Cardiovascular Angiogenic Gene Therapy Gets Fast Track Status
Angionetics has announced that its Phase 3 clinical investigation of Generx (Ad5FGF-4) has been granted Fast Track status by the Food and Drug Administration (FDA).
The trial is intended to examine Generx 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 revascularization procedures (coronary artery bypass surgery and percutaneous coronary intervention and stents).
Generx – a first in class, late-stage clinical product candidate – was granted FDA clearance for the Phase 3 study last September. It is biologically engineered using an E1-region deleted, replication deficient adenovirus serotype 5 vector to deliver the 621 base pair gene encoding human fibroblast growth factor-4 under the control of a modified cytomegalovirus (CMV) promoter.
The Phase 3 study of Generx includes patients with refractory angina and documented clinical evidence of myocardial ischemia within the past 6 months. Enrolled patients must have clinically significant limitation of physical activity due to angina and angina-limited baseline exercise treadmill test (ETT) duration of 3-7 minutes. The primary efficacy endpoint is improvement in ETT duration at 6 months in Generx-treated patients compared to a control group. Secondary efficacy endpoints include change in CCS angina class, change in weekly angina frequency and nitroglycerin usage, and change in quality of life, assessed using the Seattle Angina Questionnaire.
For more information visit Angionetics.com.