Institute , Drug Administration , University Of Alabama At Birmingham , Regulatory News , Euronext Paris Brussels , Executive Vice President , Chief Medical Officer , Calliditas Therapeutics , Euronext Paris , Euronext Brussels , Kidney Disease , United States National Institutes , Professor Victor Thannickal , India Private Ltd , ஒன்றுபட்டது மாநிலங்களில் , ப்ரூக்ஸெல்ஸ் தலைநகரம் , ஒன்றுபட்டது மாநிலங்களில் தேசிய நிறுவனங்கள் ஆஃப் ஆரோக்கியம் , சீரம் நிறுவனம் , பல்கலைக்கழகம் ஆஃப் அலபாமா இல் பர்மிங்காம் ,