UK Cell Therapy Trial Database to Help Advance Trials to Later Stages
Launched by Cell Therapy Catapult, which is developed and funded by the UK government’s Technology Strategy Board, the database includes 21 cell therapy studies. The majority of trials in the database unveiled last week are Phase I and II focusing on cardiovascular, neurological, transplant and oncology treatments. Stem cell transplants and gene therapy delivery systems are excluded.
“There's long been recognition that there is a lot of cell therapy expertise in the UK,” Catapult spokeswoman Emma Palmer Foster told Outsourcing-Pharma.com. However, there is “a dearth of later-stage clinical trials and therapies coming through to the market” and Catapult aims “to tackle this late-stage translational gap…in order to carry out clinical trials, provide manufacturing and regulatory expertise, and access to finance and medical expertise.”
Cell Medica’s T cell therapy for the cytomegalovirus immunity for post-bone marrow transplantion is the only trial in the current database that is solely a Phase III trial.
Later in 2013, Catapult will publish a database of cell therapies likely to enter clinical development in the next few years. The database will be updated regularly and the cell therapy community can input more data in order to ensure it remains comprehensive and accurate.
“We're really pleased with the response of the community to the database - both in terms of compiling and validating it, and since it's been released,” Foster said.
The UK’s Technology Strategy Board is committed to investing up to about $16.5M annually to Catapult to aid its “5 year business plan of activity including pilot projects to support cell therapy development as well as support activities to enable the sector in the UK,” Nick Sheppard, a spokesman of the board, told Outsourcing-Pharma.com.
EU Trial Data
The launch of the cell therapy database comes as the UK government health committee calls for all trial data to be public, as well as EMA efforts from October to publish clinical trial data publically. EMA guidance focuses on the ways in which trial sponsors and pharma manufacturers should post trial data to the EudraCT database. The guidance is mostly in line with the U.S. Food and Drug Administration’s ClinicalTrials.gov web site.
In July, the European Commission also adopted a new proposed regulation governing clinical trials that will make it easier to conduct multinational trials in Europe.
Foster noted the difference between the Catapult initiative and the commission’s regulation. “Catapult's database is focused on the UK and cell therapy specifically - it's a top-level summary of the state of the industry,” she said.
