NEWS / NOVEMBER 25, 2022
Eckert & Ziegler Receives Green Light for Phase III Study with PENTIXAFOR
Phase III with PentixaFor
Würzburg / Berlin (Germany), November 25th, 2022
PentixaPharm GmbH, a 100% subsidiary of Eckert & Ziegler AG (ISIN DE0005659700, SDAX), received green light from the European Medicines Agency (EMA) to conduct a phase III registration study in patients suffering from various forms of Non-Hodgkin-Lymphomas. Following several rounds of scientific advice, the EMA Committee for Medicinal Products for Human Use (CHMP) endorsed a study design presented by PENTIXAPHARM’s management, which envisions treating up to 500 lymphoma patients with the Gallium-68 based radiotracer PENTIXAFOR in about 30 participating European clinics. In its endorsement the CHMP adopted the advice given by the EMA Scientific Advice Working Party, a multidisciplinary group, which comprises delegates from several national European Health Agencies, members of the Committee for Orphan Medicinal Products, the Paediatric Committee, the Committee for Advanced Therapies, and the Pharmacovigilance Risk Assessment Committee. The first treatments with PENTIXAFOR are expected to start in the first half of 2023, subject to approval by national health authorities.
The Executive Board expects to have completed the clinical trials and approval of PENTIXAFOR by the end of 2025 and estimates development costs of EUR 50 million, which will initially be capitalized in the balance sheet and thus not be recognized in the income statement. In addition to the diagnostic agent, Eckert & Ziegler is also developing radiotherapeutics for several hematological indications based on CXCR4 peptides. The Group acquired the global property rights to the CXCR4 receptor addressing agents from the patent licensing office of the Technical University of Munich.