WESTON,
Fla., March 6, 2023 /PRNewswire/ -- Cantex
Pharmaceuticals, Inc., a clinical-stage pharmaceutical company
focused on developing transformative therapies for cancer and
other life-threatening medical conditions, and Baptist Health Miami
Cancer Institute, part of Baptist Health Cancer Care, the largest
cancer program in South Florida,
announced today that the U.S. Food and Drug Administration (FDA)
has issued a "Study May Proceed" letter for the Miami Cancer
Institute's investigator initiated clinical trial to assess the
safety and effectiveness of azeliragon combined with stereotactic
radiosurgery in patients with brain metastases.
"Brain metastases are a devastating diagnosis for
many people in their cancer journey," said Rupesh Kotecha, M.D., the principal investigator
of the trial and Chief of Radiosurgery in the Department of
Radiation Oncology and Director of the Central Nervous System
Metastasis program at Miami Cancer Institute. "At Miami Cancer
Institute, we are fortunate in that we have the latest radiotherapy
technologies used to treat brain metastases. Stereotactic
radiosurgery allows the radiation oncologist to deliver an intense,
precisely targeted dose of radiation to tumor cells inside the
brain while sparing healthy surrounding tissues including the brain
itself, arteries, nerves and other important
structures. Typically, patients receive corticosteroids along
with the treatment to reduce the risk of peri-tumoral edema and
inflammation. The clinical trial of azeliragon, with its
differentiated mechanism of action, will offer patients a unique
approach to the treatment of brain metastases that may protect
against inflammation as well as potentiate radiation response in
the tumor. This clinical trial represents a novel way of enhancing
the effectiveness of radiation therapy of cancer."
Cantex's azeliragon is an orally administered
small molecule, taken as a pill once daily, that is being studied
as a treatment for glioblastoma, brain metastases, and other
cancers. Azeliragon inhibits interactions of the receptor for
advanced glycation end products (known as RAGE) with certain
ligands, including HMGB1 and S100 proteins in the cancer
microenvironment. S100A9, a protein released from cells within the
microenvironment of brain metastasis, binds to RAGE receptors on
the surface of cancer cells, making them resistant to the
effectiveness of radiation treatments. Azeliragon blocks the
interaction of S100A9 with RAGE, potentially restoring sensitivity
to radiation therapy. In addition, interaction of RAGE with
proteins that bind to it, trigger inflammatory responses, which may
worsen brain swelling associated with radiation therapy. The Miami
Cancer Institute's investigator-initiated trial is designed to
determine whether azeliragon, when administered in combination with
stereotactic radiosurgery, can prevent or eliminate the need for a
powerful steroid, dexamethasone, to control brain swelling as well
as improve the effectiveness of radiation therapy to treat brain
metastases.
Brain metastases occur when cancer spreads from
their original location. Brain metastases are the most common type
of cancer in the brain, with over 150,000 people each year
developing brain metastasis from their primary cancer (most
commonly lung and breast cancer).
"We are excited to receive FDA authorization to
proceed with this trial. With this approval, Cantex expands the
cancer indications for which azeliragon is being investigated,
including glioblastoma, breast cancer, and pancreatic cancer,
furthering our work to better understand azeliragon as a treatment
of very aggressive and difficult to treat cancers," said
Stephen G. Marcus, M.D., Chief
Executive Officer of Cantex. "The team of renowned oncologists at
Miami Cancer Institute is committed to expanding innovative,
cutting-edge tools for cancer treatment as indicated by their
interest in RAGE inhibition and treatment of brain metastases."
Cantex recently announced that the FDA had
provided the company with a "Study May Proceed" letter to assess
azeliragon for the treatment of glioblastoma, the most common
primary brain cancer. Azeliragon was also recently granted FDA
Orphan Drug Designation for the treatment of glioblastoma.
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.
About Miami Cancer Institute
Miami Cancer Institute brings to South Florida access to personalized clinical
treatments and comprehensive support services delivered with
unparalleled compassion. No other cancer program in the region has
the combination of cancer-fighting expertise and advanced
technology—including the first proton therapy center in
South Florida, Latin America and the Caribbean, and one of the only radiation
oncology programs in the world with each of the newest radiation
therapies in one place—to diagnose and deliver precise cancer
treatments that achieve the best outcomes and improve the lives of
cancer patients. The Institute offers an impressive roster of
established community oncologists and renowned experts, clinical
researchers and genomic scientists recruited from the nation's top
cancer centers. Selected as Florida's only member of the Memorial Sloan
Kettering Cancer (MSK) Alliance, Miami Cancer Institute is part of
a meaningful clinical collaboration that affords patients in
South Florida access to innovative
treatments and ensures that the standards of care developed by
their multidisciplinary disease management teams match those at
MSK. For more information, please
visit https://cancer.baptisthealth.net/miami-cancer-institute.
Miami Cancer Institute is part of Baptist Health
Cancer Care, the largest cancer program in South Florida, with locations from the Florida
Keys to the Palm Beaches.
Contacts:
Miami Cancer Institute, part of Baptist Health
Cancer Care
Bianca Hernandez
305.846.6118
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
View original content to download
multimedia:https://www.prnewswire.com/news-releases/cantex-and-miami-cancer-institute-announce-fda-clearance-for-a-clinical-trial-investigating-azeliragon-combined-with-stereotactic-radiosurgery-for-the-treatment-of-brain-metastases-301762892.html
SOURCE Cantex Pharmaceuticals, Inc.
