TopoTargets initiates Ph II Savicol trial for FAP

Denmark's TopoTarget A/S has commenced patient treatment in a pivotal Phase II study of Savicol, a histone deacetylase (HDAC) inhibitor. The study is designed to evaluate the safety and efficacy of this oral anticancer agent in the treatment of colorectal polyps in patients with familial adenomatous polyposis (FAP). Savicol has Orphan Drug status in both the USA and Europe for this indication. Results from this pivotal study are expected in the first half of 2007.

Peter Buhl Jensen, chief executive of the company, commented: "the initiation of this pivotal study is an important milestone for TopoTarget and hopefully will prove so for FAP patients alike. FAP is a devastating disease characterized by the development of hundreds of colorectal polyps. Today, the mainstay of treatment consists of surgical removal of the colon at an early stage in life. It would be a major achievement to find a non-invasive alternative and I believe the oral formulation of Savicol would be attractive to patients. We look forward to presenting the first data from this Phase II trial in the first half of 2007."

The Phase II trial will be conducted as a randomized, double-blind, placebo-controlled parallel group study, and the treatment schedule will run over six months. It will be conducted at three centers in Germany and two in Russia and will involve a total of 60 patients.