FDA completes 30-day safety review of two IND applications for CXCR4-targeted theranostic program in hemato-oncology; proposed clinical study may proceed
“The U.S. INDs provide important regulatory validation of our CXCR4-targeted approach and support its advancement in the stem cell transplant setting, combining PentixaFor imaging with [⁹⁰Y]Y-PentixaTher,” said Dirk Pleimes, CEO of Pentixapharm. “AML and MM are significant hematologic malignancies where transplantation remains central to treatment. We believe that targeted bone marrow conditioning has the potential to offer a differentiated strategy within this established chemotherapy-based paradigm. This regulatory milestone also builds on our ongoing investigator-initiated clinical studies in AML in Europe.”
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