Morphotek gets protocol appro for Ph II sites

Morphotek, a US subsidiary of Japan's Eisai, has received approval of protocol by the Paul-Ehrlich-Institute, Germany's regulatory authority charged with biologics development oversight, for Phase II clinical trial site selections in Heidelberg and Frankfurt.

These sites will be used to study MORAb-003, a humanized monoclonal antibody that targets folate receptor alpha, a target over-expressed in more than 90% of ovarian cancers and a number of other solid tumors. The study will investigate the efficacy of MORAb-003 in women who are in their first relapse of ovarian cancer and allow for the recruitment of subjects in Germany to participate in the MORAb-003 Phase II trial.

Morphotek has currently enlisted 15 clinical sites in the USA to conduct its Phase II study of MORAb-003. This approval expands the ability to evaluate the efficacy of this compound in patients outside the USA.