cGMP production of186RNL 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 investigational targeted radiotherapeutic, 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 Pharmaceuticals for Plus Therapeutics’ New 186RNL in Support of Clinical Trials current and future glioblastoma, scaling up manufacturing and marketing. 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 metastasis 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 186RNL development programs for recurrent glioblastoma and leptomeningeal metastases are supported, in part, by the U.S. 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 facts 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 of 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; further evaluation of 186RNL, including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and the expected benefits of such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements due to various factors, including, but not limited to, following: the status of the Company’s product candidates and therapies; the results of the Company’s research and development activities, including uncertainties related to clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional funds, the outcome of the Company’s partnership/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions , product performance, litigation or potential litigation, and competition within the field of cancer diagnostics and therapeutics, among others; and the additional risks described under the heading “Risk Factors” in the Company’s filings with the Securities and Exchange Commission, including in the Company’s annual and quarterly reports. Future events may occur that the Company is unable to predict or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise forward-looking statements to reflect events, trends or circumstances after the date on which they are made, except as required by the Company to do so under the US federal securities laws.
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