On September 18, 2023 Cantex Pharmaceuticals, Inc., a clinical stage pharmaceutical company focused on developing transformative therapies for cancer and other life-threatening medical conditions for which new treatments are urgently needed, and Lenox Hill Hospital’s Department of Neurological Surgery reported the initiation of a Phase 2 study to assess the safety and effectiveness of azeliragon in combination with radiation therapy as a treatment for newly diagnosed unmethylated glioblastoma (Press release, Cantex, SEP 18, 2023, View Source [SID1234635221]).
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Glioblastoma is a highly malignant primary brain tumor for which current therapeutic options provide a limited life extension benefit. Unmethylated glioblastoma does not respond well to chemotherapy, further limiting the available treatment options for patients with this severe form of cancer. New treatments for glioblastoma are urgently needed.
"We are pleased to announce the initiation of patient enrollment at Lenox Hill Hospital, a world-class provider of neurosurgical and cancer treatment, into this important Phase 2 clinical study," said Stephen G. Marcus, M.D., Cantex’ Chief Executive Officer. "Azeliragon inhibits activation of a receptor known as ‘RAGE’ on the surface of glioblastoma cells. RAGE has been implicated in the progression of glioblastoma and its resistance to radiation therapy. In pre-clinical studies, azeliragon enhanced the effectiveness of radiation therapy. With this study, we seek to enhance the effectiveness of radiation therapy and delay or prevent disease progression."
"Through the initiation of this Phase 2 study at Lenox Hill Hospital, we seek to explore the safety and potential efficacy of azeliragon as a treatment of unmethylated glioblastoma, which is less responsive to chemotherapy. This potential therapy may be an option for patients who lack many other treatment alternatives," said John Boockvar, MD, Vice Chair and Professor of Neurosurgery at Lenox Hill Hospital, and adjunct Professor at Cold Spring Harbor Laboratory.
About Azeliragon
Azeliragon is an orally administered capsule, taken once daily, that inhibits interactions of the receptor for advanced glycation end products (known as RAGE) with certain ligands, including HMGB1 and S100 proteins in the tumor microenvironment. Azeliragon was discovered by and originally under development for Alzheimer’s disease by vTv Therapeutics Inc. (NASDAQ: VTVT) from whom Cantex licensed worldwide rights to azeliragon. Clinical safety data from these trials, involving more than 2000 individuals dosed for periods up to 18 months, indicate that azeliragon is very well tolerated. Cantex also has ongoing clinical trials in newly diagnosed glioblastoma, brain metastasis, neoadjuvant therapy of breast cancer, metastatic pancreatic cancer, and hospitalized COVID patients to prevent acute kidney injury. These trials are based on robust pre-clinical data as well as the extensive clinical safety information from randomized placebo-controlled clinical trials.