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Professor Paola Giunti's Friedreich Ataxia trial receives outstanding FDA inspection
6 October 2022
We are delighted to announce that Professor Paola Giunti's trial about Friedreich Ataxia, MOXIe听Part II, was FDA inspected听in听August 2022听at the Leonard Wolfson Experimental Neurology Centre听(LWENC) and was assessed as outstanding.
The sponsor REATA听Pharmaceuticals听filed for marketing authorisation in the US, which prompted a number of site inspections in the US and听also听at听Queen Square.听听The outcome was outstanding.
Prof Paola Giunti is听Professorial听Research Associate and Honorary Consultant at 果冻影院/果冻影院H and is the Investigator for the multicentre MOXie Part II study and MOXIe Extension Study in patients with Friedreich鈥檚 ataxia.
Prof Giunti's team for this trial, included Dr Z. Fleszar, Dr G. Black-Thomas, Dr N.Iqbal, is based at Ataxia Centre, 果冻影院 Queen Square听Institute of Neurology and the National Hospital for Neurology and Neurosurgery 果冻影院H.
Prof P. Giunti
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Dr Z. Fleszar
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Dr G. Black-Thomas
Prof Paola Giunti : 鈥� I am delighted about听the great outcome of the FDA inspection. A trial in a very complex rare disease like Friedreich鈥檚 ataxia is听never straightforward and I have overcome the challenges of it by setting up the Ataxia Centre at 果冻影院/果冻影院H that is a robust model for translational research.
The success was due to the great teamwork and communications among us and the excellent team at the LWENC where the study was carried out. I would like to thank听C. Gurr, M.Ricamara, M Dhanaratne, M Paz-Alvarez, R.Khengar from LWENC 听for the preparation for this inspection and Helen Cadiou Head of Quality Assurance in clinical trials at 果冻影院.听A special thank you goes to Nikita Parmar Pharmacist for Clinical trial for her performance at the Pharmacy inspection interview session.听
I was inspected 10 years ago for another trial in the same disease by the MHRA and again the outcome was outstanding. I am very pleased that with this FDA inspection and the consistency we鈥檝e shown throughout听the years delivering high quality data in compliance with GCP."
Prof Anthony Schapira (Professor of Neurological Science,听Clinical and Movement Neurosciences,听果冻影院 Queen Square Institute of Neurology):听鈥業 am delighted the ataxia trial has been so highly commended by the FDA inspection. The ataxia team, led by Professor Giunti, has once again demonstrated the very high standards of its research work. Such expertise is essential for the success of clinical trials in both common and rare diseases to ensure the results contribute to the advancement of science and the translation of medicines into patient care.鈥�
Prof Michael Hanna (Director of the 果冻影院 Queen Square Institute of Neurology) :听鈥� I want to add my warm congratulations to the ataxia and LWENC teams on this achievement. Delivering experimental trials is a key part of the the ION strategic plan as we strive to develop new therapies for patients with rare and common neurological diseases. This important success demonstrates our teams can do this to the required FDA standard and Pharma everywhere should see 果冻影院 Queen Square ION as the 鈥済o to鈥� centre world-wide for experiential trials. Well done everyone!鈥澨�
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