WESTON,
Fla., Dec. 9, 2024 /PRNewswire/ -- Cantex
Pharmaceuticals, Inc., a clinical-stage pharmaceutical company
focused on developing transformative therapies for cancer and other
life-threatening medical conditions, announced today that the U.S.
Food and Drug Administration (FDA) granted Orphan Drug Designation
to Cantex's azeliragon for the treatment of brain metastasis from
breast cancer. This new azeliragon designation adds to azeliragon's
two other Orphan Drug Designations for the treatment of pancreatic
cancer and glioblastoma, received in mid-2024 and early 2023,
respectively.
Cantex's azeliragon is a well-tolerated compound, administered
orally once-a-day, that inhibits the receptor for advanced
glycation end products (known as RAGE). The binding of RAGE on
cancer cells to S100 proteins and other ligands has been linked to
resistance to radiation, disease progression, and development of
metastasis in breast cancer.
The development of brain metastasis is a life-threatening
complication of breast cancer. Although critically important
life-extending advances in the treatment of brain metastasis from
some forms of breast cancer have recently been made, brain
metastasis from triple-negative breast cancer, an aggressive
subtype of breast cancer, remains a therapeutic challenge greatly
in need of improved treatments.
"Receiving FDA Orphan Drug Designation for azeliragon for the
treatment of brain metastasis from breast cancer highlights a
continued need for new treatment options for these patients,"
commented Stephen G. Marcus, M.D.,
Chief Executive Officer of Cantex. "This designation reflects our
continued commitment to developing new azeliragon treatment options
for patients with life-threatening cancer."
In addition to azeliragon's already issued composition of matter
and other patents, FDA Orphan Drug Designations provide 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 those trials, involving more
than 2000 individuals dosed for periods up to 18 months, indicate
that azeliragon is very well tolerated.
Cantex has ongoing clinical trials in brain metastasis,
glioblastoma, breast cancer, pancreatic cancer, and 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
late-stage biopharmaceutical company focused on developing oral,
small molecule drug candidates. vTv's clinical pipeline is led by
cadisegliatin, a potential adjunctive therapy to insulin for
the treatment of type 1 diabetes patients. vTv and its development
partners are investigating additional indications including type 2
diabetes and other chronic conditions. To learn more please visit
vtvtherapeutics.com.
Contacts:
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
Jon Nugent
+1 646-577-8520
jnugent@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-brain-metastasis-from-breast-cancer-302325038.html
SOURCE Cantex Pharmaceuticals, Inc.