WESTON, Fla. and ANN ARBOR, Mich., Sept. 27, 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 Michigan Medicine, a part of the University of Michigan and one of the nation's leading academic medical centers, announced today the initiation of a randomized, double-blind, placebo-controlled, multicenter, Phase 3 pivotal clinical trial to evaluate the safety and efficacy of Cantex's azeliragon in decreasing the incidence of acute kidney injury and other life-threatening complications in patients hospitalized for COVID-19. The initiation of this Phase 3 pivotal clinical trial follows the completion of the Phase 2 portion of the clinical trial.

Cantex's azeliragon is an orally administered inhibitor of the receptor for advanced glycation end products (known as RAGE). Excessive activation of RAGE has been strongly implicated in life-threatening complications of COVID-19 infection, including lung and kidney failure. In addition, high levels of "suPAR," a protein produced by the immune system, predisposes patients to acute kidney injury during critical illnesses, including severe COVID-19. In human preclinical studies, suPAR's effects are blocked by azeliragon.

"The COVID-19 pandemic has impressed on us the importance of modulating the immune system as a strategy to treat inflammatory diseases. New targets and therapies are needed. Azeliragon, with its anti-suPAR activity, may prove to be a promising drug for several conditions including COVD-19," said Salim Hayek, M.D., the Medical Director of University of Michigan Health Frankel Cardiovascular Center Clinics. "We are therefore pleased to have initiated this Phase 3 pivotal clinical trial of Cantex's azeliragon to determine its effect on preventing the kidney and lung complications that are a major source of morbidity and mortality from severe COVID-19 infection."

"We are excited to initiate this important azeliragon Phase 3 pivotal clinical trial with Dr. Hayek and his colleagues at Michigan Medicine to determine the safety and efficacy of Cantex's azeliragon in the treatment of patients hospitalized for COVID-19," said Stephen G. Marcus, M.D., Cantex's Chief Executive Officer.  "With the resurgence of COVID-19 cases in the U.S., this azeliragon Phase 3 pivotal clinical trial is a timely addition to the treatment options available for seriously ill patients hospitalized with COVID-19 infection," concluded Dr. Marcus.

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 breast cancer, pancreatic cancer, glioblastoma and brain metastases. These trials are based on azeliragon's robust preclinical 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 Michigan Medicine

At Michigan Medicine, we advance health to serve Michigan and the world. We pursue excellence every day in our five hospitals, 125 clinics and home care operations that handle more than 2.3 million outpatient visits a year, as well as educate the next generation of physicians, health professionals and scientists in our U-M Medical School.

Michigan Medicine includes the top ranked U-M Medical School and University of Michigan Health, which includes the C.S. Mott Children's Hospital, Von Voigtlander Women's Hospital, University Hospital, the Frankel Cardiovascular Center, Kellogg Eye Center, University of Michigan Health West and the Rogel Cancer Center. The U-M Medical School is one of the nation's biomedical research powerhouses, with total research funding of more than $500 million.

More information is available at www.med.umich.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.

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Stephen G. Marcus, M.D.
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