CANTEX PHARMACEUTICALS AND LENOX HILL HOSPITAL ANNOUNCE INITIATION OF A PHASE 2 STUDY OF RAGE INHIBITOR AZELIRAGON AS A FRONT-LINE TREATMENT FOR UNMETHYLATED GLIOBLASTOMA

Initiation of Clinical Study at Lenox Hill Hospital Seeks to Provide New Option for Treatment of Newly Diagnosed Unmethylated Glioblastoma

WESTON, Fla. and NEW YORK, Sept. 18, 2023 /PRNewswire/ -- 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 announced 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.

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.

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 Northwell Lenox Hill Hospital
Northwell Lenox Hill Hospital is a 450-bed, fully accredited, acute care hospital located on Manhattan's Upper East Side with a national reputation for outstanding patient care and innovative medical and surgical treatments. U.S. News & World Report has ranked Lenox Hill among the nation's best for cardiology and heart surgery; orthopedics; obstetrics and gynecology; neurology and neurosurgery; geriatrics; pulmonology and lung surgery; ear, nose and throat; diabetes and endocrinology; and cancer. In addition, the hospital received designations from U.S. News for its performance in 19 procedures and conditions. Lenox Hill was also named among 'America's 50 Best Hospitals' by Healthgrades, placing it in the top 1 percent of all hospitals nationwide. For more information, go to www.lenoxhill.northwell.edu.

About vTv Therapeutics Inc.
vTv Therapeutics Inc. is a clinical stage biopharmaceutical company focused on developing oral, small molecule drug candidates, led by cadisegliatin (TTP399) for the treatment of type 1 diabetes. To learn more please visit vtvtherapeutics.com.

Contact Data:

Cantex Pharmaceuticals, Inc.

Stephen G. Marcus, M.D.
+1 954-315-3660
[email protected]

Juan F. Rodriguez
+1 954-315-3660
[email protected]

Tiberend Strategic Advisors, Inc.

Investors
Daniel Kontoh-Boateng
(862) 213-1398
[email protected]

Media
Casey McDonald
+1 646-577-8520
[email protected]

Lenox Hill Hospital

Tamika Wong
+1 212-434-4836
[email protected]

SOURCE Cantex Pharmaceuticals, Inc.