Cell Therapy pioneer TiGenix has announced positive interim safety results of its Phase IIa study of its allogeneic stem cell therapy Cx611 in rheumatoid arthritis (RA), showing a good safety profile at all three doses of the product that were administered in the trial.
This is a significant development in the field of stem cell therapy because Cx611 is an allogeneic product that potentially could be made available off-the-shelf and used to treat any patient, without concerns that the foreign cells will cause an immune reaction. In addition, TiGenix says the product, which is made from adult stem cells derived from human adipose (fat) tissue, has a broad anti-inflammatory effect and could also be used to treat other autoimmune disorders.
If positive, the final results of the trial, due in April 2013, will set the scene for the further development of Cx611. The TiGenix trial is the most advanced in the world using stem cells to treat rheumatoid arthritis. Along with other cell therapies that are advancing in development such as ReNeuron plc’s neuronal cell therapy for treating the after-effects of stroke, and the human embryonic stem cell-based treatment for macular degeneration (a major cause of blindness) which Pfizer is developing in collaboration with scientists at University College London, the TiGenix news on Cx611 underlines Europe’s leading position in cell therapy and regenerative medicine.
These three products can all trace their origins back to publicly-funded basic research, providing a potent demonstration of the importance of continuing to support academic research in the field, and of building and reinforcing the clinical and regulatory framework for translating this research into commercial products.
Moves by some MEPs to end European Union funding for embryonic stem cell research in the proposed €80 billion Horizon 2020 R&D programme are widely seen as a threat to Europe’s standing in cell therapy and regenerative medicine. Science|Business brought together experts from patients’ groups, research charities, academe, industry, science and economic policy, and regulators, to discuss the implications of an end to EU support for embryonic stem cell research, and scope what needs to be done to build the regenerative medicines market in Europe, to the benefit of patients and the economy. The full report is now available here.