ROME, Dec. 9, 2019 /PRNewswire/ -- 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.
Menarini Group is an Italian pharmaceutical company with a turnover of 3.667 billion Euro and more than 17,000 employees. The Menarini Group has always pursued two strategic objectives: research and internationalization, and has a strong commitment to oncology research and development. As part of such commitment to oncology, Menarini is developing five investigational new oncological drugs. Two of them are biologics, one is the monoclonal antibody anti-CD157 MEN1112/OBT357, and the other is a toxin-conjugated, anti-CD205 antibody MEN1309/OBT076. Other three are small molecules: the dual PIM and FLT3 kinase inhibitor SEL24/MEN1703, the PI3K inhibitor MEN1611 and the inhibitor of class I, II, and IV histone deacetylase, Pracinostat. All the drugs are currently in clinical development for the treatment of a variety of hematological and/or solid tumors. The Menarini Group's commitment to precision oncology is also supported by Menarini Silicon Biosystems' technologies and products to study rare cells with single-cell precision.
Menarini is active commercially in the most important therapeutic areas with products for cardiology, gastroenterology, pneumology, infectious diseases, diabetology, inflammation, and analgesia. With 16 production sites and 7 Research and Development centers, the Menarini Group has a strong presence throughout Europe and Asia, Africa, Central and South America. Menarini's products are available in 136 countries worldwide.