januari 11, 2022

Ectin Research AB receives approval from Swedish Ethical Review Authority for its phase I/II study of MFA-370

Ectin Research has previously announced that the Swedish Medical Products Agency has approved the Company’s application to conduct a clinical phase I/II study of MFA-370 for the treatment of patients with metastatic urothelial bladder cancer. In Nov 2021, the ethics application for the implementation of the study was sent to the Ethical Review Authority, who have now approved the application. The study will now be initiated according to plan with the first dose planned to take place during Q1 2022.

Current treatments for metastatic urothelial bladder cancer require recurring and long hospital stays and have a limited clinical treatment effect. 5-year survival in the patient group is only 5%. Established treatment also often causes severe side effects that can significantly reduce the patient’s quality of life.

Ectin Research’s innovative cancer treatment MFA-370 is taken orally and is a combination of two well-established drugs with few and tolerable potential side effects. Ectin Research has now been granted an ethical permit by the Ethical Review Authority for MFA-370 in Sweden for its phase I/II study of patients with metastatic urothelial bladder cancer. The first part, the phase I study, is primarily intended to examine safety and tolerability and also to determine the recommended phase II dose. Phase I comprises 24 weeks of treatment with MFA-370 in approximately 10 patients in Sweden. If the results of the phase I study show that the treatment has an acceptable side effect profile, phase II will be initiated. In order to maintain a satisfactory recruitment rate of patients during the course of the study, Ectin Research plans in Q1 2022 to submit additional clinical trial applications in two other European countries together with the contract research organization LINK Medical Research AB. The clinical phase I/II study is planned to be initiated during Q1 2022, where the first patient is planned to be dosed in Q1 2022 and the study is expected to last until H2 2024. Thereafter, the patients will be followed for another 6 months to follow up the treatment results.

Ectin Research’s CEO Anna Sjöblom-Hallén: ”We are extremely pleased with the project’s development and the Ethical Review Authority’s decision, which means that we can now follow our plan for clinical development of MFA-370, a safer and more effective treatment of metastatic urothelial bladder cancer.”