Tuesday, August 29, 2023
Cantex Pharmaceuticals, a clinical-stage pharmaceutical company focused on developing innovative therapies for cancer and life-threatening conditions, has announced the initiation of a Phase 2 clinical trial. The trial aims to assess the effectiveness and safety of Cantex's drug, azeliragon, in combination with stereotactic radiosurgery for patients with brain metastases. Azeliragon, currently undergoing Phase 2 development for various cancers and complications of cancer treatment, inhibits the receptor for advanced glycation end products (RAGE). The drug is administered orally and taken once daily.
Dr. Stephen G. Marcus, the CEO of Cantex, expressed enthusiasm for the trial's commencement, noting its potential significance. The Phase 2 trial expands the scope of cancers that azeliragon is being investigated for, including glioblastoma, breast cancer, pancreatic cancer, and a Phase 2/3 trial for preventing acute kidney injury in COVID-19 patients. This broadened focus accelerates azeliragon's potential as a treatment for aggressive cancers and serious illnesses.
Brain metastases, the most common type of brain cancer, affect over 150,000 individuals annually, often stemming from primary cancers such as lung and breast cancer.
Dr. Rupesh Kotecha, the lead investigator of the trial and Chief of Radiosurgery and Director of Central Nervous System Metastasis at Miami Cancer Institute, emphasized the role of stereotactic radiosurgery in treating brain metastases. The Phase 2 trial introduces azeliragon's unique mechanism of action, potentially enhancing the efficacy of radiation therapy and reducing inflammation.
Azeliragon disrupts RAGE interactions with specific ligands like HMGB1 and S100 proteins in the cancer microenvironment. Notably, S100A9, released from microenvironment cells in brain metastases, attaches to RAGE receptors on cancer cells, rendering them resistant to radiation. Azeliragon's intervention could restore sensitivity to radiation therapy and curb inflammatory responses triggered by RAGE interactions, thus reducing brain swelling associated with radiation therapy. The trial aims to determine if azeliragon, alongside stereotactic radiosurgery, can minimize the need for dexamethasone, a potent steroid used to control brain swelling, while improving radiation therapy's effectiveness for brain metastases.
Azeliragon, an orally administered capsule taken daily, was initially developed by vTv Therapeutics for Alzheimer's disease. Cantex holds global rights to azeliragon and has demonstrated its safety through extensive clinical trials involving over 2000 participants dosed for up to 18 months. Cantex is also conducting Phase 2 trials for newly diagnosed glioblastoma, neoadjuvant breast cancer therapy, metastatic pancreatic cancer, and a Phase 2/3 trial for preventing acute kidney injury in hospitalized COVID-19 patients. These trials rely on azeliragon's robust preclinical data and its well-established safety profile from randomized placebo-controlled clinical trials.
