Morphotek Expands Phase II Cancer Trial Site Selections in EU
Morphotek, a subsidiary of Eisai Corporation of North America, has opened clinical sites in the EU as part of the company’s MORAb-009 Phase II study.
The Phase II study 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 US and Canada to conduct its Phase II study that started earlier in 2008. The company has opened four clinical sites in Spain and received regulatory approval in Spain, Belgium and Germany and 17 sites have been qualified in these countries.
Regulatory approval 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 US.
Martin Phillips, chief medical officer of Morphotek, said: “We are extremely pleased to receive approval for the MORAb-009 Phase II trial sites in the EU. We look forward to the possible involvement of additional European clinical sites for this compound as well as others in our pipeline.”