juni 30, 2022

Ectin Research AB begins process of initiating trial site in Sweden for its combined Phase I/II study

Ectin Research previously announced that the Phase I part of the combined Phase I/II clinical trial of MFA-370 for the treatment of metastatic urothelial bladder cancer was planned to be initiated at trial site in Q2 2022. Ectin now announces that all regulatory approvals have been obtained in Sweden for the clinical trial and that two trial sites for the Company’s Phase I/II clinical trial have been contracted in Sweden and one in Denmark, that site-initiation visits (SIV) are planned in Sweden and after SIV completion, patient enrollment will take place. The company further announces that the site initiation process in Sweden has started in June and will be completed after the summer.

The Company now announces that all regulatory approvals to initiate the Company’s combined Phase I/II clinical trial in Sweden have been obtained, as the amendment has previously been approved by both the MPA as well as the Ethical review authority and now the biobank application has also been approved. Two trial sites, Ryhov County Hospital in Jönköping and Karolinska Hospital in Stockholm, have been contracted to participate in the study and site-initiation visits at the trial site are planned with patient recruitment taking place after completion. The company also announces that the trial site initiation process has started in June as planned and will be completed after the summer. In parallel with the pre-clinical activities in Sweden, the company is also engaged in obtaining regulatory approvals for trial sites in Lithuania, Germany and Denmark where all regulatory applications have now been submitted. A trial site in Denmark, Aalborg University Hospital, has also been contracted for the company’s Phase I/II clinical study. The aim of the applications is to open additional sites and start patient recruitment for the Phase I part of the Phase I/II study in additional countries.