FDAnews
www.fdanews.com/articles/85842-gloucester-reports-preclinical-data-from-depsipeptide-study

GLOUCESTER REPORTS PRECLINICAL DATA FROM DEPSIPEPTIDE STUDY

April 5, 2006

Gloucester Pharmaceuticals has reported preclinical research suggesting the potential of the company's lead product candidate, depsipeptide (FK228), in combination with gemcitabine, as a treatment for pancreatic adenocarcinoma.

In the current study, the antitumor activity of depsipeptide was tested -- as a single agent and in combination with gemcitabine - in two murine tumor models of pancreatic adenocarcinoma, a mutant ras model (PANC-1) and a wild-type ras model (BxPC-3). Significant activity of the combination of depsipeptide and gemcitabine was observed in the mutant ras PANC-1 model, with marked inhibition of tumor growth and partial tumor regressions, as compared to gemcitabine alone. In addition, the tumor responses were maintained well beyond the last drug administration. Any toxicities observed were mild and reversible following cessation of dosing.