Cantex Pharmaceuticals Granted FDA Orphan Drug Status for Azeliragon in Pancreatic Cancer Therapy
Tuesday, May 21, 2024
Cantex Pharmaceuticals, Inc. made an announcement today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Cantex's azeliragon for treating pancreatic cancer. This designation adds to its prior recognition for glioblastoma treatment in early 2023.
Pancreatic cancer is known for its rapid spread if not caught early. Surgery can be effective in the initial stages, but options become limited once it metastasizes.
Cantex is conducting a clinical trial to assess azeliragon's safety and effectiveness in patients unresponsive to initial treatment for metastatic pancreatic cancer. This trial is taking place in leading U.S. cancer centers.
Dr. Stephen G. Marcus, Cantex's CEO, stressed the importance of FDA orphan drug status for azeliragon in treating pancreatic cancer, highlighting the urgent need for new therapies for advanced or metastatic cases. He reiterated Cantex's commitment to developing azeliragon for various cancers and complications, including glioblastoma, brain metastasis, and breast cancer.
FDA's Orphan Drug Designation grants Cantex seven years of marketing exclusivity for azeliragon from its launch for the orphan indication. It also provides vital support in the drug development process, offers tax credits for clinical expenses, and exempts certain FDA fees.
Azeliragon, taken orally once daily, works by inhibiting interactions of the receptor for advanced glycation end products (RAGE) with specific ligands in the tumor microenvironment. Cantex licensed global rights to azeliragon, originally developed by vTv Therapeutics Inc. for Alzheimer's disease. Clinical safety data from trials involving over 2000 individuals, dosed for up to 18 months, demonstrate its excellent tolerability.
Cantex's ongoing Phase 2 clinical trials in pancreatic cancer, glioblastoma, brain metastasis, and breast cancer, along with a Phase 3 trial in hospitalized pneumonia patients, are based on robust preclinical data and extensive safety information from randomized placebo-controlled trials.
Source: prnewswire.com
