Berlin/Aalborg, 27 October 2022. The University Hospital Aalborg (Denmark) yesterday has imaged the first patient with Eckert and Ziegler’s Gallium (⁶⁸Ga) boclatixafortide (PENTIXAFOR) in an international phase 2 trial. Code named PTF202, the clinical examination tries to measure the predictive potential of the CXCR4 receptor targeting radiotracer for the treatment of central nervous system lymphoma (CNSL). If successful, PENTIXAFOR could change the way that chemotherapy in the future will be prescribed. Among others, it could save CNSL patients who do not respond to treatment from unnecessary hardship.

CNSL are severe tumors with a poor prognosis. They force oncologists to retort to aggressive chemotherapy regimens, which not only have strong side effects, but often fail to even stop tumor growth. In this situation, knowing quickly whether a lymphoma responds to treatment is very valuable. This can be achieved by looking for CXCR4 receptors, which central nervous system tumors often express while progressing. PENTIXAFOR detects such receptors. The information from the innovative radiotracer hence has the potential to significantly increase the options for an improved response and risk assessment and for the optimization of CNSL patient’s therapeutic needs.

“We are very excited to enrol the first patient into the trial." stated Jakob Madsen, MD, Head of the Department for Hematology at the University Hospital Aalborg and principal investigator of the trial. Helle Zacho, MD, Professor at the Nuclear Medicine Department at the University Hospital Aalborg added, "The overall aim of the study is to prospectively and systematically investigate whether PENTIXAFOR can be used for response assessment in CNSL and in addition, can serve as a prognostic marker.”

The PTF202 phase 2 trial, which includes 50 patients from up to eight clinics in Europe and the United States, is expected to be finished by the first quarter of 2025. It is only a part of Eckert & Ziegler’s broader drive to develop the CXCR4 compound. The European Medicine Agency (EMA) is currently reviewing a study design from Eckert & Ziegler for an even larger phase 3 trial with PENTIXAFOR which aims at patients suffering from various other forms of lymphoma. It may include up to 500 participants and could be finished as early as 2025. A decision of the EMA for the go-ahead of this diagnostic radiotracer is expected still within this year.

Further, Eckert & Ziegler is preparing an application for a phase 1 clinical trial in which a modified version of PENTIXAFOR is used to directly attack tumor cells that express the CXCR4 receptor. This modified version of the radiopharmaceutical, Yttrium (⁹⁰Y) anditixafortide, would hopefully show therapeutic effects. The clinical development of the therapeutic, however, is still at the beginning.

Dr. Hakim Bouterfa, Managing Director of Eckert & Ziegler’s subsidiary PentixaPharm, which conducts and sponsors the study, explains: “We are very optimistic about the prospects of radiopharmaceuticals using the CXCR4 receptor. The target has already shown its usefulness in a broad array of academic studies, under compassionate-use, and in investigator-initiated study settings. Scans with radiopharmaceuticals targeting the CXCR4 receptor have been summarized in over 70 publications which include more than 1100 patients. PTF202 is our first step in clinically exploring the potential of this compound.

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