Cantex is developing azeliragon as a
once-a-day pill for the treatment of glioblastoma and other
cancers
WESTON,
Fla., Feb. 27, 2023 /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) reviewed Cantex's
Investigational New Drug application and issued a "Study May
Proceed" letter for Cantex's Phase 2 clinical trial to assess the
safety and therapeutic effect of azeliragon in patients with newly
diagnosed unmethylated glioblastoma treated with standard of care
radiation therapy. Azeliragon was recently granted FDA Orphan Drug
Designation for the treatment of glioblastoma.
"We are very pleased to have received this favorable response
from the FDA enabling Cantex to initiate a Phase 2 clinical trial
of azeliragon for the treatment of glioblastoma," commented
Stephen G. Marcus, M.D., Chief
Executive Officer of Cantex. "Today's news significantly advances
Cantex's azeliragon development program. We look forward to soon
commencing enrollment in this trial given the urgent need for novel
therapies that can better address this devastating disease."
Glioblastoma is the most common primary brain cancer, with
approximately 13,000 cases diagnosed in the U.S. per year.
It is a highly malignant brain tumor for which current
therapeutic options provide a limited life extension benefit. The
median survival after a glioblastoma diagnosis is 15-18 months and
5-year survival is less than 10%. Given this prognosis, new
treatments of glioblastoma are urgently needed.
Azeliragon is an orally administered small molecule, 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 glioblastoma
microenvironment. By preventing interaction of RAGE with these
ligands, azeliragon may inhibit glioblastoma and overcome its
resistance to effective treatment. Cantex is also developing
azeliragon for the treatment of other major cancers not adequately
addressed by current treatments where RAGE has been implicated in
disease progression and in complications of cancer treatment.
Dr. Marcus continued: "The Phase 2 trial of azeliragon in
glioblastoma is one of several promising clinical programs we
continue to advance with azeliragon to treat cancer and other
diseases where RAGE is implicated. Additional azeliragon
indications include pancreatic cancer, breast cancer, and cancers
such as lung cancer and breast cancer that have metastasized to the
brain. These programs highlight the versatility of azeliragon and
our commitment to develop new treatment options for these cancers.
We expect significant progress on these clinical trials during 2023
and 2024."
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 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.
Contacts:
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.
