BTG progresses Varisolve development

UK drug developer BTG reported positive interim data from a US Phase II safety study of its Varisolve (polidocanol), a foam-injection treatment for varicose veins, at the March annual meeting of the Society of Interventional Radiologists. The trial found no new magentic resonance imaging lesions, neurological or other visual field abnormalities or elevated cardiac markers being observed in the first 28 of the required 50 patients with bubbles detected in the middle cerebral artery following treatment with Varisolve. The study continues to progress well, the firm noted.

The structure of the overall Phase III program and the pivotal Phase III study designs have been agreed with the US Food and Drug Adminsitration. To validate aspects of the study protocols and to enable a Special Protocol Assessment to be sought later in 2008, BTG plans to conduct a Phase III pilot study and other key Phase III activities over the coming six months.

Significant progress has also been made with the product's design and manufacturing. A smaller, lower-cost, user-friendly single-canister presentation has now replaced the bulkier two-can product. Manufacturing has been contracted to a third party, and the new process and pilot plant have been fully validated, BTG added.