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Catalent, Cerenis Initiate Phase III Trial of CER-001

Will leverage Catalent’s GPEx cell line technology for trials in Europe and NA

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Cerenis Therapeutics has advanced its leading clinical candidate, CER-001, into Phase III clinical studies across Europe and North America using Catalent Biologics’ GPEx cell line technology. The phase III TANGO trial was initiated in October 2015, to evaluate efficacy to regress atherosclerosis, and safety of CER-001 in patients with Familial Primary HypoalphAlipoproteinemia (FPHA). Cerenis Therapeutics’ CER-001 candidate is an engineered complex of recombinant human apoA-I, the major struct...

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