Plus Therapeutics Reveals Encouraging Update on GBM Trial
Plus Therapeutics Updates on ReSPECT-GBM Clinical Trial
Plus Therapeutics, Inc. (NASDAQ: PSTV), a company focused on creating targeted radiotherapeutics for central nervous system cancers, recently provided an update on their ongoing ReSPECT-GBM Phase 1/2 clinical trial. This trial evaluates the effectiveness of Rhenium (186Re) Obisbemeda for treating recurrent glioblastoma, a particularly aggressive form of brain cancer.
Safety and Efficacy Observations
The trial has yielded promising data, consistently demonstrating safety and potential efficacy. Among the 42 patients enrolled across three sites, most have shown a positive response to the treatment with only one notable dose-limiting toxicity reported. This reflects a favorable safety profile amidst the challenging landscape of glioblastoma treatment options.
Trial Details and Current Patient Enrollment
As of the latest update, 19 out of the 42 participants have received treatment at the recommended Phase 2 dosage, which is set at 22.3 mCi infused into small to medium-sized tumor volumes. The average tumor size treated in this trial is 7.5 mL, highlighting an effective method of targeting the administration of Rhenium (186Re) Obisbemeda.
Encouraging Trends in Absorbed Dose
Analysis indicates that 89% of the Phase 2 participants exceeded the minimum dose threshold required for efficacy, achieving an average absorbed radiation dose of 300 Gy. Notably, this increase in absorbed dose correlates with enhanced delivery parameters, such as infusion rate and number of catheters used, underscoring the importance of precise delivery in optimizing treatment outcomes.
Key Highlights from the Trial
A summary of critical findings from the ReSPECT-GBM trial update emphasizes:
- A total of 42 patients have been enrolled, with 19 patients treated at the recommended doses.
- All participants have had recurrent glioblastoma, which has been confirmed histologically.
- Average radiation treatment reached 300 Gy, and a significant portion of patients achieved important drug delivery parameters correlating with survival.
- In Phase 2, most adverse events reported were mild to moderate, suggesting manageable safety concerns.
- A statistically significant tumor volume reduction was observed in patients receiving greater than 100 Gy absorbed doses.
Next Steps for Plus Therapeutics
Marc H. Hedrick, M.D., President and CEO of Plus Therapeutics, shared optimism regarding the trial's progress. The announcement of new clinical trial sites, especially in notable academic institutions, aims to accelerate patient enrollment in both the Phase 1 and Phase 2 arms of the trial.
About Glioblastoma (GBM)
Glioblastoma is a devastating cancer affecting approximately 15,000 individuals in the U.S. each year. Despite ongoing research, survival rates remain low, with most patients facing recurrence shortly after treatment. Currently, effective therapies to extend patient survival are significantly limited.
Innovative Approach with Rhenium (186Re) Obisbemeda
Rhenium (186Re) Obisbemeda represents a novel injectable radiotherapy designed to deliver targeted high-dose radiation directly to tumors. Its unique formulation aims to improve safety and efficacy compared to existing therapies, making it a hopeful option in challenging treatment scenarios like recurrent glioblastoma.
Convection Enhanced Delivery (CED): A Revolutionary Method
CED is a groundbreaking approach facilitating the targeted distribution of drugs to the brain, which involves strategic catheter placements in the tumor. This technique is pivotal in ensuring that therapeutic doses reach affected areas effectively.
Frequently Asked Questions
What is the focus of the ReSPECT-GBM trial?
The ReSPECT-GBM trial evaluates Rhenium (186Re) Obisbemeda for its safety and efficacy in treating recurrent glioblastoma.
How many patients are currently enrolled in the trial?
A total of 42 patients have been enrolled across three clinical trial sites.
What are the recent findings from the trial?
Recent updates indicate that 89% of Phase 2 patients received sufficient doses, showing a favorable safety profile.
Why is Rhenium (186Re) Obisbemeda important?
This treatment is a novel approach that potentially offers higher targeted radiation doses directly to tumors, which may improve outcomes for patients with limited options.
How is Plus Therapeutics advancing this research?
Plus Therapeutics is actively enrolling patients in the trial and expanding their research sites to enhance the pace and reach of the study.
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