Latest news with #Rhenium
Yahoo
28-03-2025
- Health
- Yahoo
MiRus Siegel™ TAVR: First EFS Cases
ATLANTA, March 28, 2025 /PRNewswire/ -- MiRus is pleased to announce the launch of the US multi-center Early Feasibility Study of the Siegel™ 8-Fr aortic transcatheter heart valve (THV). The first two cases were successfully performed this week by Pradeep K. Yadav MD, Director of Structural Interventions, and Vinod H. Thourani MD, Marcus Chairman of Cardiovascular Surgery, Piedmont Heart Institute, Atlanta. Both patients were discharged without complications the next day. The Siegel valve represents several firsts in TAVR: 8 French delivery sheath allowing less invasive procedures and broader patient access, particularly for women; the only Nickel-free THV allowing treatment of the 20% of Americans suffering from Nickel allergies; precise delivery due to lack of foreshortening and intrinsic commissural alignment; dry porcine pericardial leaflets with anti-calcification treatment and with the valve pre-mounted on the balloon. "Our initial experience is very positive," commented Pradeep K. Yadav, MD. "Siegel is much less invasive then current devices and can be placed very precisely due to the lack of foreshortening. This should lead to lower pacemaker rates. The hemodynamics are excellent due to the radial strength and porcine pericardial leaflets." The combination of low delivery system profile and excellent hemodynamics is made feasible by the unique properties of the Rhenium alloys pioneered by MiRus including high yield strength, fatigue resistance and minimal recoil. "In these first two cases, the Siegel valve performance is impressive," stated Vinod H. Thourani MD, Marcus Chairman of Cardiovascular Surgery and the Marcus Valve Center, Piedmont Heart Institute. "8 French system with such precise placement and low gradients and no PVL is not a combination I ever expected in THV. A THV without nickel is also much needed." About MiRus, is a life sciences company headquartered in Marietta, Georgia that has developed and is commercializing proprietary novel biomaterials, implants and procedural solutions for the treatment of spine, orthopaedic and structural heart disease. Inspired by the pioneering material science of NASA for rocket engines, MiRus has created Rhenium based medical alloys that are transforming medicine by making surgeries less invasive and implants safer and more durable. Find out more information about MiRus at Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, expected timing or results of any clinical trials, ultimate clinical outcome and perceived or actual advantages of the Company's products, market and physician acceptance of the products, intellectual property protection, and competitive offerings could cause actual events to adversely differ from the expectations indicated in these forward looking statements. The Siegel TAVR system is an investigational device and not FDA approved. * MiRus® , Siegel™ are all trademarks of MiRus, LLC. Contact:Pam CowartVP of Clinical Affairspcowart@ 770-861-4804 View original content to download multimedia: SOURCE MiRus Sign in to access your portfolio
Yahoo
10-03-2025
- Business
- Yahoo
Plus Therapeutics Announces Peer-Reviewed Publication in Nature Communications Highlighting Promising Phase 1 Results for Rhenium (186Re) Obisbemeda in Glioblastoma
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 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 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)-728-7222chuang@ in to access your portfolio
