Plus Therapeutics

Novel Radiotherapeutic Rhenium Obisbemeda Doubles Survival Time in Glioblastoma Patients

3 months ago

• 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.

Phase 1 Trial Shows Rhenium (186Re) Obisbemeda Doubles Survival in Recurrent Glioblastoma Patients

3 months ago

• 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 Receives FDA Orphan Drug Designation for Novel Lung Cancer Metastasis Treatment

3 months ago

• 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.

FDA Grants Orphan Drug Designation to Rhenium Obisbemeda for Lung Cancer Leptomeningeal Metastases

3 months ago

• 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 Raises $5.7M to Advance Novel Radiotherapy for Leptomeningeal Metastases

3 months ago

• 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.

CNSide CSF Assay Shows Promise in Leptomeningeal Metastases Diagnosis

6 months ago

• 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 Receives FDA Clearance for Phase 1 Trial of Rhenium-186 Obisbemeda in Recurrent Glioblastoma

6 months ago

• 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.

Rhenium-186 Obisbemeda Shows Promise in Recurrent Glioblastoma Trial

8 months ago

• Plus Therapeutics' ReSPECT-GBM Phase 1/2 trial update reveals Rhenium-186 Obisbemeda's favorable safety profile and potential efficacy in recurrent glioblastoma treatment. • The trial achieved a mean Phase 2 absorbed dose of 300 Gy, with 89% of patients exceeding the 100 Gy minimal dose threshold, indicating effective drug delivery. • A statistically significant reduction in tumor volume rate change was observed in patients receiving >100 Gy absorbed dose, suggesting tumor control with sufficient radiation coverage. • The ReSPECT-GBM trial has expanded to new sites, enhancing patient enrollment and accelerating the evaluation of Rhenium-186 Obisbemeda as a therapeutic option.