Plus Therapeutics Receives FDA ODD For Rhenium (186Re) Obisbemeda

(RTTNews) - Plus Therapeutics, Inc. (PSTV) announced on Friday that the FDA has granted Orphan Drug Designation (ODD) to rhenium (186Re) obisbemeda for the treatment of breast cancer with leptomeningeal metastases (LM).

Rhenium (186Re) obisbemeda is an innovative injectable radiotherapy that has been specifically formulated to administer highly targeted high-dose radiation in the treatment of central nervous system (CNS) tumors.

This therapy is designed to optimize patient outcomes safely, effectively, and conveniently. Rhenium (186Re) obisbemeda has the potential to reduce risks and improve outcomes for CNS cancer patients in comparison to presently approved therapies, as it delivers a more targeted and potent radiation dose.

Currently, the ReSPECT-LM Phase 1/2a dose escalation clinical trial is evaluating rhenium (186Re) obisbemeda. Cohort 4 of the trial has completed enrollment, and a standard safety review is expected to be followed by the move into Cohort 5.

Marc H. Hedrick M.D., President and CEO of Plus Therapeutics said, "LM is a rapidly progressing and fatal complication of several cancers, including breast cancer, and incidence continues to rise. ODD status, together with the previously granted Fast Track designation, underscores the significant and urgent need for new treatment options for LM. We believe rhenium (186Re) obisbemeda has the potential to address this unmet need, and we look forward to the continued progress of our ReSPECT-LM program."