First patient treated in Europe
into the expansion cohort of Phase I/II DIAMOND-01 trial
POMEZIA, Italy, Sept. 16, 2020 /PRNewswire/ -- Menarini
Ricerche, the R&D division of the Menarini Group, announced
today that it has treated the first patient in Europe for the cohort expansion part of
DIAMOND-01 clinical trial (CLI24-001; NCT03008187) investigating
SEL24/MEN1703, a first-in-class, oral dual PIM/FLT3 inhibitor, as
the single agent in Acute Myeloid Leukemia (AML). The patient has
been dosed into the expansion cohort after the completion of the
dose escalation part of the trial, the results of which have been
presented at the most recent 25th Annual Meeting of the
European Hematology Association (EHA). The above cohort expansion
had already started in the US, with the first patient being treated
as of 21 July 2020.
DIAMOND-01 is a first-in-Human, Phase I/II dose escalation and
cohort expansion trial of SEL24/MEN1703 in AML – relapsed or
refractory as well as previously untreated patients unsuitable for
chemotherapy. The expansion cohort, which will be run in major
oncology centers both in the US and in Europe (Italy, Spain
and Poland) and will enroll
patients with relapsed or refractory AML, will further evaluate the
single agent activity and the safety profile of SEL24/MEN1703 at
the recommended dose as determined in the dose escalation part of
the study.
About Menarini
Menarini Ricerche is the Menarini Group's division dedicated to
R&D, with a strong commitment to oncology research and
development, as well as an active engagement in the infectious
disease area, being involved in the fight against the antimicrobial
resistance threat, a rising global concern.
As part of its commitment to oncology, Menarini's pipeline
includes five investigational new drugs for the treatment of a
variety of hematological and/or solid tumors: two biologics (the
monoclonal antibody anti-CD157 MEN1112/OBT357, and toxin-conjugated
anti-CD205 antibody MEN1309/OBT076), and three 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 acquisition of Stemline Therapeutics, a New York-based biopharmaceutical company,
strengthened Menarini's oncology portfolio with the addition of
both commercial and clinical-stage assets, including ELZONRIS® a
novel targeted therapy for the treatment of blastic plasmacytoid
dendritic cell neoplasm (BPDCN). Menarini has also entered into a
license agreement with Radius Health for the development and
commercialization of Elacestrant, an oral SERD in late stage Phase
3 development as hormonal treatment for breast cancer. Through the
work of Menarini Silicon Biosystems, Menarini is also developing
advanced technologies and products to study rare cells with
single-cell precision.
The Menarini Group is a leading international pharmaceutical and
diagnostics company, with turnover of €3.793 billion and over
17,000 employees. Menarini is focused on therapeutic areas with
high unmet needs with products for cardiology, gastroenterology,
pneumology, infectious diseases, diabetology, inflammation, and
analgesia. With 16 production sites and 10 Research and Development
centers, Menarini's products are available in 140 countries
worldwide. For further information please visit
www.menarini.com
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