The FDA will allow Selvita to conduct a Phase 1 study on an Investigational New Drug for acute myeloid leukemia or high-risk myelodysplastic syndrome.
The two goals of the study will be to evaluate SEL120 for safety and tolerability and to establish the recommended dosage for further studies. This study will be for refractory patients or patients who have relapsed after other therapy. SEL120 inhibits the enzyme CDK8.
“In preclinical studies, including studies with patient-derived xenografts, SEL120 has demonstrated strong promise using a novel and differentiated approach to treatment in AML,” said Steffen Heeger, chief medical officer of Selvita. “This dose-finding study will help provide data in patients to potentially support the high selectivity of SEL120 for its target, a property that suggests potential for either stand alone or combination treatments. We expect to initiate dosing of the first patient with SEL120 in the third quarter of 2019. In addition, because of the recognized importance of CDK8 as a therapeutic target, we are optimistic about the potential for SEL120 to be evaluated in multiple indications beyond AML as the properties of this candidate in clinical settings become clear.”
Selvita is headquartered in Krakow, Poland. It develops novel small molecule therapies to address emerging targets in oncology.
