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news.BTG, a life sciences company, has completed the enrollment and treatment of patients in the US Phase II safety study of Varisolve polidocanol endovenous microfoam, which is under development as a treatment for varicose veins.
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A total of 82 patients with saphenous vein incompetence were treated with Varisolve, of whom 57 patients met the study requirement of having bubbles detected in the cerebral circulation during treatment. In line with the trial protocol, all 57 of these patients have had MRI brain scans 24 hours after treatment; 40 of these patients have also completed the required 28-day MRI scans with the remainder expected to complete their 28 day MRI scans by the end of June 2008.
The study was conducted to investigate whether there was any evidence of subclinical effects in 50 patients with such shunts (more were treated to allow for possible late patient withdrawals from the study) following treatment with Varisolve. To date, no MRI lesions, neurological abnormalities or elevated cardiac markers have been found as a result of the treatment in any of the patients.
Louise Makin, BTG’s CEO, said: “We are delighted that we have found no evidence of subclinical effects in any patients following treatment with Varisolve in this study. This supports our objective of developing Varisolve for the widest possible patient base by enabling recruitment to the planned Phase III trials without having to screen future patients for cardiac shunts.”