Gene therapy for hearts gets FDA fast track
A gene therapy which could help millions of heart patients who can’t be treated by conventional methods has been given ‘fast track’ status by the FDA.
San Diego-based Angionetics is the company behind the treatment in development, Generx [Ad5FGF-4], which is part of a wave of coming gene and cell therapies which promise to revolutionise medicine.
Shares in Angionetics’ parent company Taxus Cardium shot up 22% yesterday on the news that the FDA fast tracked the treatment’s phase 3 trial.
The company estimates that there are 1.8 million patients in the US alone who have angina which is not responsive to standard medical therapy and not amenable to conventional revascularisation procedures, such as bypass surgery and percutaneous coronary intervention and stents.
Generx [Ad5FGF-4] cardiovascular angiogenic gene therapy is a one-time treatment for improving exercise tolerance in patients with refractory angina.
It uses a modified virus (replication deficient adenovirus serotype 5 vector) to deliver a growth factor (FGF-4) which stimulates new growth in the heart cells.
This augments the heart's innate ability to enlarge existing arterioles (arteriogenesis) and to form new capillary vessels (angiogenesis) to help restore normal blood flow around the body.
Generx [Ad5FGF-4] is the product of a decade’s work by at Angionetics and its predecessor companies, Collateral Therapeutics, Schering (now Bayer Healthcare) and Cardium Therapeutics.
The treatment is administered by a cardiologist into the coronary arteries under transient ischemic conditions through the use of a standard balloon catheter.
The plan is for Angionetics to be spun out as an independent company as its lead candidate advances in development.
Taxus Cardium says the Generx regulatory dossier on file with the FDA is “one of the most extensive and advanced DNA-based clinical data platforms ever compiled” which it belives positions Angionetics as the world's leader in cardiovascular angiogenic gene therapy.
