Posted by Michael Wonder on 08 Feb 2017
FDA grants fast track designation to Angionetics' Generx product candidate, a one-time gene therapy for coronary heart disease
7 February 2017 - Angionetics today reported that the FDA has granted fast track designation for the Phase 3 clinical investigation of Generx [Ad5FGF-4] cardiovascular angiogenic gene therapy as a one-time treatment for improving exercise tolerance in patients who have angina that is refractory to standard medical therapy and not amenable to conventional revascularisation procedures (coronary artery bypass surgery and percutaneous coronary intervention and stents).
Generx (Ad5FGF-4) is a first in class, disease altering, one-time administered, late-stage clinical product candidate initially for the treatment of patients with myocardial ischaemia and refractory angina due to coronary artery disease. Generx has been biologically engineered to enhance blood flow (perfusion) in ischaemic regions of the heart by leveraging cardiac plasticity to promote the natural formation and growth of microvascular coronary structures (collateral vessels). This is achieved by stimulating and augmenting the heart's innate natural capacity to modulate the enlargement of pre-existing collateral arterioles (arteriogenesis), and to form new capillary vessels (angiogenesis) in select ischaemic regions downstream from large coronary arteries.
