AUSTIN, Texas, Nov. 03, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to rhenium (186Re) obisbemeda for the treatment of breast cancer with leptomeningeal metastases (LM).

2023年11月3日（GLOBE NEWSWIRE）-Plus Therapeutics，Inc.（纳斯达克股票代码：PSTV）（“公司”），一家临床阶段制药公司，为中枢神经系统癌症开发具有先进平台技术的靶向放射治疗，今天宣布，美国食品和药物管理局（FDA）已授予rhenium（186Re）obisbemeda孤儿药名称（ODD），用于治疗软脑膜转移瘤（LM）的乳腺癌。

ODD status is granted by the FDA to an investigational drug or biological product intended to prevent, diagnose or treat a rare diseases or condition affecting fewer than 200,000 people in the United States. Companies granted ODD are eligible for certain benefits, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and 7 years of post-approval marketing exclusivity.

FDA对旨在预防，诊断或治疗影响美国不到20万人的罕见疾病或病症的研究药物或生物制品给予ODD状态。授予ODD的公司有资格获得某些福利，包括药物开发过程中的帮助，临床费用的税收抵免，某些FDA费用的免除以及7年的批准后营销专有权。

“Receiving Orphan Drug Designation from the FDA is important validation of our radiotherapeutic candidate for breast cancer patients with LM who currently have no FDA-approved treatment options,” said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. “LM is a rapidly progressing and fatal complication of several cancers, including breast cancer, and incidence continues to rise.

Plus Therapeutics公司总裁兼首席执行官Marc H.Hedrick博士说：“从FDA获得孤儿药指定是我们目前没有FDA批准治疗方案的LM乳腺癌患者放射治疗候选者的重要验证。”。“LM是包括乳腺癌在内的几种癌症的快速进展和致命并发症，发病率持续上升。

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 continued progress of our ReSPECT-LM program.” Rhenium (186Re) obisbemeda is currently being evaluated in the ReSPECT-LM Phase 1/2a dose escalation clinical trial.

ODD状态以及之前授予的快速通道指定强调了LM新治疗方案的重大和迫切需求。我们相信rhenium（186Re）obisbemeda有可能解决这一未满足的需求，我们期待着ReSPECT LM计划的持续发展。”Rhenium（186Re）obisbemeda目前正在ReSPECT LM 1/2a期剂量递增临床试验中进行评估。

Cohort 4 of the ReSPECT-LM trial recently completed enrollment,.

ReSPECT LM试验的第4组最近完成了登记，。