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BTG TO COMMENCE US PHASE II CLINICAL SAFETY STUDY OF VARISOLVE
BTG plc, the medical innovations company, today announces that it intends to complete preparations for and commence a US phase II clinical safety study of Varisolve, the novel injectable microfoam treatment for varicose veins. BTG's preferred strategy had been to partner the programme prior to commencing a US phase II safety study. The Company now intends to move forward with the study, which it is able to fund from existing resources without impacting current development activities in the broader BTG pipeline, in order to maintain development progress and to continue to build value in the product whilst continuing partnering discussions. Louise Makin, BTG's chief executive officer, commented: “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, recognising that some potential partners may first want to see positive data emerging from the study.” The phase II study will explore the safety of Varisolve in 50 patients who have a patent foramen ovale, a defect whereby the small hole that connects the right and left atria of the heart to improve foetal circulation does not close at birth. PFOs are estimated to be present in approximately 20% of the population. Under certain conditions, they 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.
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