Core Viewpoint - Plus Therapeutics has received Orphan Drug Designation from the FDA for Rhenium (186Re) Obisbemeda, aimed at treating leptomeningeal metastases in lung cancer patients, highlighting the urgent need for new therapies in this underserved area [1][2]. Company Overview - Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for central nervous system cancers, with a pipeline that includes treatments for recurrent glioblastoma and leptomeningeal metastases [6][7]. - The company utilizes advanced platform technologies that combine image-guided local beta radiation and targeted drug delivery approaches to enhance clinical outcomes for patients [6]. Product Development - Rhenium (186Re) Obisbemeda is a novel injectable radiotherapy designed to deliver targeted high-dose radiation to CNS tumors, potentially improving patient outcomes compared to existing therapies [5]. - The company has completed the ReSPECT-LM Phase 1 single-dose trial, establishing the recommended Phase 2 dose, and is advancing into further clinical trials [3]. Market Context - Leptomeningeal metastases (LM) is a rare but serious complication of cancer, affecting approximately 5% of cancer patients, with a particularly high incidence in lung cancer and breast cancer [4]. - There are currently no FDA-approved therapies specifically for LM patients, emphasizing the critical need for innovative treatments in this area [4]. Regulatory Milestones - The Orphan Drug Designation provides several benefits, including seven years of market exclusivity, tax credits for clinical trials, and exemptions from significant regulatory fees, which can facilitate the development and commercialization of Rhenium (186Re) Obisbemeda [2].
Plus Therapeutics Granted U.S. FDA Orphan Drug Designation for Rhenium (186Re) Obisbemeda for the Treatment of Leptomeningeal Metastases in Patients with Lung Cancer