Cantex and Allegheny Health Network Announce Initiation of a Phase 1/2 Study of Azeliragon in Patients Refractory to First-Line Treatment of Metastatic Pancreatic Cancer

Weston, FL and Pittsburgh, PA – 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, today announced 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.

“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.

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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.

About Cantex Pharmaceuticals, Inc.

Cantex Pharmaceuticals, Inc. is a privately held, clinical stage pharmaceutical company focused on developing transformative therapies for cancer and other life-threatening medical conditions for which new treatments are urgently needed. For more information, please visit www.cantex.com.

About the Allegheny Health Network – and the AHN Cancer Institute

Allegheny Health Network (AHN.org) is a western Pennsylvania-based integrated healthcare system that serves patients from across a five-state area that includes western Pennsylvania and the adjacent regions of Ohio, West Virginia, Maryland, and New York. The Network’s Cancer Institute employs more than 200 physicians and 500 oncology professionals who provide a complete spectrum of oncology care at 24 affiliated oncology clinics, including access to state-of-the-art technologies and new therapies being explored in hundreds of clinical cancer trials. The Cancer Institute has the only cancer program in the Pittsburgh region accredited as an Integrated Network Cancer Program by the American College of Surgeons Commission on Cancer, and its radiation oncology program is the largest in the country accredited by the American Society for Radiation Oncology. AHN Cancer Institute is a Quality Oncology Practice Initiative certified practice and is accredited by the Foundation for Accreditation of Cellular Therapy, National Accreditation Program for Breast Centers and the National Accreditation Program for Rectal Cancer. To schedule an appointment with an AHN oncologist, please call 412.DOCTORS or visit www.ahn.org/find-a-doctor.