30 November 2018

TIKOMED Granted Permission for Phase 2 Clinical Trial in Islet Cell Transplantation by the Swedish Medical Product Agency

VIKEN, Sweden, November 19, 2018 (Newswire) -TIKOMED, a specialty pharmaceutical company developing IBsolvMIR, an infusion product for improving outcome in cell transplantation announced today that it was granted approval for a clinical trial (Phase 2) in Islet Cell Transplantation to be performed in collaboration with Karolinska University Hospital and Uppsala University Hospital by the Swedish Medical Product Agency.

With Dr. Torbjörn Lundgren, as principal investigator, the clinical trial is conducted at and in collaboration with Uppsala University Hospital, Uppsala and Karolinska University Hospital, Stockholm. The study will include 18 patients who will receive one bolous dose to prevent IBMIR and three follow-up doses to enhance engraftment.

Torbjörn Lundgren, M.D, Phd, Karolinska University Hospital and Principal Investigator: “We are happy that the MPA has approved our application to, in collaboration with TIKOMED, use IBsolvMIR. Islet transplantation is a developing treatment for patients with severe forms of type 1 diabetes. It is established that initial graft loss is a major hurdle in these transplantations. IBsolvMIR may provide an opportunity to change that situation and improve patient outcomes.”

Olle Korsgren, M.D., Phd. Prof. in Cell transplantation, Uppsala University: “Since we discovered IBMIR we have known that it is key to improve the results in islet transplantation. IBsolvMIR is the drug we chose when we performed the CIT-01, a study sponsored by NIH. Our publication in TRANSPLANTATION shows IBsolvMIR’s positive effects, and we are very pleased to see that TIKOMED is now progressing with a follow-up study. With a positive effect in the islet field, we expect a similar positive effect on other transplanted cells and stem cells that could provide for increased efficacy and better outcomes for patients.”

Anders Svenson M.D., Chief Medical Officer of TIKOMED, commented, “Today, we present an important milestone, with the granted permission by the Swedish Medical Product Agency for our second phase 2a clinical trial with our investigational drug IBsolvMIR, and we look forward to start initiating the Islet cell transplantation clinical trial in the coming months at Karolinska and Uppsala University Hospital. We believe IBsolvMIR has significant potential for cell transplantation and we, therefore, look forward to the study outcome.”

Adam Bruce, Head of IBsolvMIR Program and Executive Board Member of TIKOMED, commented, “With IBsolvMIR we present a drug with great potential in the cell therapy field, it addresses a major hurdle and cost in the booming field of gene and cell therapy, namely graft loss. As the graft of therapeutic cells enters the bloodstream, it is instantly attacked, activating IBMIR that will destroy a large portion of the graft. IBsolvMIR saves the cells and helps them to engraft. We are committed to bringing IBsolvMIR through our Islet Cell transplantation clinical trial program and hopefully one step closer to patients. The clinical need is vast, not only in diabetes but also for patients suffering from chronic pancreatitis that could benefit from autologous transplantation and we hope IBsolvMIR will be a key ingredient to provide improved relief for patients.”





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