NEW YORK — Cantex Pharmaceuticals and Lenox Hill Hospital said on Monday that they have started a Phase II clinical trial evaluating the investigational RAGE inhibitor azeliragon plus radiation in patients with MGMT unmethylated glioblastoma.
Through the Phase II trial, Cantex plans to assess the safety and preliminary efficacy of azeliragon plus radiation among 30 patients whose glioblastoma tumors are IDH-wild-type and have negative MGMT promoter methylation, as determined by a local CLIA-certified laboratory test.
Weston, Florida-based Cantex, which licensed azeliragon from vTv Therapeutics in 2021, is sponsoring the trial. The first patient was enrolled at Lenox Hill Hospital in New York City. The agent is designed to inhibit the interaction between the receptor for advanced glycation end products, known as RAGE, and ligands including HMGB1 and S100 proteins in the tumor microenvironment.
"RAGE has been implicated in the progression of glioblastoma and its resistance to radiation therapy," Cantex CEO Stephen Marcus said in a statement. "With this study, we seek to enhance the effectiveness of radiation therapy and delay or prevent disease progression."
Beyond glioblastoma, Cantex is also studying azeliragon as a potential treatment for brain metastasis and metastatic pancreatic cancer as well as a potential neoadjuvant breast cancer treatment, among other cancers and disease types.