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2021-07-14

Ectin Research AB meddelar att ansökan om klinisk läkemedelsprövning är inlämnad till Läkemedelsverket.

Ectin Research har lämnat in en ansökan till Läkemedelsverket om klinisk läkemedelsprövning (CTA) i en fas I/II studie med MFA-370. Studien ämnar dels utvärdera MFA-370 ur säkerhet och tolerabilitets hänseende såväl som säkerställa huruvida klinisk behandlingseffekt uppnås i patienter med metastaserad urotelial blåscancer. Ectin Research ämnar senare skicka in ytterligare kliniska prövningsansökningar i två andra europeiska länder.

Bolaget planerar initiera fas I delen av den planerade kliniska fas I/II studien under slutet av 2021. Fas I delen utgör en studie av cirka 10 patienter med metastaserad urotelial blåscancer i Sverige där fokus är att studera MFA-370 ur säkerhets och tolerabilitets synvinkel samt fastställa rekommenderad fas II dos. Förutsatt att Läkemedelsverket sedan godkänner resultatet av fas I delen planerar bolaget därefter, förutsatt nödvändigt kapital är säkerställt, inleda fas II delen i Sverige och två andra länder i Europa, av ytterligare cirka 30 patienter för att statistiskt utvärdera MFA-370 kliniska behandlingseffekt på patienter med metastaserad urotelial blåscancer. Huvudprövare är professor Anders Ullén, och sponsor Ectin Research. Studien genomförs i samarbete med Karolinska Universitetssjukhuset i Solna.  

VD Anna Sjöblom-Hallén kommenterar

 ”I och med den kliniska prövningsansökan har Ectin Research tagit ett mycket betydande utvecklingssteg framåt i att närma oss en klinisk prövning av MFA-370. Tillsammans med våra erfarna samarbetspartners kontraktforskningsorganisationen LINK Medical Research och professor Anders Ullén har vi ett fantastiskt studieteam för den fortsatta utvecklingen av en tryggare och förhoppningsvis effektivare behandling av patienter med metastaserad urotelial blåscancer.”

Ectin meddelar inlämnar klinisk läkemedelsprövning till Läkemedelsverket.

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Contact

AstraZeneca BioVentureHub
Pepparedsleden 1
SE-431 83 Mölndal
Sweden

About Ectin Research AB

Ectin Research AB pharmaceutical company is developing a novel treatment that aims to eliminate cancer tumors. Its drug candidate MFA-370 will first be trialled for the treatment of metastatic urothelial bladder cancer. MFA-370 consists of two existing drugs that have already undergone large-scale clinical trials and are currently widely used in other indications. In preclinical studies MFA-370 has achieved successful results for the treatment of metastatic urothelial bladder cancer, and has also shown promising potential in other cancers such as breast, colorectal and prostate cancer cells.

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