NEWS / FEBRUARY 10, 2021
PENTIXAPHARM receives confirmation from EMA that its Lead Candidate PENTIXAFOR is ready for Phase III Study
EMA verifies that there is sufficient safety data available.
Würzburg (Germany), February 10th, 2021 – PentixaPharm, a radiopharmaceutical development company, received confirmation from the European Medicines Agency (EMA) last week that its lead candidate PentixaFor may be advanced directly in a phase III development program. The positive assessment of the authority was given in an Initial Scientific Advice Meeting, which addressed non-clinical, clinical, and CMC aspects. EMA followed the reasoning of PentixaPharm that there is sufficient safety data available to initiate a phase III program for the [68Ga]Gallium based PET agent and responded positively to the proposed development design. PentixaPharm will now start the operational preparations for a Phase III Study, including a follow-up Scientific Advice with EMA. In addition, PentixaPharm will begin its Series B fundraising process.
“We are delighted that EMA shared our view that PentixaFor is ready for a Phase III study and opens the possibility to develop the lead compound PentixaFor effectively to the next level. With the Initial Scientific Advice, we have a good understanding which non-clinical, clinical and CMC subjects have to be addressed”, says Dr. Hakim Bouterfa, Managing Director of PentixaPharm.
“The regulatory feedback is an important milestone for our clinical as well as our CMC development strategy and accelerates our commitment to make our PET tracer PentixaFor widely available to patients across Europe in a state of the art ready to use kit-design”, adds Dr. Jens Kaufmann, Managing Director of PentixaPharm.”
PentixaFor specifically targets the CXCR4-CXCR12 axis, which is significantly involved in the interaction and proliferation of hematologic and solid tumors and their protective environment. The [68Ga]Gallium based PET agent PentixaFor has demonstrated advanced imaging not only for several different hematologic indications – including leukemia, lymphoma, and multiple myeloma – but also for solid tumors like adrenocortical carcinoma and small cell lung cancer. In addition, other disease conditions, such as atherosclerosis, myocardial infarction, splenosis and stroke can be visualised with this tracer.
PentixaPharm, founded in 2019, is a radiopharmaceutical development company committed to developing the innovative theranostic pair PentixaFor and PentixaTher. PentixaFor and PentixaTher are two-small peptide-based radiopharmaceuticals, which specifically target the CXCR4-receptor.