cGMP production of 186RNL has targeted radiotherapy from the second half of 2022 to support ongoing and future ReSPECT™ clinical trials
AUSTIN, Texas, Aug. 29, 2022 (GLOBE NEWSWIRE) — Plus Therapeutics, Inc. (Nasdaq: PSTV), a clinical-stage pharmaceutical company developing innovative targeted radiation therapies for rare and difficult-to-treat cancers, today announced a updated following receipt of official minutes of a Type C meeting with the United States Food and Drug Administration (FDA) specific to Chemistry, Manufacturing and Controls (CMC). The meeting focused on the company’s current good manufacturing practice (cGMP) clinical and commercial manufacturing process for its lead targeted investigational radiotherapeutic drug, BMEDA Chelated Rhenium-186 Nanoliposome (186RNL), for recurrent glioblastoma (GBM).
The FDA has indicated its agreement with the company’s proposed application of the cGMP guidelines for radiotherapeutics, small molecule pharmaceuticals, and liposome-based pharmaceuticals for Plus Therapeutics’ novel 186RNL to support ongoing and future glioblastoma clinical trials, manufacturing scale-up and commercialization. Alignment with the FDA includes supporting the company’s proposed controls and release strategy for the new drug substance and new drug product. The Company expects these FDA comments to 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 clarification 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 MD, President and CEO of Therapeutic Plus. “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. »
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing innovative, targeted radiation therapies for adults and children with rare and difficult-to-treat cancers. Our proprietary radiotherapy platform focuses on the precise delivery of potent doses of rhenium, a beta-gamma emitting radioisotope that irradiates and kills tumor cells using novel microsphere and nanoliposome technologies. Our radiotherapeutic products are designed and intended to potentially provide increased safety, efficacy and convenience for patients and healthcare providers. The 186The RNL development programs for recurrent glioblastoma and leptomeningeal metastases are supported, in part, by the US National Institutes of Health (NIH) and the Cancer Prevention and Research Institute of Texas (CPRIT), respectively. More information can be found at PlusTherapeutics.com and ReSPECT-Trials.com.
Caution Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of United States securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements can be identified by future verbs, as well as terms such as “designed for”, “will”, “may”, “potential”, “focus”, “prepare”, “next steps”, “possibly”, and similar expressions or their negative forms. These statements are based on certain assumptions and assessments made by management in light of its experience and perception of historical trends, current conditions, expected future developments and other factors it deems appropriate. These statements include, but are not limited to, statements regarding the following: the potential promise of 186RNL, including the ability to 186RNL to safely and effectively deliver radiation directly to the tumor at high doses; expectations regarding the future performance of the Company, including next steps in the development of the Company’s current assets; the Company’s clinical trials, including statements regarding the timing and characteristics of the ReSPECT-GBM, ReSPECT-LM and ReSPECT-PBC clinical trials; possible negative effects of 186RNL; continuous evaluation of 186RNL, including through assessments in additional patient cohorts; and the intended functions of the Company’s platform and the expected benefits of such functions.
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