WESTON,
Fla. and ANN ARBOR,
Mich., April 20, 2023 /PRNewswire/ -- Cantex
Pharmaceuticals, Inc., a clinical-stage pharmaceutical company
focused on developing transformative therapies for cancer and
other life-threatening medical conditions, 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 2/3 clinical study to
evaluate the safety and efficacy of azeliragon in decreasing the
incidence of acute kidney injury and other life-threatening
complications in patients hospitalized for COVID-19.

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. A protein produced by the immune system,
known as "suPAR", at high levels predisposes patients to acute
kidney injury during critical illnesses, including severe COVID-19.
In pre-clinical studies, suPAR's effects are blocked by
azeliragon.
"Our research into suPAR's role in health and disease has
indicated that suPAR plays a role in a broad range of
cardiovascular and kidney diseases," said Salim Hayek, M.D., the Medical Director of
University of Michigan Health Frankel
Cardiovascular Center Clinics. "Cantex's azeliragon, by inhibiting
the suPAR signaling that produces harmful effects, has potential
not only as a treatment of severe COVID-19, but also as a treatment
of a broad range of life-altering and life-threatening kidney
diseases in which suPAR clearly plays a role."
"We are pleased to collaborate with Dr. Hayek and his
colleagues at Michigan Medicine on this important clinical trial.
Dr. Hayek is known for his groundbreaking research identifying
suPAR as a causative agent and as an important target for
prevention and treatment of a broad range of acute and chronic
kidney diseases," said Stephen G.
Marcus, M.D., Chief Executive Officer of Cantex. "With this
study initiation, Cantex expands the indications for which
azeliragon is being investigated, beyond numerous major cancer
indications for which new treatments are needed, including primary
and metastatic brain cancer, neoadjuvant therapy of breast cancer,
and metastatic pancreatic cancer, to life-threatening inflammatory
conditions including severe COVID-19 and acute kidney injury in
critically ill patients."
About Azeliragon
Azeliragon, previously known as
TTP488, is an orally active, small molecule, antagonist of the
receptor for advanced glycation end products (RAGE) licensed by
Cantex from vTv Therapeutics Inc. (NASDAQ:VTVT). vTv Therapeutics
discovered azeliragon and carried out phase 3 clinical trials for
Alzheimer's disease. Although these trials did not demonstrate
efficacy in Alzheimer's disease, clinical safety data from these
trials, involving over 2000 patients dosed for periods up to 18
months, indicate that azeliragon is very well tolerated. A broad
range of evidence indicates that RAGE—ligand interactions play a
critical role in cancer and its complications as well as in a range
of inflammatory diseases.
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/.
Tiberend Strategic Advisors, Inc.
Investors
Jon Nugent
+1 205-566-3026
jnugent@tiberend.com
Media
Casey
McDonald
+1 646-577-8520
cmcdonald@tiberend.com
Cantex Pharmaceuticals, Inc.:
Stephen G. Marcus, M.D.
+1 954-315-3660
smarcus@cantex.com
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SOURCE Cantex Pharmaceuticals, Inc.