The U.S. Food and Drug Administration (FDA) granted a fast track designation for the Generx cardiovascular angiogenic gene therapy, which is being developed as a one-time treatment to improve exercise tolerance in patients with angina.
San Diego-based Angionetics, which is testing Generx, announced the news in a press release on Feb. 7.
The FDA grants fast track status for drugs that treat serious conditions and fill an unmet medical need. The designation allows companies and manufactures to have frequent communications throughout the drug’s development and FDA review process.
The Generx gene therapy is intended for patients with angina that is refractory to standard medical therapy and is not amenable to CABG, PCI or stenting. Angionetics plans on evaluating Generx in a phase 3 trial known as AFFIRM.
Angionetics is majority owned by Taxus Cardium Pharmaceuticals Group. The company said that as many as 1.8 million patients in the U.S. have late-stage coronary artery disease and refractory angina.
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.