12 week progression free rate supports advancement into second stage of Simon 2-Stage designed trial
BRANFORD, CN, USA | June 17, 2009 | CuraGen Corporation (Nasdaq: CRGN) announced today that its Phase I/II Trial evaluating CR011-vcMMAE for the treatment of patients with advanced breast cancer has met the efficacy criteria for advancement to the second stage of enrollment. To date, 29 patients have been enrolled in this trial, including 15 in the Phase II portion. Two of the first four evaluable Phase II patients were progression-free at 12 weeks, therefore, as part of the Simon 2-Stage design, the Phase II trial will now advance to the second stage and enroll a total of approximately 25 patients. The principal investigator of the study is Dr. Linda Vahdat, Medical Director of the Breast Cancer Research Program and Associate Professor of Clinical Medicine, /Weill Cornell. CuraGen anticipates presenting updated results from this study during the second half of 2009.
About CR011-vcMMAE
CR011-vcMMAE is an antibody-drug conjugate (ADC) being developed by CuraGen that consists of a fully-human monoclonal antibody, CR011, linked to a potent cell-killing drug, monomethyl-auristatin E (MMAE). The ADC technology, comprised of MMAE and a stable linker system for attaching it to CR011, was licensed from Seattle Genetics, Inc. The ADC is designed to be stable in the bloodstream. Following intravenous administration, CR011-vcMMAE targets and binds to GPNMB, a specific protein that is predominantly expressed on the surface of cancer cells, including melanoma, breast cancer and glioma. Upon internalization by the targeted cell, CR011-vcMMAE is designed to release MMAE from CR011 to produce a cell-killing effect. CR011-vcMMAE is currently in two Phase II trials assessing its safety and efficacy in the treatment of melanoma and for the treatment of metastatic breast cancer, and in a Phase I trial to evaluate the safety and activity of alternate dosing schedules.
About Breast Cancer
Breast cancer is the most common cancer in women and a leading cause of death in the United States. According to the American Cancer Society, more than 180,000 women will be diagnosed with invasive breast cancer in 2009 with more than 40,000 deaths attributed to this disease. Despite recent advances in therapy, the median survival of patients with metastatic breast cancer is 2 to 3 years, while patients with "triple-negative" or "basal-like" breast cancer have limited treatment options and poorer outcomes. Therefore, a significant unmet need remains for novel therapeutic approaches for patients with locally advanced and metastatic breast cancer who have failed other therapies.
About CuraGenCuraGen Corporation (Nasdaq: CRGN) is a clinical-stage biopharmaceutical company developing promising approaches for the treatment of cancer. CuraGen Corporation is headquartered in Branford, Connecticut. For additional information please visit http://www.curagen.com.
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12 week progression free rate supports advancement into second stage of Simon 2-Stage designed trial
BRANFORD, CN, USA | June 17, 2009 | CuraGen Corporation (Nasdaq: CRGN) announced today that its Phase I/II Trial evaluating CR011-vcMMAE for the treatment of patients with advanced breast cancer has met the efficacy criteria for advancement to the second stage of enrollment. To date, 29 patients have been enrolled in this trial, including 15 in the Phase II portion. Two of the first four evaluable Phase II patients were progression-free at 12 weeks, therefore, as part of the Simon 2-Stage design, the Phase II trial will now advance to the second stage and enroll a total of approximately 25 patients. The principal investigator of the study is Dr. Linda Vahdat, Medical Director of the Breast Cancer Research Program and Associate Professor of Clinical Medicine, /Weill Cornell. CuraGen anticipates presenting updated results from this study during the second half of 2009.
About CR011-vcMMAE
CR011-vcMMAE is an antibody-drug conjugate (ADC) being developed by CuraGen that consists of a fully-human monoclonal antibody, CR011, linked to a potent cell-killing drug, monomethyl-auristatin E (MMAE). The ADC technology, comprised of MMAE and a stable linker system for attaching it to CR011, was licensed from Seattle Genetics, Inc. The ADC is designed to be stable in the bloodstream. Following intravenous administration, CR011-vcMMAE targets and binds to GPNMB, a specific protein that is predominantly expressed on the surface of cancer cells, including melanoma, breast cancer and glioma. Upon internalization by the targeted cell, CR011-vcMMAE is designed to release MMAE from CR011 to produce a cell-killing effect. CR011-vcMMAE is currently in two Phase II trials assessing its safety and efficacy in the treatment of melanoma and for the treatment of metastatic breast cancer, and in a Phase I trial to evaluate the safety and activity of alternate dosing schedules.
About Breast Cancer
Breast cancer is the most common cancer in women and a leading cause of death in the United States. According to the American Cancer Society, more than 180,000 women will be diagnosed with invasive breast cancer in 2009 with more than 40,000 deaths attributed to this disease. Despite recent advances in therapy, the median survival of patients with metastatic breast cancer is 2 to 3 years, while patients with "triple-negative" or "basal-like" breast cancer have limited treatment options and poorer outcomes. Therefore, a significant unmet need remains for novel therapeutic approaches for patients with locally advanced and metastatic breast cancer who have failed other therapies.
About CuraGenCuraGen Corporation (Nasdaq: CRGN) is a clinical-stage biopharmaceutical company developing promising approaches for the treatment of cancer. CuraGen Corporation is headquartered in Branford, Connecticut. For additional information please visit http://www.curagen.com.
SOURCE CuraGen Corporation
Post Views: 86
