On August 29, 2022 Plus Therapeutics, Inc. (Nasdaq: PSTV), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported an update following receipt of formal minutes from a Type C meeting with the U.S. Food and Drug Administration (FDA) specific to Chemistry, Manufacturing and Controls (CMC) (Press release, PLUS THERAPEUTICS, AUG 29, 2022, View Source [SID1234618735]). The meeting focused on the Company’s Current Good Manufacturing Practice (cGMP) clinical and commercial manufacturing process for its lead investigational targeted radiotherapeutic, BMEDA-chelated Rhenium-186 NanoLiposome (186RNL), for recurrent glioblastoma (GBM).
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The FDA indicated agreement with the Company’s proposed application of cGMP guidance for radiotherapeutics, small molecule drug products and liposome drug products for Plus Therapeutics’ novel 186RNL in support of ongoing and future glioblastoma clinical trials, manufacturing scale up and commercialization. Alignment with the FDA includes support of the Company’s proposed controls and release strategy for the new drug substance and new drug product. The Company expects that this FDA feedback will apply to 186RNL used in other clinical development programs, including leptomeningeal metastases and pediatric brain cancer.
"We had a constructive and detailed discussion with the FDA and obtained clarity on various key CMC requirements to mitigate the risk of future delays for potential Investigational New Drug and New Drug Applications," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "The Company remains on track, on time and on budget to have cGMP 186RNL available in the second half of 2022 for all ongoing and planned ReSPECT clinical trials."