Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company. The firm focuses on the development of chemotherapeutics and radio therapeutics for rare cancers that address unmet medical and market needs. Its products include Rhenium NanoLiposome and DocePLUS. The company was founded by Ralph E. Holmes and Christopher J. Calhoun in July 1996 and is headquartered in Austin, TX.
相关临床试验
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成立时间
1996
进行中（未招募）
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33.3%
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- Novartis executives project the radioligand therapy market could reach at least $10 billion for the company alone, with industry leaders expecting tens of billions in total market value. - Theranostic radiopharmaceuticals, which combine diagnostic imaging with targeted radiation therapy, are emerging as "the future" of the field by enabling precise patient selection and treatment monitoring. - Major pharmaceutical companies including Bristol Myers Squibb, Eli Lilly, and AstraZeneca have invested billions in radiopharmaceutical acquisitions, with venture financing reaching a record $408 million in 2023. - Industry experts identify supply chain bottlenecks, imaging capacity constraints, and specialized manufacturing requirements as key challenges that must be addressed before widespread market expansion.
- Plus Therapeutics announced plans to commercially launch its CNSide CSF Assay Platform in the second half of 2025, targeting an underserved CNS cancer diagnostic market estimated at over $6 billion in the U.S. - The CNSide platform demonstrates superior performance compared to current standard of care, with 92% sensitivity and 95% specificity, having influenced treatment decisions in 90% of cases across more than 11,000 tests performed. - The company has established commercial infrastructure including a centralized testing laboratory in Houston and hired experienced leadership to support the rollout, with meaningful revenue contributions expected in fiscal year 2026. - CNS metastases affect up to 30% of adult cancer patients, with leptomeningeal metastases occurring in approximately 5% of cancer patients and carrying a terminal prognosis with 1-year survival of just 7%.
- Plus Therapeutics announced a comprehensive restructuring of its March 2025 equity financing that eliminates the potential issuance of up to 1.5 billion shares of common stock. - The restructuring cancels dilutive warrants and approximately 25 million shares of common stock, significantly reducing stockholder dilution for the CNS cancer-focused radiotherapeutics company. - The company will use 90% of future capital proceeds after July 1, 2025 to repay holders at 115% of their original investment price of $0.66 per share. - Plus Therapeutics has filed to withdraw the related resale registration statement with the SEC as part of this strategic financial restructuring.
- A Phase 1 trial led by UT Health San Antonio demonstrated that Rhenium Obisbemeda more than doubled median survival time to 17 months in recurrent glioblastoma patients receiving high doses, compared to the typical 8-month survival. - The investigational drug uses nanoliposome technology to deliver targeted radiation directly to brain tumors via convection enhanced delivery (CED), bypassing the blood-brain barrier while sparing healthy tissue. - Plus Therapeutics' Rhenium Obisbemeda recently received FDA Orphan Drug Designation for treating leptomeningeal metastases in lung cancer patients, with Phase 2 trials for glioblastoma expected to complete by year-end.
- Plus Therapeutics' Rhenium (186Re) Obisbemeda demonstrated a median overall survival of 17 months in patients receiving >100 Gy radiation dose, significantly outperforming the standard of care's 8-month survival rate. - The Phase 1 trial showed no dose-limiting toxicity even with radiation doses as high as 739.5 Gy to tumors, suggesting a favorable safety profile for this targeted radiotherapeutic approach. - Results published in Nature Communications validate the company's ongoing Phase 2 ReSPECT-GBM trial, potentially offering new hope for glioblastoma patients who currently have limited effective treatment options.
- Plus Therapeutics has secured FDA Orphan Drug Designation for Rhenium (186Re) Obisbemeda, targeting leptomeningeal metastases in lung cancer patients. - The designation marks a significant milestone in addressing the critical unmet need for effective treatments for lung cancer that has spread to the central nervous system. - The company's stock responded positively to the announcement, with shares surging 71% following the FDA's decision.
- Plus Therapeutics receives FDA Orphan Drug Designation for Rhenium Obisbemeda, targeting the treatment of leptomeningeal metastases in lung cancer patients, offering potential market exclusivity and regulatory benefits. - The designation follows successful completion of the ReSPECT-LM Phase 1 single-dose trial, which established the recommended Phase 2 dose for this targeted radiotherapeutic treatment. - The development addresses a critical unmet need, as leptomeningeal metastases affect approximately 5% of cancer patients with limited treatment options and poor survival rates.
- Plus Therapeutics secured $5.7 million in funding through a $3.7M private placement and $2.0M advance from CPRIT to support their Rhenium-186 radiotherapy development for leptomeningeal metastases. - The funding will accelerate the ReSPECT-LM Phase 2a trial of Rhenium (186Re) Obisbemeda and advance development of the CNSide diagnostic test as a key trial endpoint. - The company is developing innovative targeted radiotherapy for CNS cancers, with their lead candidate showing potential for improved outcomes in leptomeningeal metastases, which currently has no FDA-approved treatments.
• The FORESEE trial demonstrated that the CNSide CSF Assay influenced clinical management decisions in over 90% of leptomeningeal metastases (LM) cases, exceeding the target endpoint. • CNSide exhibited enhanced sensitivity in detecting tumor cells (80%) compared to standard CSF cytology (29%) in patients with LM, improving diagnostic accuracy. • The assay identified actionable mutations, such as HER2 amplification, in CSF, impacting 24% of therapeutic selection decisions and demonstrating clinical utility. • High specificity and improved negative predictive value of CNSide aids in ruling out LM, offering a more reliable diagnostic tool for at-risk patients.
- Plus Therapeutics has been granted FDA approval to proceed with a Phase 1 clinical trial evaluating Rhenium-186 Obisbemeda for the treatment of recurrent glioblastoma. - The trial aims to assess the safety and determine the optimal dose of Rhenium-186 Obisbemeda when administered via convection-enhanced delivery (CED) in patients with rGBM. - Rhenium-186 Obisbemeda is a novel radiotherapeutic designed to target and destroy cancer cells through targeted radiation, potentially offering a new treatment option for this aggressive brain cancer. - This Phase 1 trial represents a crucial step in the clinical development of Rhenium-186 Obisbemeda, with the potential to improve outcomes for patients facing limited treatment options for recurrent glioblastoma.
