PentixaPharm Receives BfArM-Clearance for its Therapeutic to conduct a Clinical Trial in Lymphoma

Phase I with PentixaTher

Würzburg / Berlin (Germany), June 8th, 2023 PentixaPharm GmbH, a developer of innovative radiopharmaceuticals fully owned by Eckert & Ziegler Strahlen- und Medizintechnik AG (ISIN DE0005659700; TecDax) has received the approval from the German Federal Institute for Drugs and Medical Devices (BfArM) to start PTT101, its open-label dose escalation study to evaluate the safety, tolerability, biodistribution and efficacy of PentixaTher.

The Yttrium-90 labelled CXCR4-compound PentixaTher will be tested as a radiotherapeutic against recurrent or refractory primary or isolated secondary central nervous system lymphoma. The phase I/II, dose-finding study will be conducted at the University Hospital in Essen, North Rhine Westphalia, Germany. “After showing up to 90% of CNS lymphoma patients overexpressing the target CXCR4 with the Ga68-labeled tracer PentixaFor in CNS lymphoma patients, we are happy to test now the therapeutic impact when attacking CXCR-4 with [90Y]Y-PentixaTher (yttrium (90Y) anditixafortide). The study will start after getting final endorsement from the German Radiation Safety Department (BfS)“, commented Dr. Hakim Bouterfa, Chief Medical Officer at Eckert & Ziegler.

In addition, radiolabelled PentixaTher has shown outstanding results under named-patient programs in patients with T-cell lymphoma as conducted at the University Hospital Würzburg (DOI: 10.2967/jnumed.122.264207) (1). 

1)  Buck AK, Grigoleit GU, Kraus S, Schirbel A, Heinsch M, Dreher N, Higuchi T, Lapa C, Hänscheid H, Samnick S, Einsele H, Serfling SE, Werner RA. C-X-C Motif Chemokine Receptor 4-Targeted Radioligand Therapy in Patients with Advanced T-Cell Lymphoma. J Nucl Med. 2023 Jan;64(1):34-39. doi: 10.2967/jnumed.122.264207. Epub 2022 Jun 23. PMID: 35738903; PMCID: PMC9841250.

About Eckert & Ziegler
Eckert & Ziegler Strahlen- und Medizintechnik AG with more than 1.000 employees is a leading specialist for isotope-related components in nuclear medicine and radiation therapy. The company offers a broad range of services and products for the radiopharmaceutical industry, from early development work to contract manufacturing and distribution. Eckert & Ziegler shares (ISIN DE0005659700) are listed in the TecDAX index of Deutsche Börse.
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Contact

Anne Lobach, Executive Assistant, PentixaPharm GmbH

anne.lobach@pentixapharm.com