Menarini receives FDA orphan drug designation for acute myeloid leukemia drug

Florence, Italy, November 5, 2021/PRNewswire/ - Menarini Group today announced that the U.

ODD is awarded by the FDA to therapies designed to treat diseases that affect less than 200,000 people in the United States, and provides companies with multiple incentives to support the development of treatment and diagnosis of rare diseases

Elcin Barker Ergun, Chief Executive Officer of Menarini Group, said: "The FDA orphan drug qualification is an important milestone in the SEL24/MEN1703 program

DIAMOND-01 (CLI24-001; clinicaltrials.

In the dose upgrade part of the DIAMOND-01 trial, SEL24/MEN1703 demonstrated the controllable safety of the maximum recommended dose (RD) of 125 mg/day and preliminary evidence of anti-leukemia activity as a single agent

This trial is currently recruiting AML patients with IDH1 or IDH2 mutations to further study the viability of SEL24/MEN1703 in this molecularly determined subgroup of patients

About SEL24/MEN1703 

SEL24/MEN1703 is a first-of-its-kind oral dual PIM/FLT3 inhibitor, which is licensed internally by Menarini from Ryvu Therapeutics

About Menarini's Oncology Work 

At Menarini, we recognize that patients’ hopes for longer and healthier lives are inseparably connected with the progress of scientific and medical research-this is the driving force behind our progress

Menarini Group has a firm commitment to oncology research and development, while focusing on treatment and diagnosis

The 2020 acquisition of Stemline Therapeutics, a New York biopharmaceutical company, marks Menarini Group’s entry into the US biopharmaceutical oncology market.

For more information about the Menarini project, please visit a dedicated page on our website: https:// Menarini 

Menarini Group is a leading international pharmaceutical and diagnostic company with more than 17,000 employees and a turnover of 4.