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Eckert & Ziegler Announces Clinical Trial Notification for Joint Clinical Trial in Japan
Berlin, 12 November 2021. Eckert & Ziegler (ISIN DE0005659700, TecDAX) announced that the Clinical Trial Notification (CTN) of a joint clinical study with Novartis Pharma K.K. (Japan) was accepted by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for 68Ga-PSMA-11, an investigational radioligand imaging agent and 177Lu-PSMA-617, an investigational radioligand therapy in metastatic prostate cancer. Eckert & Ziegler Radiopharma GmbH is manufacturer of the pharmaceutical 68Ge/68Ga generator GalliaPharm(R), which is used to produce the radiopharmaceutical 68Ga-PSMA-11 for 68Ga PET/CT diagnostics. This diagnostic procedure may be used to detect the presence of prostate-specific membrane antigen (PSMA) on prostate cancer cells, enabling localization of tumors. "The start of this clinical trial is another milestone in our strategy and demonstrates our expertise as an isotope service provider to the global pharmaceutical industry," explains Dr Lutz Helmke, Executive Director and responsible for the Medical segment of Eckert & Ziegler. PSMA is found in high concentration on the surface of prostate cancer cells, making it a potentially effective target for imaging. Investigational imaging agent 68Ga-PSMA-11 has been shown to bind selectively to the PSMA receptor, allowing localization of prostate carcinoma. The same principle may also be used for therapy. In this case, PSMA-617 is attached to the therapeutic radioisotope 177Lu. Prostate cancer is the most common cancer among males in Japan, with over 106,000 cases in 2020, a significantly higher incidence than stomach cancer (95,000 new cases) or lung cancer (94,500 new cases) (IARC Global Cancer Observatory, 2020). About Eckert & Ziegler.
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