Pomezia, Italy, December 9th, 2019 – Menarini Ricerche is progressing with the clinical development of SEL24/MEN1703, and will be presenting the design of the ongoing First In Human clinical trial DIAMOND-01 (NCT03008187) at the 61st ASH Congress, with a poster entitled: “First in Human Study of SEL24/MEN1703, First in Class, Orally Available Dual PIM/FLT3 Kinase Inhibitor, in Patients with Acute Myeloid Leukemia”. The poster, which will be disclosed today during the “Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation” session, describes the ongoing adjustment to the dose escalation design, with the objective to obtain more robust data on the recommended phase 2 dose.
CLI24-001 (DIAMOND-01) trial is testing SEL24/MEN1703, a first in class, oral dual PIM/FLT3 inhibitor in-licensed from Ryvu Therapeutics. The primary objective of the study, currently carried out in newly diagnosed, relapsed or refractory AML (excluding acute promyelocytic leukemia) patients who are unsuitable for intensive chemotherapy, is to identify the recommended phase 2 dose of SEL24/MEN1703 given as single agent.
Furthermore, a second abstract reporting the identification of a pharmacodynamic biomarker for SEL24/MEN1703 and its implementation in the DIAMOND-01 trial, has been disclosed by ASH as e-publication and is available in a special online-only issue of ASH's official Journal -Blood (2019) 134 (Supplement 1): 5087-.
Menarini strongly believes in innovation and is investing in the research and development of new treatment options for oncology patients, focusing on targeted therapies and precision medicine approaches. The contribution of Menarini Ricerche to ASH with these data confirms such commitment to the development of innovative drugs that meet the needs of patients with difficult to treat cancers and poor prognosis.
