FDA lifts Clinical Hold on Selvita’s Phase I/II Clinical Trial with SEL24 in AML

Krakow, Poland – December 16, 2017 – Selvita S.A. (WSE:SLV), a clinical stage drug discovery and development company focused on innovative medicines for patients with blood cancers, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold, previously announced on October 7, 2017, on Phase I/II clinical trial of SEL24 in patients with relapsed/refractory (R/R) AML.

Together with our global development partner Menarini Group, we agreed with the FDA conclusions on the data gathered so far in our Phase I/II trial to evaluate SEL24 in acute myeloid leukemia, and agreed to continue the study with additional provisions to the study protocol. We will be working closely with the investigators and clinical sites to obtain IRB’s approval on the revised protocols and resume patient enrollment – said Krzysztof Brzozka, Ph.D., Chief Scientific Officer of Selvita.
We hope that the swift resumption of studies will bring us closer to delivering a much-needed new treatment for AML patients.

Selvita agreed with the FDA to revise the dose-finding scheme to a standard 3+3 design under an amended protocol based on the recommendations of the FDA.

The current open-label, single-agent, dose escalation Phase 1 study of SEL24 was initiated in the first quarter of 2017 in patients with relapsed and refractory acute myeloid leukemia. The study is designed to determine the maximum tolerated dose (MTD) and recommended dose of SEL24.


About Selvita
Selvita is a drug discovery company, developing breakthrough therapies in the area of oncology. The company’s most advanced program, SEL24, has been licensed to Menarini Group and is currently in Phase I studies in AML. Other projects include SEL120, a first-in-class small molecule inhibitor of CDK8 in preclinical studies, several drug discovery platforms in immuno-oncology, immunometabolism and cancer metabolism, as well as epigenetics, performed independently or in collaboration with global pharma and biotech companies.
Selvita also offers a broad range of integrated drug discovery services, helping biotech and pharma partners discover and develop new drugs.
The company has alliances and partnerships with more than fifty large and medium-sized pharmaceutical and biotechnology companies from USA and Europe, including R&D partnerships with Menarini Group, Leukemia and Lymphoma Society, Merck, H3 Biomedicine, and Nodthera.
The company was established in 2007 and currently employs over 440 scientists, among which 30% are PhDs. Selvita is headquartered in Krakow with second research site in Poznan, Poland and international offices located in Cambridge, MA and San Francisco Bay Area, in the US, as well as in Cambridge, UK. Selvita is listed on the Warsaw Stock Exchange (WSE:SLV). More information: https://selvita.com/

About SEL24
SEL24 is a Selvita-developed first-in-class dual PIM/FLT3 kinase inhibitor with a unique activity profile in oral formulation. It is intended for the treatment of patients with relapsed/refractory (R/R) AML. The major goal for treatment of R/R AML is to achieve remission or to significantly prolong life, with acceptable quality. In March 2017, the first patient was dosed with SEL24 in a Phase I/II clinical trial. On March 28, 2017, Selvita S.A. and Menarini Group, entered into a global license agreement for SEL24. Selvita remains the sponsor of the study during the transition period to Menarini Group.