On September 2, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a U.S. clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported that it has entered into an agreement with RadioMedix, Inc. (RadioMedix) for the commercial production of the Company’s radiopharmaceuticals (Press release, Cytori Therapeutics, SEP 2, 2021, View Source [SID1234587154]).
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"RadioMedix is a global leader in the development and production of GMP radiopharmaceutical products," said Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics. "This strategic partnership substantially supports our efforts to have fully compliant 186RNL available by mid-2022 for a potential Phase 2/3 clinical study in adults with recurrent glioblastoma (GBM)."
"We are very excited to be the GMP manufacturing arm of Plus Therapeutics and participate in the development of 186RNL, a promising radiotherapeutic for central nervous system tumors. Our investment in state-of-the-art facilities for radiopharmaceutical manufacturing and highly trained experts emphasizes our commitment to delivering positive customer experiences across all phases of radiopharmaceutical development and commercial manufacturing," said Ebrahim S. Delpassand, M.D., Chairman and Chief Executive Officer of RadioMedix.
Under the agreement, RadioMedix will produce cGMP drug product meeting all applicable requirements of the U.S. Food and Drug Administration (FDA) and similar global regulatory entities. This strategic partnership further secures the commercial supply chain for 186RNL and extends to future products under the RNL platform.
186RNL is being developed to treat recurrent GBM, leptomeningeal metastases, and pediatric brain cancer. It has been designed to safely, effectively and conveniently deliver high doses of radiation to rare and central nervous system tumors. Plus Therapeutics is currently enrolling patients with recurrent GBM in the U.S. NIH-supported multi-center ReSPECT-GBM Phase 1 dose-finding clinical trial.