CuraGen Corp. (CRGN), a clinical-stage biopharmaceutical company focused on oncology, on Wednesday announced it has begun Phase II trial of CR011-vcMMAE in the treatment of breast cancer.
CR011-vcMMAE targets a protein known as glycoprotein NMB, or GPNMB, which is overexpressed in a variety of cancers including breast cancer, melanoma and brain tumors.
During the Phase II trial, CR011-vcMMAE will be administered intravenously once every three weeks to patients with locally advanced or metastatic breast cancer who have received prior therapy, the company noted. The study would enroll up to 40 patients to confirm the maximum tolerated dose and to assess efficacy using a Simon 2-Stage design with an endpoint of progression-free rate at 12 weeks.
CR011-vcMMAE is an antibody-drug conjugate comprised of a fully-human monoclonal antibody against GPNMB linked to a tubulin stabilizing agent, monomethyl auristatin E. The enzyme-sensitive linker, designed to be stable in the bloodstream, releases MMAE inside tumor cells, resulting in the death of cancer cell.
The Branford, Connecticut headquartered company said that CR011-vcMMAE has produced objective responses in patients with advanced melanoma and preclinical studies with the medicine for the treatment of gliomas are ongoing.
President and chief executive officer Timothy Shannon said, "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."
According to the American Cancer Society, more than 180,000 women will be diagnosed with invasive breast cancer in 2008 resulting in more than 40,000 deaths. Despite the advances in therapy, the median survival of patients with metastatic breast cancer has been 2 to 3 years.
CRGN closed Tuesday's regular trade on Nasdaq at $0.93.
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