The Management Board of Ryvu Therapeutics S.A. with its seat in Krakow (formerly operating under the name: Selvita SA, hereinafter referred to as the "Issuer") informs that on September 15, 2020 it received from Menarini Ricerche SpA belonging to the Italian group Menarini ("Menarini"), which is the sole sponsor of the SEL24 / clinical trial MEN1703 (in accordance with the license agreement concluded by the Issuer, about which the Issuer informed RB No. 4/2017), information on the administration of SEL24 / MEN1703 to the first patient in a European clinical center, as part of the ongoing phase II clinical trial DIAMOND-01 conducted in patients with acute leukemia the marrow.
According to the information obtained from Menarini, the patient was dosed as part of the commencement of the cohort expansion stage, after completing the dose escalation stage, the results of which were presented in June by Menarini at the 25th Annual Meeting of the European Hematology Association conference (EHA), about which the Issuer informed in RB No. 11/2020.
DIAMOND-01 (CLI24-001; NCT03008187) is a Phase I / II phase I / II clinical trial of dose escalation and cohort expansion, conducted in patients with relapsed or refractory acute myeloid leukemia, as well as in previously untreated people who are not eligible for chemotherapy. The aim of the cohort expansion phase is to further evaluate the activity and safety profile of SEL24 / MEN1703 as monotherapy at the recommended dose determined at the dose escalation stage.
According to the information obtained from Menarini, the cohort's expansion stage will be carried out in leading cancer centers in the United States and Europe, incl. in clinical centers in Italy, Spain and Poland.
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