Plus Therapeutics Announces Commercial Manufacturing Supply Agreement for Its Lead Investigational Drug
Plus Therapeutics (PSTV) has partnered with RadioMedix for the commercial production of Rhenium-186 NanoLiposome (186RNL), a targeted radiotherapeutic for recurrent glioblastoma. This strategic alliance aims to ensure cGMP compliance, facilitating clinical studies slated for mid-2022. 186RNL is designed to effectively deliver radiation to central nervous system tumors. Plus Therapeutics is currently conducting a Phase 1 clinical trial for recurrent GBM, leveraging NIH support.
- Partnership with RadioMedix secures commercial production capabilities for 186RNL.
- 186RNL targets recurrent glioblastoma, which may address a significant medical need.
- Current enrollment in Phase 1 clinical trial for recurrent GBM enhances development prospects.
- The need for FDA compliance adds potential regulatory hurdles.
- Market competition in the radiotherapeutics sector could impact market share.
RadioMedix, Inc. is a key manufacturer and supplier of cGMP radiotherapeutics for late-stage clinical trials and commercial production
RadioMedix will produce cGMP drug product for Rhenium-186 NanoLiposome (186RNL) and may extend to future products under the RNL platform
AUSTIN, Texas, Sept. 02, 2021 (GLOBE NEWSWIRE) -- 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, today announced that it has entered into an agreement with RadioMedix, Inc. (RadioMedix) for the commercial production of the Company’s radiopharmaceuticals.
“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.
About Plus Therapeutics, Inc.
Plus Therapeutics is a clinical-stage pharmaceutical company focused on developing innovative, targeted radiotherapeutics with nanoliposome-encapsulated radionuclides for rare and difficult-to-treat cancers. Central to the Company’s drug development is a unique nanotechnology platform designed to formulate, deliver and commercialize multiple drugs targeting rare cancers and other diseases. The platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at PlusTherapeutics.com and ReSPECT-Trials.com.
About RadioMedix, Inc
RadioMedix is a Houston, Texas-based biotechnology company with 21 CFR 211 compliant cGMP manufacturing and analytical suites for human clinical trials, and commercial phase manufacturing for radiopharmaceuticals. For more information, please visit http://radiomedix.com/
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “will,” “believe,” “plan,” “can,” “enable,” “design,” “intend,” “potential,” “expect,” “estimate,” “project,” “prospect,” “target,” “focus,” “anticipate,” “could,” “should,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the Company’s anticipated expenditures, including research and development, sales and marketing, and general and administrative expenses; anticipated benefits of strategic collaborations and license agreements, intellectual property, FDA approval process and government regulation; the Company’s ability to benefit from the NIH/NCI award for continued clinical development of 186RNL for recurrent glioblastoma; the ability of 186RNL to safely and effectively deliver radiation directly to the tumor at high doses; the Company’s ability to expand clinical testing of 186RNL to additional sites; the potential size of the market for the Company’s product candidates; the Company’s research and development efforts; the Company’s IP strategy; competition; future development and/or expansion of its product candidates and therapies in its markets; the Company’s ability to generate product or development revenue and the sources of such revenue; the amounts that the Company may be obligated to pay under license agreements; the Company’s ability to effectively manage its gross profit margins; its ability to obtain and maintain regulatory approvals; expectations as to the Company’s future performance; the Company’s need for additional financing and the availability thereof; its ability to fully access its equity line with Lincoln Park; any changes to its interest expenses; the Company’s ability to continue as a going concern; its ability to remain listed on the Nasdaq Capital Market; the Company’s ability to repay or refinance some or all of its outstanding indebtedness and its ability to raise capital in the future; expectations as to the impact of recently issued or adopted accounting standards; the Company’s expectations as to the impact of the COVID-19 pandemic on its business and operating results; the Company’s beliefs as to the impact of any liability that may arise as a result of any legal proceedings; and the potential enhancement of the Company’s cash position through development, marketing, and licensing arrangements.
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 following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the regenerative medicine field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future 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 any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
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FAQ
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