GoLiver Therapeutics Receives a Positive Scientific Advice from the European Medicines Agency (EMA) on its Clinical Development and Biomanufacturing Strategy for Acute Liver Failure
This opinion corroborates the previous scientific advice from the UK Medicines and Healthcare Products Regulatory Agency (MHRA)
NANTES, FRANCE--(Business Wire / Korea Newswire) June 30, 2020 -- GoLiver Therapeutics, a start-up focused on the development of Innovative Therapy Medicines, in particular cell therapy products for life-threatening liver diseases without the need for transplant using differentiated pluripotent stem cells, announces that the European Medicines Agency (EMA) has given a positive scientific advice on its clinical development, pharmaco-toxicological and production strategy plans. With this positive scientific advice, GoLiver Therapeutics has reached an important milestone in its clinical roadmap.
The EMA thus confirms the positive scientific advice given in 2018 by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) on the manufacturing production, the pharmaco-toxicological assessment and the clinical development plans of GoLiver Therapeutics for its first pipeline product for the treatment of acute liver failure.
Currently, GoLiver Therapeutics is working with the Paul-Brousse Hospital (AP-HP, Villejuif, France) on the design and implementation of a Phase I/IIa clinical trial for acute liver failure.
“We are very pleased to have obtained this positive scientific advice despite the COVID-19 health crisis, and we thus remain in line with our clinical development and production plans towards the clinical trials. The EMA's recommendations will help us to obtain approval for clinical studies from the national health agencies in the European countries where the clinical study will be conducted. Our goal is to initiate as soon as possible the clinical evaluation of our first drug candidate, an injectable solution of frozen liver cells produced from pluripotent stem cells as regenerative treatment of severe liver failures having no live-saving treatment other than liver transplantation” said Tuan Nguyen, CEO of GoLiver Therapeutics.
About GoLiver Therapeutics - https://golivertx.com/
GoLiver Therapeutics is a spin-off created in 2017 from Inserm and the University of Nantes (CRTI UMR1064, ITUN, Nantes University Hospital Centre) focused on developing Advanced Therapy Medicinal Products (ATMPs) to meet a major medical need in liver transplantation. GoLiver Therapeutics aims to become a world leader in the regenerative medicine field by tackling liver regeneration, by conducting the first clinical studies and bringing the first innovative cell-based drug for treating liver diseases without the need for transplant by using the breakthrough technology of pluripotent stem cells.
Highlighted by Challenges magazine as one of the “100 start-ups to invest in” for 2019, GoLiver Therapeutics has been awarded the France French Transfer Invest 2019, the i-LAB 2016 national Grand Prize for health biotechs and i-LAB 2015 in the emerging start-ups category. Its R&D is supported by BPI France and European Union (ERDF) funding of €400,000 to develop the first stages of bioproduction process industrialization (2018-2020).
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