Eckert & Ziegler: Radboud University Medical Center Netherlands to Image First Patient with PENTIXAFOR

Developed by PentixaPharm, PENTIXAFOR is an innovative imaging PET tracer that targets the chemokine-4 receptor (CXCR4) and is used to diagnose various oncological and inflammatory diseases. The Ga-68-based PET radiodiagnostic is expected to have the potential to significantly improve the diagnosis of these disorders and to direct patients to the appropriate therapy.

Primary aldosteronism (PA), also known as Conn’s disease, is an abnormality of the adrenal gland characterised by either a unilateral aldosterone-producing adenoma (APA) or bilateral adrenal hyperplasia (BAH). Regardless of the location of the pathological tissue, adrenal tumours cause hypersecretion of aldosterone, which leads to hypertension and is therefore closely associated with high vascular morbidity. The prevalence of PA in patients with hypertension, about 20 million patients in Germany, is about 5.9 %. The number of unreported cases is even higher due to the complicated and invasive standard diagnosis by adrenal vein sampling (AVS).

The CASTUS study is a clinical research programme aiming to evaluate the accuracy of PENTIXAFOR in the diagnosis of primary aldosteronism. The Ga-68-based PET radiodiagnostic will be used to detect the unilateral or bilateral nature of aldosterone hypersecretion in primary aldosteronism. This distinguishing feature determines patient management and medical therapy. Compared to the previous diagnostic procedure, in which hormone levels are measured on the adrenal gland using a complex invasive catheterisation procedure, PENTIXAFOR is a non-invasive diagnostic method. In order to investigate the potential of PENTIXAFOR, the RUMC is recruiting up to 300 patients.

RUMC has started imaging the first patient with PENTIXAFOR with great success. High-resolution images show the potential of the non-invasive PET radiodiagnostic PENTIXAFOR. One of the investigators of the CASTUS study, Professor J. F. Langenhuijsen explained: "The high sensitivity of PENTIXAFOR allows us to determine the location of the adrenal tumour much more accurately and may replace the previous, invasive gold standard AVS for diagnosis in the future. Further studies are needed to determine the promising prognostic value of PENTIXAFOR at baseline or during treatment evaluation."

"The fact that one of the leading centres in the Netherlands, such as RUMC, has decided to work on PENTIXAFOR itself shows the great interest in finding a new diagnostic for adrenal disease and could pave the way for additional therapeutic alternatives. The CASTUS trial provides PentixaPharm with the opportunity to enter another therapeutic area in addition to its core development strategy in oncology," commented Dr Hakim Bouterfa, founder and managing director of PentixaPharm GmbH. "We are pleased to have Professor J. F. Langenhuijsen, Professor J. Deinum and Professor M. Gotthardt as principal investigators for this study."

Eckert & Ziegler (ISIN DE0005659700, TecDAX), the owner of the rights to the underlying [68Ga]Ga-PentixaFor PET compound, is supporting the RUMC team by providing PENTIXAFOR. In return, Eckert & Ziegler receives access to the study results. PENTIXAFOR is being developed by Eckert & Ziegler subsidiary PentixaPharm GmbH as a highly sensitive diagnostic for a portfolio of haemato-oncological malignancies, including myeloma and lymphoma.

In 2021, the European Medicines Agency (EMA) gave Eckert & Ziegler the green light to jump directly into a phase III clinical trial for PENTIXAFOR, allowing the company to save a number of time-consuming evaluation steps. Since end of December, the Phase III study design has been submitted for review in Amsterdam. However, the EMA recently had to postpone the start of the review, which was scheduled for March 7, 2022, by two months because an "exceptionally high number of applications" faced a pool of reviewers decimated by Corona and its processing capacities were insufficient. The phase III clinical trial is expected to start approximately 5 months after the start of the review and will include about 500 patients in a PAN cancer trial with European participation.

The CASTUS study is sponsored by ZonMW, the Dutch national organisation for health research and innovation in healthcare.