Cantex Pharmaceuticals Announces Initiation of an Investigator-Initiated Phase 2 Clinical Trial Investigating Azeliragon Combined with Stereotactic Radiosurgery for the Treatment of Brain Metastases

WESTON, Fla., Aug. 28, 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 the initiation of a Phase 2 clinical trial to assess the safety and effectiveness of Cantex's azeliragon combined with stereotactic radiosurgery in patients with brain metastases. Cantex's azeliragon, currently also in Phase 2 development for the treatment of other major cancers, complications of cancer treatment and the treatment of other life-threatening illnesses, inhibits the receptor for advanced glycation end products (known as RAGE), is orally administered and is taken once daily.

"We are very excited to initiate enrollment into this important clinical trial. With the initiation of this Phase 2 clinical trial, Cantex expands the cancer indications for which azeliragon is being investigated, which now include active Phase 2 clinical trials in glioblastoma, breast cancer, pancreatic cancer, and a phase 2/3 clinical trial in hospitalized COVID-19 patients to prevent acute kidney injury, accelerating azeliragon's development as a treatment of very aggressive and difficult to treat cancers and other illnesses," said Stephen G. Marcus, M.D., Chief Executive Officer of Cantex.

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 from lung and breast cancer).

"Brain metastases are a common complication of cancer and often are treated with stereotactic radiosurgery in the upfront setting," said Rupesh Kotecha, M.D., principal investigator of the investigator-initiated trial and Chief of Radiosurgery and Director of Central Nervous System Metastasis at Miami Cancer Institute, part of Baptist Health South Florida. "This investigator-initiated Phase 2 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 enhance the effectiveness of radiation therapy."

Cantex's azeliragon inhibits RAGE interactions 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, triggers inflammatory responses, which may worsen brain swelling associated with radiation therapy. This clinical trial is designed to determine whether Cantex's 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.

About Azeliragon
Azeliragon is an orally administered capsule, taken once daily, that inhibits interactions of 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 whom 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 also has ongoing Phase 2 clinical trials in newly diagnosed glioblastoma, neoadjuvant therapy of breast cancer, and metastatic pancreatic cancer, and an ongoing Phase 2/3 clinical trial in hospitalized COVID-19 patients to prevent acute kidney injury. These trials are based on azeliragon's robust pre-clinical 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) for the treatment of type 1 diabetes. To learn more please visit vtvtherapeutics.com.

Contacts:

Tiberend Strategic Advisors, Inc.
Investors
Daniel Kontoh-Boateng
+1 862-213-1398
[email protected]

Media
Casey McDonald
+1 646-577-8520
[email protected]

Cantex Pharmaceuticals, Inc.:
Stephen G. Marcus, M.D.
+1 954-315-3660
[email protected]

Juan F. Rodriguez
+1 954-315-3660
[email protected]

SOURCE Cantex Pharmaceuticals, Inc.