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CuraGen Announces Expansion of CR011-vcMMAE Phase II Trial in Melanoma
Date:6/11/2008

valuating CR011- vcMMAE in patients with advanced melanoma utilizes a Simon 2-Stage design with a primary endpoint of objective response rate. Patients enrolled in the study may have received no more than one prior cytotoxic regimen, but may have received an unlimited number of prior cytokine, immune or vaccine therapies. Enrollment in the study is expected to be completed by the end of 2008.

CR011-vcMMAE targets a protein known as GPNMB, which has been shown to be overexpressed in melanoma, breast cancer and brain tumors. Based on the clinical activity observed in the treatment of melanoma, CuraGen anticipates initiating a Phase II trial evaluating CR011-vcMMAE for the treatment of patients with metastatic breast cancer in the third quarter of 2008. Furthermore, CuraGen is conducting preclinical research to determine the optimal approach for utilizing CR011-vcMMAE as a potential treatment of brain tumors, including glioblastoma multiforme.

CR011-vcMMAE is an antibody-drug conjugate (ADC) comprised of a fully- human monoclonal antibody against glycoprotein NMB (GPNMB) attached to a potent, synthetic drug monomethyl auristatin E (MMAE), using Seattle Genetics' proprietary technology. GPNMB is a novel, selective target that plays a role in the ability of cancer cells to invade and metastasize. CR011-vcMMAE contains an enzyme-cleavable linker designed to be stable in the bloodstream and to release MMAE after internalization into tumor cells that express GPNMB, resulting in cancer cell death.

About Melanoma

The number of people diagnosed with melanoma is rapidly increasing. It is expected that approximately 60,000 new cases of melanoma will be diagnosed and an estimated 8,000 people in the U.S. will die of the disease during 2008. The prognosis for patients with advanced melanoma is poor, and studies have shown that the median survival is less than nine months.

About CuraGen

CuraGen Corporation (Nasdaq:

SOURCE CuraGen Corporation
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