Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Corautus Genetics has published the two-year follow-up results of its earlier phase I study of patients with severe angina, revealing that its gene therapy treatment demonstrated prolonged clinical benefit.
Subscribe to our email newsletter
In this trial, vascular endothelial growth factor-2 (VEGF-2) in the form of ‘naked’ plasmid DNA was delivered in defined doses by direct injection into the heart muscle. Results of the follow-up study demonstrate prolonged clinical benefit as measured by improvement of patients’ angina two years following treatment with no reported complications directly related to the gene therapy procedure.
Corautus’ technology is currently being tested in a randomized, double- blinded, dose-ranging and placebo-controlled phase IIb clinical trial known as GENASIS, which will enroll 404 patients with class III or IV angina that are not suitable candidates for traditional revascularization procedures.
The GENASIS trial will be conducted in approximately 25 cardiac medical centers throughout the US and Corautus expects to complete patient enrollment around the end of 2005.
“While previous findings showed positive results, the two-year follow-up of the phase I data demonstrate that VEGF-2 therapy may be associated with prolonged clinical benefit in patients who have no other options for the treatment of severe angina,” commented Dr Douglas Losordo, the national principal investigator for the GENASIS trial and chief of cardiovascular research at Caritas St Elizabeth’s Medical Center in Boston.
“These results are cause for encouragement, and we are now conducting the largest double-blinded, placebo-controlled trial of its kind to confirm these findings.”