On September 26, 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 Allegheny Health Network (AHN), an academic healthcare system serving the diverse greater western Pennsylvania community that provides pioneering medical research and education programs focused on transforming healthcare, reported the initiation of a Phase 1/2 study to assess the safety and efficacy of azeliragon in patients refractory to first-line treatment of metastatic pancreatic cancer (Press release, Cantex, SEP 26, 2023, View Source [SID1234635424]).
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"We are extremely pleased to announce the initiation and patient enrollment at Allegheny Health Network, a world-class provider of cancer treatment, of this important Phase 1/2 clinical study to evaluate the safety and efficacy of azeliragon in patients refractory to first-line treatment of metastatic pancreatic cancer," said Stephen G. Marcus, M.D., Cantex’s Chief Executive Officer.
"Azeliragon inhibits activation of a receptor known as ‘RAGE’ on the surface of cancer and cells in the tumor microenvironment. RAGE has been implicated in the growth and spread of pancreatic and other cancers, their resistance to chemotherapy, and complications stemming from pancreatic and other cancers and related treatments. With this study, we seek to slow the growth and spread of pancreatic cancer while alleviating some of its disabling effects," concluded Dr. Marcus.
"Through the initiation of this Phase 1/2 study at AHN, we seek to explore the safety and efficacy of azeliragon in pancreatic cancer patients who are no longer responding to other treatments. Targeting RAGE with azeliragon, a once-daily oral medication well tolerated in previous studies, greatly merits a clinical trial in this setting," said Nathan Bahary, M.D., Academic Chief of Medical Oncology at Allegheny Health Network Cancer Institute. Amongst his various appointments, Dr. Bahary is a member of the National Cancer Institute (NCI) Pancreatic Task Force, and the NCI’s Eastern Cooperative Oncology Group (ECOG) where he serves on the ECOG GI Steering Committee.
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 Phase 2 clinical trials in newly diagnosed glioblastoma, neoadjuvant therapy of breast cancer, brain metastases in combination with stereotactic radiosurgery, and an ongoing Phase 2/3 clinical trial in hospitalized COVID-19 patients to prevent acute kidney injury. These trials are based on azeliragon’s robust pre-clinical data as well as its extensive clinical safety information from randomized placebo-controlled clinical trials.