BELOIT, Wis.--(BUSINESS WIRE)--NorthStar Medical Radioisotopes, LLC (“NorthStar"), a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic and medical imaging applications, is pleased to announce that the first patient has been dosed in a clinical trial using NorthStar’s electron accelerator-produced Cu-67. Administration of the therapeutic dose took place as part of an ongoing Phase I/IIa theranostic clinical trial conducted by Clarity Pharmaceuticals to investigate the safety and efficacy of Cu-67 SARTATE in pediatric patients with high-risk neuroblastoma. The event marks a key milestone in the exclusive Cu-67 supply agreement between both companies.
NorthStar is producing high-activity, high specific-activity and high-purity Cu-67 for use in Clarity’s clinical programs as part of an agreement to exclusively supply Cu-67 to Clarity. Clarity will use NorthStar-produced Cu-67 for its three actively recruiting theranostic clinical trials evaluating the safety and efficacy of 67Cu SARTATE, 67Cu SAR-bisPSMA and 67Cu SAR-Bombesin, as well as future commercialization of its Targeted Copper Theranostic (TCT) products.
NorthStar is the first commercial-scale supplier of this important Cu-67 therapeutic radioisotope, and Clarity leads the world in copper based theranostics. NorthStar’s Cu-67 production process uses highly efficient, environmentally preferable electron accelerator technology and the NorthStar radioisotope has proven suitable for radiolabeling of Clarity’s products using their proprietary SAR Technology platform. The platform is enabled by unique SAR chelators, that are specialized cage-like structures that securely hold copper radioisotopes. Unlike traditional chelators, SAR chelators prevent leakage of copper isotopes into the body. Once securely attached to a targeting molecule, the chelated Cu-67 delivers therapeutic doses of radiation to destroy cancer cells with limited damage to healthy tissue.
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Clarity’s Executive Chairman, Dr. Alan Taylor, stated, “Large-scale manufacture of therapeutic Cu-67 from highly efficient, environmentally preferable electron accelerators is critical to overcome the widespread supply issues in the radiopharmaceutical industry, due to a heavy reliance on a small number of antiquated nuclear reactors. Clarity continues to recruit higher numbers of participants at increasingly higher activities of Cu-67 across all three of our therapeutic clinical trials.”