POMEZIA, Italy, May 14, 2020 /PRNewswire/ -- Menarini Ricerche announces the completion of the dose escalation part of the First in Human, phase I/II DIAMOND trial (CLI24-001; NCT03008187) currently ongoing to evaluate SEL24/MEN1703, a first in class, oral dual PIM/FLT3 inhibitor in development for the treatment of acute myeloid leukemia (AML). The results will be disclosed at the 25th EHA virtual meeting with the e-poster entitled "Results of the dose escalation part of DIAMOND trial (CLI24-001): first in human study of SEL24/MEN1703, a dual PIM/FLT3 kinase inhibitor, in patients with acute myeloid leukemia" (EP604).
The primary objectives of the dose escalation part of the study were the identification of dose limiting toxicities, the determination of the maximum tolerated dose and recommended dose for the phase 2 part of the study, as well as characterization of the pharmacokinetics of SEL24/MEN1703 in AML – relapsed or refractory as well previously untreated - patients unsuitable for chemotherapy. Throughout the dose escalation part, SEL24/MEN1703 showed an acceptable safety profile up to the recommended dose established at 125 mg/day (14 days ON – 7 days OFF in 21-days cycles). Initial evidence of single agent efficacy was observed with 1 CR and 1 CRi in elderly patients who had exhausted standard therapeutic options. Cohort Expansion study in relapsed/refractory AML patients will further investigate the single agent activity and the safety profile of SEL24/MEN1703.
"The promising results from the dose-escalation phase of the DIAMOND trial provide a strong rationale to progress to the cohort expansion phase of the study," said Dirk Laurent, Global Therapeutic Area Head - Oncology of Menarini Ricerche. "We look forward to further revealing the potential of the SEL24/MEN1703 program to the benefit of AML patients who need innovative and effective therapeutic options."
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 pipeline includes five investigational new drugs for the treatment of a variety of hematological and/or solid tumors. 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. 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 present 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, Menarini's products are available in 136 countries worldwide.