Angionetics Inc. reported that the FDA has granted Fast Track designation for the Phase III clinical investigation of Generx (Ad5FGF-4) cardiovascular angiogenic gene therapy.
Angionetics is a biotechnology company focused on the clinical and commercial development of gene-based bio-therapeutics for the treatment of the almost 1.8 million patients in the U.S. who have late-stage coronary artery disease and refractory angina, as well as other medical conditions due to myocardial ischemia.
Generx was developed as a one-time treatment for improving exercise tolerance in angina patients, a condition that is refractory to standard medical therapy and not amenable to conventional revascularization procedures such as coronary artery bypass surgery and percutaneous coronary intervention and stents. The clinical study is being conducted in the U.S. on men and women with refractory angina. The Generx regulatory dossier on file with the FDA represents one of the most extensive and advanced DNA-based clinical data platforms ever compiled, positioning Angionetics as the world’s leader in the field of angiogenic gene therapy.
Under the FDA Modernization Act of 1997, designation as a Fast Track product means that FDA will take actions, as appropriate, to expedite the development and review of a biologics license application for product approval. The process is designed to facilitate clinical and commercial development and expedite the review of new drugs and biologics that are intended to treat serious conditions that demonstrate the potential to address an unmet medical need.
For more information on Angionetics, please visit the company’s website.