Plus Therapeutics Announces Peer-Reviewed Publication in Nature Communications Highlighting Promising Phase 1 Results for Rhenium (186Re) Obisbemeda in Glioblastoma

Yahoo

10-03-2025

Rhenium (186Re) Obisbemeda demonstrates safety, response, and potential efficacy for glioblastoma (GBM) patients
Patients receiving >100 Gy of Rhenium (186Re) Obisbemeda achieved a median overall survival of 17 months, more than double the 8-month median overall survival with standard of care
HOUSTON, March 07, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) ('Plus' or the 'Company'), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announces the publication of results in a peer-reviewed manuscript titled, "Treatment of Recurrent Glioma by Rhenium (186Re) Obisbemeda (186RNL): a Phase 1 clinical trial" in the peer-reviewed medical journal Nature Communications.
'Peer-reviewed publication of our Phase 1 glioma data in a prestigious, high-impact factor journal is substantial validation for this important clinical program,' said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. 'Based largely on this data, our ReSPECT-GBM Phase 2 trial is currently enrolling patients at leading medical centers, bringing us closer to delivering a much-needed treatment option for this devastating disease.'
Key highlights from the publication:
Twenty-one patients were treated with doses up to 22.3 mCi of Rhenium (186Re) Obisbemeda
No dose-limiting toxicity was observed, and most adverse events were unrelated to the study treatment
Median overall survival (OS) was 11 months, surpassing the standard of care for recurrent glioblastoma, which is approximately 8 months
Median OS was strongly correlated with radiation absorbed dose to the tumor and the percentage of tumor treated
Patients receiving >100 Gy (n=12) had a median OS of 17 months, compared to 6 months for those receiving <100 Gy (n=9) (p=0.001)
Absorbed radiation doses to the tumor were as high as 739.5 Gy and were delivered without significant toxicity, exceeding levels achievable with external beam radiation therapy
The full manuscript can be accessed here.
The ReSPECT-GBM trial is actively enrolling patients; additional information about the ReSPECT-GBM trial can be found here.
About Recurrent Glioblastoma (GBM)
GBM affects approximately 15,000 patients annually in the U.S. and is the most common and lethal form of brain cancer. The average life expectancy with GBM is less than 24 months, with a one-year survival rate of 40% and a five-year survival rate of around 5%. There is no clear standard of care for recurrent GBM and the few currently approved treatments provide only marginal survival benefit and are associated with significant side effects, which limit dosing and prolonged use. Approximately 90% of patients experience GBM tumor recurrence at or near the original tumor location, yet there are no FDA-approved treatments in the recurrent or progressive setting that can significantly extend a patient's life.
About Rhenium (186Re) Obisbemeda
Rhenium (186Re) Obisbemeda is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. Rhenium (186Re) Obisbemeda has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. Rhenium (186Re) Obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).
About Convection-Enhanced Delivery
Convection Enhanced Delivery (CED) is a therapeutic strategy that was developed to facilitate targeted delivery of pharmaceuticals to the brain. The CED procedure involves a minimally invasive surgical exposure of the brain, followed by placement of small diameter catheters directly into the brain tumor.
About Plus TherapeuticsPlus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking StatementsThis presentation contains statements that may be deemed 'forward-looking statements' within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. 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 'potential,' 'anticipating,' 'planning' 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 potential promise of Rhenium (186Re) Obisbemeda including the ability of Rhenium (186Re) Obisbemeda to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company's future performance including the next steps in developing 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 Rhenium (186Re) Obisbemeda; the continued evaluation of Rhenium (186Re) Obisbemeda including through evaluations in additional patient cohorts; the intended functions of the Company's platform and expected benefits from such functions; and the development, utility and potential of the CNSide leptomeningeal metastases diagnostic test.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that 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 cancer diagnostics and therapeutics field, ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms, and material security breach or cybersecurity attack affecting the Company's operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics' business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics' annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC's website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. 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.
Investor ContactCharles Y. Huang, MBADirector of Capital Markets and Investor RelationsOffice: (202)-209-5751 | Direct (301)[e-mail] in to access your portfolio