WEST LAFAYETTE, Ind. & MUNICH–(BUSINESS WIRE)–Endocyte, Inc. (NASDAQ Global Market: ECYT), and ITM Isotopen Technologien MÃ¼nchen AG (ITM), a specialized radiopharmaceutical company, today announced a supply agreement under which ITM will supply to Endocyte the medical radioisotope no-carrier-added (n.c.a.) Lutetium (177Lu), EndolucinBetaÂ®, to support clinical supply of 177Lu-PSMA-617 for the Phase 3 VISION trial expected to be initiated by Endocyte in the second quarter of 2018.
â€œITM has been an innovator in the development of the highly purified form of Lutetium-177, an integral component of the 177Lu-PSMA-617 therapy for the investigational treatment of prostate cancer,â€� said Mike Sherman, president and CEO of Endocyte. â€œWe have made a strategic decision to utilize EndolucinBetaÂ® because of its favorable properties which will be important due to 177Lu-PSMA-617â€™s significant potential market opportunity and widespread use. We are pleased to announce this agreement with ITM which will be key to the effective execution of our Phase 3 VISION trial.â€�
â€œWe are delighted to collaborate with Endocyte as they develop this important therapy for patients with prostate cancer,â€� said Steffen Schuster, CEO of ITM. â€œIn the past, promising results have already been observed by combining EndolucinBetaÂ® with disease-specific targeting molecules for Targeted Radionuclide Therapy. It is also being used in investigational medicinal products, for instance in our phase III clinical trial COMPETE. ITM provides a wide-ranging high-tech GMP infrastructure for radioisotope manufacturing as well as an unrivaled logistics network which allows security of supply for EndocyteÂ´s needs at any time.â€�
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EndolucinBetaÂ® is a radiopharmaceutical precursor with a half-life of 6.647 days, usable for radiolabeling of disease-specific carrier molecules. The active substance of EndolucinBetaÂ® is no-carrier-added (n.c.a.) Lutetium (177Lu) chloride. No-carrier-added 177Lu provides the highest specific activity of more than 3,000 GBq/mg at Activity Reference Time (ART), whereas the day of ART can be flexibly selected by the customer. Optimal preconditions for efficient radiolabeling of biomolecules over its entire shelf-life of 9 days after production are ensured. Furthermore EndolucinBetaÂ® exhibits an extraordinary level of radionuclidic purity. EndolucinBetaÂ® does not contain metastable 177mLu, thus, there is no need of logistics and storage of contaminated radioactive waste.
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