CuraGen initiates Phase II breast cancer study

The Phase II trial is an open-label, multi-center study of CR011-vcMMAE administered intravenously once every three weeks to patients with locally-advanced or metastatic breast cancer who have received prior therapy. This study will enroll up to approximately 40 patients to confirm the maximum tolerated dose (MTD) in this population and to assess efficacy using a Simon 2-Stage design with an endpoint of progression-free rate at 12 weeks.

CR011-vcMMAE targets a protein known as glycoprotein NMB (GPNMB), which is overexpressed in a variety of cancers including breast cancer, melanoma, and brain tumors. CR011-vcMMAE is an antibody-drug conjugate comprised of a fully-human monoclonal antibody against GPNMB linked to a potent tubulin stabilizing agent, monomethyl auristatin E (MMAE). The enzyme-sensitive linker, which was licensed from Seattle Genetics, is designed to be stable in the bloodstream and to release MMAE inside tumor cells, resulting in cancer cell death.

Timothy Shannon, president and CEO of CuraGen, said: “We are confident in our ability to continue the rapid development of this program and look forward to providing updated CR011-vcMMAE results for the treatment of melanoma by the end of 2008 and the presentation of preliminary results from this newly initiated study in breast cancer during the first half of 2009.”