CuraGen Announces Initiation of Phase II Trial of CR011-vcMMAE in Patients with Advanced Breast Cancer

Wednesday, June 25, 2008 General News
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BRANFORD, Conn., June 25 CuraGen Corporation(Nasdaq: CRGN), a clinical-stage biopharmaceutical company focused ononcology, announced today the treatment of the first patient in itsCR011-vcMMAE Phase II breast cancer study.

The Phase II trial is an open-label, multi-center study of CR011-vcMMAEadministered intravenously once every three weeks to patients withlocally-advanced or metastatic breast cancer who have received prior therapy.This study will enroll up to approximately 40 patients to confirm the maximumtolerated dose (MTD) in this population and to assess efficacy using a Simon2-Stage design with an endpoint of progression-free rate at 12 weeks. Theprincipal investigator is Dr. Linda Vahdat, Medical Director of the BreastCancer 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 lookforward to better understanding how CR011-vcMMAE could be used in thetreatment of this disease," commented Dr. Timothy Shannon, President and ChiefExecutive Officer of CuraGen Corporation. "We are confident in our ability tocontinue the rapid development of this program and look forward to providingupdated CR011-vcMMAE results for the treatment of melanoma by the end of 2008and the presentation of preliminary results from this newly initiated study inbreast cancer during the first half of 2009."

CR011-vcMMAE targets a protein known as glycoprotein NMB (GPNMB), which isoverexpressed in a variety of cancers including breast cancer, melanoma, andbrain tumors. CR011-vcMMAE is an antibody-drug conjugate comprised of afully-human monoclonal antibody against GPNMB linked to a potent tubulinstabilizing agent, monomethyl auristatin E (MMAE). The enzyme-sensitivelinker, which was licensed from Seattle Genetics, is designed to be stable inthe bloodstream and to release MMAE inside tumor cells, resulting in cancercell death.

Dr. Ronit Simantov, Vice President and Chief Medical Officer commented,"Preclinical studies have shown that GPNMB is expressed in aggressive breastcancers and is believed to play a role in promoting invasion and metastasis ofbreast cancer cells. Furthermore, conjugating an antibody against thisbiologically relevant target with MMAE, a cytotoxic drug that belongs to aclass of therapeutics known to be active against breast cancer, represents anovel approach to treating this disease."

Objective responses have been observed in patients with advanced melanomatreated with CR011-vcMMAE. A Phase II study of CR011-vcMMAE in patients withmelanoma is currently enrolling patients, and preclinical studies withCR011-vcMMAE for the treatment of gliomas are ongoing.

About Breast Cancer

Breast cancer is the most common cancer in women and a leading cause ofdeath in the United States. According to the American Cancer Society, morethan 180,000 women will be diagnosed with invasive breast cancer in 2008 withmore than 40,000 deaths attributed to this disease. Despite recent advancesin therapy, the median survival of patients with metastatic breast cancer is 2to 3 years, while patients with "triple-negative" or "basal-like" breastcancer have limited treatment options and poorer outcomes. Therefore, asignificant unmet need remains for novel therapeutic approaches for patientswith locally advanced and metastatic breast cancer who have failed othertherapies.

About CuraGen

CuraGen Corporation (Nasdaq: CRGN) is a dedicated clinical-stagebiopharmaceutical company developing diverse approaches for the treatment ofcancer. CuraGen Corporation is headquartered in Branford, Connecticut. Foradditional information please visit

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