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Breakthrough Drug Shows Promise in Treating Glioblastoma
A novel therapeutic agent developed at The University of Texas Health Science Center at San Antonio (UT Health San Antonio) has demonstrated the capability to prolong survival in individuals suffering from glioblastoma, which is identified as the most prevalent type of primary brain tumor in adults.
Findings from a recent clinical trial conducted by the university indicate that an innovative drug formulation known as Rhenium Obisbemeda (186RNL) has more than doubled the median survival rates and extended progression-free survival compared to conventional treatment benchmarks, all while showing no significant dose-limiting toxicities.
Dr. Andrew J. Brenner, a leading figure in neuro-oncology research at Mays Cancer Center, commented, “Glioblastoma is characterized by its tendency to recur, resistance to chemotherapy, and the challenges it presents in treatment. There has been a pressing need for effective therapies that target the tumor directly while minimizing harm to surrounding healthy tissues. This trial signals a potential breakthrough, and we are excited about the second phase currently underway, expected to conclude by year’s end.”
As a clinical investigator at the Institute for Drug Development at UT Health San Antonio, Brenner is also the lead author of the study featured in the journal Nature Communications on March 7. The research paper is titled “Convection Enhanced Delivery of Rhenium (186Re) Obisbemeda (186RNL) in Recurrent Glioma: a multicenter, single arm, phase 1 clinical trial.”
The research team included contributors from Mays Cancer Center, UT Southwestern Medical Center in Dallas, Case Western Reserve University, University of Texas MD Anderson Cancer Center, and the trial sponsor Plus Therapeutics Inc. (Nasdaq: PSTV), which is a clinical-stage pharmaceutical company exploring this treatment approach for central nervous system tumors.
Dr. Brenner pointed out that, after the standard interventions, which include surgery, radiation, and chemotherapy, the median survival time for glioblastoma patients is typically only around 8 months, with over 90% facing a recurrence of the tumor at the original site.
The formulation of Rhenium Obisbemeda enables the delivery of substantial activities of the beta-emitting radioisotope rhenium-186 (186Re) encapsulated within specially designed liposomes—tiny artificial vesicles composed of lipid bilayers. Researchers utilized a tailored molecule known as BMEDA to attach the 186Re, ensuring its effective transport within the liposome where it is securely contained.
As part of the phase 1 ReSPECT-GBM trial, the objectives were to establish the maximum tolerated dose of the medication while assessing its safety, overall response, disease progression-free survival, and overall survival rates.
Between March 5, 2015, and April 22, 2021, 21 patients who had undergone one to three prior therapies participated in the study. The treatment involved administering the drug directly to the tumors using advanced neuronavigation techniques and convection catheters.
The trial results exhibited a notable increase in survival compared to historical control data. Not particularly striking was the evidence of significant improvements for patients receiving higher doses, with median survival and progression-free intervals reaching 17 months and 6 months, respectively, for doses exceeding 100 gray (Gy), a measure of radiation dosage.
Furthermore, the research noted no dose-limiting toxic effects, with most reported adverse events considered unrelated to the treatment being studied.
Dr. Brenner concluded, “The successful combination of a novel nanoliposome radiotherapeutic, delivered via advanced techniques such as convection-enhanced delivery and supported by neuronavigational tools, catheter design, and imaging solutions, offers a safe avenue for achieving high radiation doses at tumor sites while minimizing toxicity and potentially enhancing survival outcomes.”
Currently, the second phase of the ReSPECT-GBM trial is actively recruiting patients.
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