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.Pharmaceutical and medical technology company BTG is to commence a US phase II clinical safety study of Varisolve, the company's novel injectable microfoam treatment for varicose veins.
Subscribe to our email newsletter
The phase II study will explore the safety of Varisolve in 50 patients who have a patent foramen ovale (PFO), a defect estimated to be present in approximately 20% of the population, whereby the small hole that connects the right and left atria of the heart to improve fetal circulation does not close at birth.
Under certain conditions, PFOs allow blood (and potentially clots, particles or bubbles within the blood) to travel from the right atrium into the left atrium, then out of the heart and into the arterial system.
The study aims to answer the US regulator’s question as to whether the microbubbles in Varisolve that cross through the PFO can cause sub-clinical effects in the brain such as microinfarcts.
Varisolve has successfully completed a pivotal European phase III trial in which 435 patients were treated with the product and followed up for one year.
“We have decided to progress this study so that we can maintain momentum and generate important safety data on Varisolve. We will in parallel continue to pursue all partnering options for Varisolve, recognizing that some potential partners may first want to see positive data emerging from the study,” said Louise Makin, BTG’s CEO.