FDA has accepted Selvita’s IND application for the SEL24 Phase I/II clinical trial in AML

Kraków, Poland, 18 August 2016 – Selvita (WSE:SLV), the largest drug discovery company in Central and Eastern Europe, has received an acceptance for its IND application from the U.S. Food and Drug Administration (FDA) for SEL24, the first compound to advance in clinical development from the company’s internal discovery pipeline.

SEL24 is a novel, orally-available small molecule, the first potent, dual inhibitor of PIM and FLT3 kinases. It is the first molecule with this mechanism of action, to progress to such stage of development.

SEL24 shows therapeutic potential in the treatment of acute myeloid leukemia (AML), as well as other hematological malignancies such as non-Hodgkin’s lymphoma, Hodgkin’s lymphoma and multiple myeloma. Moreover, SEL24 increases the effectiveness of other anticancer agents in animal models.

Following this FDA clearance, Selvita will now seek for an opinion of the Institutional Review Boards at selected, leading clinical hospitals in US, which were chosen to conduct the SEL 24 Phase I/II clinical trial in AML patients, as well complete necessary formalities with the clinical sites.

Selvita intends to initiate first patient dosing in Q4 2016.