TFS International AB (TFS) appointed CRO representative for TIKOMED’s phase 2 study in clinical islet transplantation
Viken – 4th March 2019 – TIKOMED, a Swedish privately held biopharmaceutical company today announced the appointment of TFS to perform CRO services for TIKOMED’s Phase 2 study in clinical islet transplantation. The study is planned to be performed as an international multi-center study.
IBsolvMIR is TIKOMED’s immune modulating drug candidate currently in Phase 2 development. IBsolvMir addresses the instant blood-mediated inflammatory reaction (IBMIR) occurring as a reaction to islet cell transplantation in brittle diabetics. In both patient studies and pre-clinical work, IBsolvMIR has shown to be efficacious by decreasing graft loss and helping to establish the graft. TIKOMED is now starting a second Phase 2 study with IBsolvMIR for brittle diabetics, involving internationally renowned experts at multiple centers.
Adam Bruce – Executive Board Member and founder of TIKOMED, “We are very pleased to contract TFS for this study. TFS was the first CRO that we worked with in the islet transplantation program. TFS have shown to have the experience and organizational capabilities to be a reliable partner throughout this journey. We regard this study to be the first in a wider scope where we will show the benefits of IBsolvMIR in combinations addressing other therapeutic cells. Considering the present boom in advanced therapies, where FDA recently announced that they anticipate receiving 200 new INDs and approving 10-20 new therapies annually, the importance of finding competitive advantages through graft optimization such as with IBsolvMIR, may prove the difference between approval and failure.”
Janos Filakovský – CEO, TFS International AB, “TFS is an established global CRO with its roots in Sweden and TIKOMED was one of our early customers. Our collaboration with TIKOMED really shows that we are the clinical development partner of choice, for small and mid-sized life science companies. Our unique combination of local and global expertise, flexibility, processes and technology delivers excellence in every aspect of our customer’s clinical research journey. With a long-term commitment in growing our capabilities on a global scale, we look forward to working with TIKOMED in the exciting field of advanced therapies.”
TIKOMED is now preparing to expand the use of IBsolvMIR through partners in the quickly expanding field of gene- cell and advanced therapies.