http://www.medicalnewstoday.com/articles/112768.php
CuraGen Announces Initiation Of Phase II Trial Of CR011-vcMMAE In Patients With Advanced Breast Cancer
CuraGen Corporation (Nasdaq: CRGN), a clinical-stage biopharmaceutical company focused on oncology, announced today the treatment of the first patient in its CR011-vcMMAE 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. The principal investigator is Dr. Linda Vahdat, Medical Director of the Breast Cancer Research Program and Associate Professor of Clinical Medicine, NewYork-Presbyterian Hospital/Weill Cornell.
"We believe that GPNMB is a promising target in breast cancer, and we look forward to better understanding how CR011-vcMMAE could be used in the treatment of this disease," commented Dr. Timothy Shannon, President and Chief Executive Officer of CuraGen Corporation. "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."
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.
Dr. Ronit Simantov, Vice President and Chief Medical Officer commented, "Preclinical studies have shown that GPNMB is expressed in aggressive breast cancers and is believed to play a role in promoting invasion and metastasis of breast cancer cells. Furthermore, conjugating an antibody against this biologically relevant target with MMAE, a cytotoxic drug that belongs to a class of therapeutics known to be active against breast cancer, represents a novel approach to treating this disease."
Objective responses have been observed in patients with advanced melanoma treated with CR011-vcMMAE. A Phase II study of CR011-vcMMAE in patients with melanoma is currently enrolling patients, and preclinical studies with CR011-vcMMAE for the treatment of gliomas are ongoing.
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