WESTON,
Fla., Jan. 9, 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, 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
glioblastoma.
Glioblastoma is a highly malignant primary brain tumor for which
current therapeutic options provide a limited life extension
benefit. New treatments of glioblastoma are urgently needed.
Azeliragon is an orally administered small molecule, taken once
daily, that inhibits the receptor for advanced glycation
endproducts (known as RAGE) interactions with certain ligands,
including HMGB1 and S100 proteins in the glioblastoma
microenvironment. By preventing interaction of RAGE with these
ligands, azeliragon may inhibit glioblastoma and overcome its
resistance to effective treatment. Azeliragon was originally under
development for Alzheimer's disease by the company from which
Cantex licensed it. 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 is also developing azeliragon for the
treatment of other major cancers in need of improved treatments
where RAGE has been implicated in disease progression and in
complications of cancer treatment.
"Receiving FDA orphan drug status for azeliragon highlights the
significant unmet need for novel treatment options for patients
with glioblastoma, the most common and lethal primary brain
cancer," commented Stephen G. Marcus, M.D., Chief Executive
Officer of Cantex. "This designation validates our continued
commitment to developing new treatment options for patients with
glioblastoma, as well as for other cancers and their complications,
including breast cancer, cancer chemotherapy related cognitive
decline, pancreatic cancer, and cancers, such as breast and lung
cancer, that have metastasized to the brain."
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, previously known as TTP488, is an orally active,
small molecule, antagonist of the receptor for advanced glycation
endproducts (RAGE) licensed by Cantex Pharmaceuticals, Inc. from
vTv Therapeutics Inc. (NASDAQ: VTVT). vTv Therapeutics discovered
azeliragon and developed it into phase 3 clinical trials. A broad
range of evidence suggests 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 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.
Contact Data
Stephen G.
Marcus, M.D.
+1 954-315-3660
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SOURCE Cantex Pharmaceuticals, Inc.
