Plus Therapeutics, Inc., a clinical-stage pharmaceutical company focusing on the development of targeted radiotherapeutics for rare cancers, has announced FDA clearance to proceed with a Phase 1 clinical trial of Rhenium-186 Obisbemeda for the treatment of recurrent glioblastoma (rGBM). The study will evaluate the safety and determine the optimal dose of the drug when administered via convection-enhanced delivery (CED). This marks a significant step forward in the development of a novel treatment option for patients with this aggressive and difficult-to-treat brain cancer.
Glioblastoma is the most common and aggressive form of primary brain cancer, with a high rate of recurrence despite standard treatments like surgery, radiation, and chemotherapy. The prognosis for patients with recurrent glioblastoma remains poor, highlighting the urgent need for innovative therapeutic strategies.
Rhenium-186 Obisbemeda is an investigational radiotherapeutic that utilizes a targeted approach to deliver radiation directly to cancer cells. The drug consists of a radioactive isotope, Rhenium-186, linked to a carrier molecule designed to bind to specific targets on tumor cells. This targeted delivery aims to minimize damage to surrounding healthy tissue while maximizing the therapeutic effect on the tumor.
The Phase 1 trial is designed as an open-label, dose-escalation study. Patients with recurrent glioblastoma who have failed standard therapies will be enrolled. The primary objective of the trial is to assess the safety and tolerability of Rhenium-186 Obisbemeda and to determine the maximum tolerated dose (MTD) when administered via CED. Secondary endpoints include evaluating the drug's pharmacokinetic profile and assessing preliminary evidence of anti-tumor activity.
Convection-enhanced delivery (CED) is a method of drug delivery that involves the direct infusion of therapeutic agents into the brain using surgically implanted catheters. This technique allows for more precise and uniform distribution of the drug within the tumor, potentially improving its effectiveness while minimizing systemic exposure and associated side effects.
"This FDA clearance is an important milestone for Plus Therapeutics and for patients with recurrent glioblastoma," said Marc Hedrick, M.D., President and CEO of Plus Therapeutics. "We believe that Rhenium-186 Obisbemeda has the potential to offer a new and effective treatment option for this devastating disease, and we are eager to begin this Phase 1 trial and advance its clinical development."
The company anticipates initiating the Phase 1 trial in the coming months at leading cancer centers. Further details regarding the trial design and patient eligibility criteria will be available on clinicaltrials.gov.
