Oryzon Genomics has announced that the European Medicines Agency (EMA) has provided regulatory clearance to launch a Phase II study of iadademstat, the company’s lead clinical candidate in oncology and haematology, in patients with essential thrombocythemia (ET). ET is a rare form of myeloproliferative neoplasm, a type of chronic blood cancer. Many patients face resistance or intolerance issues with current treatment options, creating a significant unmet medical need. Oryzon’s clinical trial, termed IDEAL, will be a multicentre, single-arm study, based in Spain, in adult patients with ET who are resistant or intolerant to hydroxyurea. Primary outcome measures will be safety and tolerability, with secondary outcome measures focused on testing durable clinical hematologic response rates, pharmacokinetic and pharmacodynamics, and evaluating the duration of hematologic remissions.
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