REYOBIQ™ Advances In Clinical Development With New Multi-Dose CNS Cancer Trial Aligned With FDA Guidelines

Plus Therapeutics has commenced patient dosing in its ReSPECT-LM trial for REYOBIQ™ (rhenium Re186 obisbemeda), a radiotherapeutic being developed to treat leptomeningeal metastases (LM), a complication of central nervous system cancers. The company previously completed a Phase 1 single-dose escalation study that confirmed the treatment's feasibility.

“Based on the promising, recently completed Phase 1 single-dose escalation study and lack of FDA approved therapies for LM, we expect trial enrollment to proceed rapidly in accordance with the trial protocol,” said Andrew Brenner, M.D., Ph.D., Professor-Research, Departments of Medicine, Neurology, and Neurosurgery & S & B Kolitz/CTRC-Zachry Endowed Chair Neuro-Oncology Research, Mays Cancer Center at UT Health San Antonio. “Furthermore, assuming REYOBIQ continues its attractive safety profile, we expect that we will enroll all required patients and doses in Cohort 1 by the end of this year.”

The new trial aims to determine the most effective and safest dosing strategy for REYOBIQ by delivering multiple doses through an intraventricular catheter. It is designed in accordance with the U.S. FDA’s Project Optimus framework, which encourages more rigorous optimization of dose regimens in oncology drug development.

Key goals of the study include evaluating safety, tolerability, and identifying both the maximum tolerated and minimum effective doses. The trial will include patients with LM originating from any type of solid tumor, positioning REYOBIQ as a potential breakthrough in treating a hard-to-reach and currently under-addressed cancer complication.