FDA lifts clinical hold on Selvita's Phase I/II clinical trial with SEL24 in AML

Polish biotech firm Selvita (WSE: SLV) says that the US Food and Drug Administration 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) acute myeloid leukemia (AML).

The FDA’s decision to issue the clinical hold followed a Suspected Serious Unexpected Adverse Reaction Report that a fatal stroke in Patient in Cohort 5 receiving the 150mg dose of SEL24 had been evaluated by investigators as possibly related to the study treatment.

“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, chief scientific officer of Selvita,” adding: “We hope that the swift resumption of studies will bring us closer to delivering a much-needed new treatment for AML patients.