Morphotek opens European sites for Ph II MORAb-009 study

Japanese drugmaker Eisai's US subsidiary Morphotek says that it has opened clinical sites in the European Union as part of the company's MORAb-009 Phase II study. This is evaluating MORAb-009, a monoclonal antibody to mesothelin, as a first-line treatment for patients with pancreatic cancer. The randomized, controlled, double-blinded trial will compare MORAb-009 plus gemcitabine with a placebo plus gemcitabine.

Morphotek has currently qualified 33 clinical sites in the USA and Canada to conduct its Phase II study that started earlier this year. The company has opened four clinical sites in Spain and received regulatory approval there, as well as in, Belgium and Germany and 17 sites have been qualified in these countries. Clearance for this study is also pending in Argentina. These approvals expand the ability to evaluate the efficacy of this compound in patients outside of the USA, says the company.