Investing News NetworkJuly 22, 2024Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, is pleased to announce that it has received clearance for its Investigational New Drug (IND) application with the US Food and Drug Administration (FDA), for F18-Pivalate (RAD 101).

投资新闻网2024年7月22日Radiopharm Theranostics（ASX:RAD，“Radiopharm”或“公司”）是一家临床阶段的生物制药公司，专注于为高度未满足的医疗需求领域开发创新的肿瘤放射性药物，很高兴地宣布，它已获得美国食品和药物管理局（FDA）批准其F18新戊酸（RAD 101）的研究性新药（IND）申请。

Pivalate, labelled with the radioisotope F18, is a small molecule that selectively targets fatty acid synthetase, which is overexpressed in brain tumours but not in normal cells. Pivalate is a novel proprietary imaging agent under clinical investigation for the detection and characterisation of brain metastases.The IND approval is a clear recognition by the FDA of clinical data already generated for RAD 101 and is a significant milestone towards starting a Phase 2b multi-center trial for the imaging of brain metastases.

用放射性同位素F18标记的新戊酸是一种选择性靶向脂肪酸合成酶的小分子，脂肪酸合成酶在脑肿瘤中过表达，但在正常细胞中不表达。丙戊酸钠是一种正在临床研究中的新型专有显像剂，用于检测和表征脑转移瘤。IND的批准是FDA对RAD 101已经产生的临床数据的明确认可，也是启动脑转移瘤成像2b期多中心试验的重要里程碑。

Radiopharm anticipates having the first patient dosed during the fourth quarter of 2024. Based on current enrolment expectations, the 30-patient Phase 2b read-out is expected by mid-2025 and will be followed by a Phase 3 registrational study.Previously reported positive data from the Imperial College of London’s Phase 2a imaging trial of Pivalate in 17 patients with brain metastases showed significant tumour uptake that was consistent with and independent from the tumour of origin¹.

Radiopharm预计将在2024年第四季度给第一名患者服用药物。根据目前的入学预期，预计到2025年年中将进行30名患者的2b期阅读，随后将进行3期注册研究。先前报道的伦敦帝国理工学院（Imperial College of London）对17例脑转移患者进行的丙戊酸2a期成像试验的阳性数据显示，显着的肿瘤摄取与起源肿瘤¹一致且独立。

This supports the potential use of pivalate to monitor brain metastases.“Pivalate represents a potential new target for radiopharmaceutical brain imaging agents, and its unique mechanism of action may offer eligible patients and the medical community an alternative to overcome the limitations of current standard of care for imaging brain metastasis.” said Ri.

这支持了丙戊酸钠监测脑转移的潜在用途。“丙戊酸盐代表了放射性药物脑显像剂的潜在新靶点，其独特的作用机制可能为符合条件的患者和医学界提供替代方案，以克服目前脑转移成像标准的局限性。”Ri说。