Pentixapharm Advances CXCR4-Based Hemato-Oncology Program with FDA Approval

Pentixapharm Holding AG announced that the FDA has approved their two Investigational New Drug (IND) applications for a CXCR4-targeted program in hemato-oncology. This approval follows a thorough 30-day review process by the FDA. The applications are for the radiotheranostic pair PentixaFor and PentixaTher, aimed at advancing bone marrow conditioning methods.

The proposed phase I/II trial will explore the use of CXCR4-directed radiotherapy in preparing bone marrow for stem cell transplants in patients with acute myeloid leukemia (AML) and multiple myeloma (MM). The study's goal is to provide an alternative to conventional chemotherapy, which often carries significant toxicity.

This regulatory milestone supports Pentixapharm's innovative approach of combining targeted imaging with precise conditioning, potentially reshaping treatment paradigms for AML and MM, which require stem cell transplantation as a critical intervention.