FDA lifts partial block on clinical trial of RVU120

The US Food and Drug Administration has lifted a partial clinical hold, previously announced on April 8, 2021, on the first-in-human (FIH) Phase Ib, dose escalation clinical trial of RVU120 (also known as SEL120) in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (high-risk MDS), being conducted in the USA, Poland largest biotech Ryvu Therapeutics (WSE: RVU) announced today.

As a result of the development, Ryvu’s shares closed today’s trading up 1.3% at 63.80 zloty, having hit a high of 68.80 zloty (+7%) in earlier activity.

“We believe that the initially demonstrated benefit of treatment with RVU120 as a single agent for AML and MDS patients, coupled with the amended study protocol will lead to a safe, timely and successful completion of the clinical trial. We will be working closely with the investigators and the clinical sites to obtain IRBs’ approvals on the revised protocol and resume patient enrolment in Q3 2021,” said Pawel Przewiezlikowski, chief execu Publishtive of Ryvu Therapeutics.