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May 20, 2024 12:00 PM

WESTON, Fla., May 20, 2024 /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 pancreatic cancer. This new azeliragon orphan drug designation adds to azeliragon's previous orphan drug designation for the treatment of glioblastoma, received in early 2023.

Pancreatic cancer, unless controlled at its earliest stages, often spreads to local tissues and to distant organs. Although surgery can be curative if pancreatic cancer is diagnosed at its very earliest stages, once the cancer has spread to distant organs, the current treatment has some, although limited, efficacy. New treatments are clearly needed.

Cantex has an ongoing clinical trial studying the safety and efficacy of azeliragon in patients refractory to first-line treatment of metastatic pancreatic cancer. This clinical trial is enrolling metastatic pancreatic cancer patients in several world-class cancer treatment centers in the U.S.

"Receiving FDA orphan drug status for azeliragon for the treatment of pancreatic cancer underscores the significant unmet need for novel treatment options for patients with pancreatic cancer, particularly for those patients with locally advanced, unresectable, or metastatic disease," commented Stephen G. Marcus, M.D., Chief Executive Officer of Cantex. "This designation strengthens our continued commitment to developing new azeliragon treatment options for patients with pancreatic cancer, as well as for other cancers and their complications, including glioblastoma, brain metastasis and breast cancer."

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 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 these trials, involving more than 2000 individuals dosed for periods up to 18 months, indicate that azeliragon is very well tolerated.

Cantex has ongoing Phase 2 clinical trials in pancreatic cancer, glioblastoma, brain metastasis, breast cancer, and a Phase 3 trial in 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 clinical stage biopharmaceutical company focused on developing oral, small molecule drug candidates, led by cadisegliatin (TTP399), a potentially transformative treatment for the reduction of hypoglycemic episodes in type 1 diabetes patients. To learn more please visit vtvtherapeutics.com.

Contact Data:

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

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

Tiberend Strategic Advisors, Inc.

Daniel Kontoh-Boateng
+1 862-213-1398
[email protected]

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

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SOURCE Cantex Pharmaceuticals, Inc.


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