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2021-12-22

Ectin Research AB lämnar uppdatering inför start av den kombinerade fas I/II-studien

Ectin Research AB (”Ectin” eller ”Bolaget) meddelar att Bolaget har skickat in etikansökan som krävs för att initiera den kliniska fas I/II-studien. Vid  godkännande av den etiska ansökan beräknas fas I-delen initieras och patienter kunna börja rekryteras under Q1 2022, och förutsatt att patientrekryteringen går som planerat avslutas fas I-delen under Q4 2022. Slutligen kan Bolaget meddela att ett avtal slutits med Tamro AB för leverans av studieläkemedel till den kliniska studien. 

Den 1 september 2021 meddelade Ectin att Bolaget hade fått godkännande av Läkemedelsverket för att genomföra en klinisk fas I/II-studie av MFA-370 för behandling av patienter med metastaserad urotelial blåscancer. Studiens första del (fas I) omfattar 24 veckors behandling av 10 patienter med MFA-370 där utvärdering av säkerhet och tolerabilitet sker efter 6 veckors behandling. Om resultatet från fas I-studien visar att behandlingen har en acceptabel biverkningsprofil, kommer fas II-delen av studien att initieras förutsatt att finansiering är anskaffad.

Ectin har skickat in den etikansökan som krävs för att kunna initiera den kliniska fas I/II-studien. Förutsatt ett godkännande av den etiska ansökan avser Bolaget att starta fas I-delen av den kombinerade fas I/II-studien i första kvartalet 2022 och förutsatt att patientrekryteringen går som planerat avsluta fas I-delen under det fjärde kvartalet 2022.

Bolaget meddelar även att avtal slutits med Tamro AB för att hantera logistiken kring studieläkemedel till studien. Logistiktjänster har varit Tamros kärnverksamhet i 100 år.

Ectin Research VD, Anna Sjöblom-Hallén: ”Vi är oerhört nöjda med att slutit ett avtal för hantering av studieläkemedel till vår kliniska fas I/II-studie. Tamro har ett gediget rykte i branschen för en trygg och säker distribution av läkemedel till hälso- och sjukvården.”

Ectin Research klinikuppdatering

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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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