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Celldex Therapeutics Initiates METRIC, An Accelerated Approval Study Of Glembatumumab Vedotin In Patients With Triple Negative Breast Cancer

HAMPTON, N.J., Dec. 2, 2013 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (Nasdaq:CLDX) today announced that it has launched a randomized study (METRIC) of Glembatumumab vedotin (CDX-011) in patients with metastatic triple negative breast cancers that over-express glycoprotein NMB (gpNMB). Glembatumumab vedotin is an antibody-drug conjugate that targets and binds to gpNMB, a specific protein that is expressed in breast cancer which promotes the migration, invasion and metastasis of the disease. It is also highly expressed in triple negative breast cancers where it is associated with increased risk of recurrence. Initial sites are now open to screen patients in the United States. Additional sites in the United States and in Canada and Australia will open in early 2014. The study is expected to include up to 100 sites and will enroll approximately 300 patients.

"In the Phase 2 EMERGE study, Glembatumumab vedotin elicited impressive response rates that correlated with a survival benefit for patients with metastatic breast cancer that also had high levels of gpNMB on the surface of their tumor cells," said Thomas Davis, M.D., Senior Vice President and Chief Medical Officer of Celldex. "Currently, patients with triple negative breast cancer have very limited treatment options and no targeted interventions. We believe gpNMB could be an important marker in breast cancer and that Glembatumumab vedotin holds significant potential as a possible targeted therapy for women facing this disease."

"Given the lack of treatment options available for women with triple negative breast cancer, we are gratified that we are able to conduct the METRIC study on an accelerated approval path and are committed to enrolling the study expeditiously," said Anthony Marucci, President and Chief Executive Officer of Celldex. "We also plan to further expand the clinical development program for Glembatumumab vedotin in 2014 by initiating additional studies in other cancers known to express gpNMB including melanoma and squamous cell lung cancer."

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