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.
Contact Data:
Tiberend Strategic Advisors, Inc.
Investors
Daniel
Kontoh-Boateng
(862) 213-1398
dboateng@tiberend.com
Media
Casey McDonald
+1 646-577-8520
cmcdonald@tiberend.com
Cantex Pharmaceuticals, Inc.
Stephen G. Marcus, M.D.
+1 954-315-3660
info@cantex.com
Juan F. Rodriguez
+1 954-315-3660
info@cantex.com
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SOURCE Cantex Pharmaceuticals, Inc.
