TopoTarget initiates pivotal Phase II trial with Savicol™ for FAP (an inherited pre-disposition to develop colon cancer)

TopoTarget A/S (CSE: TOPO) 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 anti-cancer agent in the treatment of colorectal polyps in patients with FAP (Familial Adenomatous Polyposis). Savicol™ has Orphan Drug status in both the US and Europe for this indication. Results from this pivotal study are expected in the first half of 2007.

Peter Buhl Jensen, M.D. and CEO of TopoTarget 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 characterised 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 randomised, double-blind, placebo-controlled parallel group study, and the treatment schedule will run over six months. The study will be conducted at three centres in Germany and two centres in Russia and will involve a total of 60 patients.

On the basis of discussions with the European Medicines Agency (EMEA), the clinical end points for this trial include an evaluation of the polyp burden, histology/pathology of polyp biopsies, as well as the analysis of colorectal biomarkers.

The initiation of this Phase II trial with Savicol™ for FAP is in accordance with TopoTarget‘s clinical development plans.