WESTON,
Fla., May 20, 2024 /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, announced today that the U.S. Food and Drug
Administration (FDA) has granted Orphan Drug Designation to Cantex'
azeliragon, a well-tolerated once-a-day pill, for the treatment of
pancreatic cancer. This new azeliragon orphan drug designation adds
to azeliragon's previous orphan drug designation for the treatment
of glioblastoma, received in early 2023.
Pancreatic cancer, unless controlled at its earliest stages,
often spreads to local tissues and to distant organs. Although
surgery can be curative if pancreatic cancer is diagnosed at its
very earliest stages, once the cancer has spread to distant organs,
the current treatment has some, although limited, efficacy. New
treatments are clearly needed.
Cantex has an ongoing clinical trial studying the safety and
efficacy of azeliragon in patients refractory to first-line
treatment of metastatic pancreatic cancer. This clinical trial is
enrolling metastatic pancreatic cancer patients in several
world-class cancer treatment centers in the U.S.
"Receiving FDA orphan drug status for azeliragon for the
treatment of pancreatic cancer underscores the significant unmet
need for novel treatment options for patients with pancreatic
cancer, particularly for those patients with locally advanced,
unresectable, or metastatic disease," commented Stephen G. Marcus, M.D., Chief Executive Officer
of Cantex. "This designation strengthens our continued commitment
to developing new azeliragon treatment options for patients with
pancreatic cancer, as well as for other cancers and their
complications, including glioblastoma, brain metastasis and breast
cancer."
FDA Orphan Drug Designation provides Cantex with seven years of
azeliragon marketing exclusivity from the time of product launch
for the orphan indication, and several other important benefits,
including assistance in the drug development process, tax credits
for clinical costs, and exemptions from certain FDA fees.
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 which 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 has ongoing Phase 2 clinical trials in pancreatic cancer,
glioblastoma, brain metastasis, breast cancer, and a Phase 3 trial
in hospitalized patients with pneumonia. 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 vTv Therapeutics Inc.
vTv Therapeutics Inc. is a clinical stage biopharmaceutical
company focused on developing oral, small molecule drug candidates,
led by cadisegliatin (TTP399), a potentially transformative
treatment for the reduction of hypoglycemic episodes in type 1
diabetes patients. To learn more please visit
vtvtherapeutics.com.
Contact Data:
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
Tiberend Strategic Advisors, Inc.
Investors
Daniel Kontoh-Boateng
+1 862-213-1398
dboateng@tiberend.com
Media
Casey McDonald
+1 646-577-8520
cmcdonald@tiberend.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/cantex-pharmaceuticals-receives-fda-orphan-drug-designation-for-azeliragon-for-the-treatment-of-pancreatic-cancer-302150254.html
SOURCE Cantex Pharmaceuticals, Inc.