美国食品和药物管理局批准Pentixapharm®的新型白血病和骨髓瘤治疗试验, FDA approves Pentixapharm’s trial for new leukemia and myeloma treatment using targeted imaging and radiotherapy.

Pentixapharm已获得FDA“研究可继续”两项IND申请批准，使其CXCR4靶向治疗性疗法在急性髓系白血病和多发性骨髓瘤中得以进行I/II期临床试验。 Pentixapharm has received FDA "Study May Proceed" approval for two IND applications, enabling a Phase I/II trial of its CXCR4-targeted theranostic approach in acute myeloid leukemia and multiple myeloma. 试验将测试Pentixfor成像和[90Y]Y-PentixaTher定向放射治疗,作为干细胞移植前常规骨髓调节的毒性较低的替代品。 The trial will test PentixaFor for imaging and [⁹⁰Y]Y-PentixaTher for targeted radiotherapy as a less toxic alternative to conventional bone marrow conditioning before stem cell transplantation. 林业发展局的30天审查证实了这项研究的安全性,标志着一个重要的监管里程碑。 The FDA’s 30-day review confirmed the study’s safety, marking a key regulatory milestone. 该公司计划根据战略优先事项和资源供应情况确定试行时间。 The company plans to determine trial timing based on strategic priorities and resource availability.