As the founding investor we are proud to see iOnctura graduate to Phase II clinical development. OCULE-01, a randomized Phase II will study roginolisib as a monotherapy in metastatic uveal melanoma (UM), one of many Phase IIs in progress. Roginolisib, the only precise inhibitor of PI3Kδ, in the completed Phase I study, has shown stellar safety and a doubling of overall survival in metastatic uveal melanoma patients compared to historical controls. Very exciting time for the company that we hope will progress to a highly needed treatment for patients.
Today we are pleased to announce we have dosed our first patient in randomized Phase II study, OCULE-01. OCULE-01 is investigating our allosteric modulator of #PI3Kδ, #roginolisib, in uveal melanoma, a rare cancer of the eye. Allosteric modulation is a new archetype for precise inhibition of PI3Kδ, promising clinical activity without the detrimental tolerability seen with previous generations of inhibitors. In Phase I, roginolisib demonstrated an excellent safety profile and a doubling of overall survival in metastatic uveal melanoma patients compared to historical controls. 👉 Read the press release here: https://lnkd.in/ekMMhJnS 👉Details of the OCULE-01 study: https://lnkd.in/ezQFQVYr
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1wCongrats Hakan!