Date: 2016-09-12
Type of information: Clinical trial autorization
phase: 3
Announcement: clinical trial authorization
Company: Angionetics (USA - CA) Huapont Life Sciences Affiliate (China)
Product: Generx® [Ad5FGF-4] gene therapy
Action
mechanism: gene therapy. 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 ischemia and refractory angina due to coronary artery disease. The Generx product candidate is biologically engineered using an E1-region deleted, adenovector serotype 5 to deliver the 621 base pair human FGF-4 DNA sequence (including the secretory signal sequence), under the control of a modified CMV promoter. The Ad5FGF-4 biologic product candidate is administered into the heart using a standard balloon catheter, intended to transfect cardiac cells which researchers believe release the FGF-4 protein, which in turn activates other growth factors and angiogenic pathways to modulate the enlargement of pre-existing collateral arterioles (arteriogenesis), and the formation of new capillary vessels (angiogenesis) in select ischemic regions downstream from large coronary arteries.
The angiogenic biological process driven by the Generx® product candidate is referred to as "medical revascularization," pioneered by researchers at Angionetics and its predecessor companies, Collateral Therapeutics, Cardium Therapeutics, and Schering AG (now Bayer Healthcare).
Disease: myocardial ischemia and refractory angina due to advanced coronary artery disease
Therapeutic area: Cardiovascular diseases
Country: USA
Trial details:
Latest
news: * On September 12, 2016, Angionetics, a majority-owned subsidiary of Taxus Cardium Pharmaceuticals Group, announced that the FDA has cleared the Angionetics' Generx® [Ad5FGF-4] angiogenic gene therapy cardiac biologic product candidate for Phase 3 clinical study as a new, single dose, treatment for patients with myocardial ischemia and refractory angina due to advanced coronary artery disease (the AFFIRM study). The Ad5FGF-4 product candidate is being developed by Angionetics as a new and innovative biologic tool for use by the interventional cardiology community.
