Date: 2015-12-10
Type of information: Grant
Company: TETRA consortium lead by Videregen (UK)
Investors: European Commission’s Horizon 2020 programme
Amount: € 6.8 million
Funding type: grant
Planned used: The pan-European TETRA consortium will use the funds for a pivotal Phase II clinical trial of Videregen's tissue engineered replacement trachea. The project will start at the beginning of 2016 with the first patients to be treated in 2017, building on the results of the four-patient UK INSPIRE Phase I study. The study will focus on the orphan indication of severe structural airway disease (SSAD). The pivotal trial results are expected to lead to a European Marketing Authorisation application in 2019, with launch of the world's first commercially available tissue engineered organ replacement product in 2020. The Phase II trial will recruit patients from five clinical sites across Europe and the study is to assess the safety and efficacy of the replacement trachea product. It will monitor how treatment reduces patients' need for additional interventions such as stents, as well as other factors such as impact on quality of life. The project also involves scale-out of stem cell manufacture from the UCL/Royal Free Hospital London Centre for Cell, Gene and Tissue Therapeutics to establish a second GMP manufacturing site in Munich, creating a pan-European supply chain. Validation of this production and supply system is an objective of the trial, as is demonstration of the product to patients and leading surgeons.
Others: * On December 10, 2015, the pan-European TETRA consortium, led by Videregen Limited, has been awarded € 6.8 million under the Horizon 2020 programme for a pivotal Phase II clinical trial of the company's tissue engineered replacement trachea. The 13-partner TETRA consortium brings together cross-disciplinary expertise in the areas of regenerative medicine, tracheal diseases and airway disorders, clinical trials and cell-based tissue engineered product manufacture. The principal investigator is Professor Martin Birchall (UCL, UCL Hospital NHS Foundation Trust) with additional trial sites at the University of Manchester/University Hospital of South Manchester NHS Foundation Trust (UK), Università degli studi di Brescia (Italy), Medical University of Vienna (Austria) and Instytut Gruzlicy I Chorob Pluc (Poland). Other parties include the Cell Therapy Catapult (pan-European regulatory processes and lead clinical research activities), TMC Pharma (regulatory affairs and lead clinical research activities), NHS Blood and Transplant (tissue retrieval and trachea scaffold manufacture), Klinikum Rechts der Isar der Technischen Universität München (stem cell processing and final product release) and Euram (project management).
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