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VEGF Trap shows activity in patients with advanced ovarian cancer

Chicago, June 2, 2007 -- Preliminary results of a randomized, international Phase II trial of VEGF Trap (aflibercept) show activity in patients with recurrent epithelial ovarian cancer (EOC) who had received three or four prior chemotherapy regimens and had become resistant to platinum-based chemotherapy agents. The findings, which are being presented today at the American Society of Clinical Oncologys annual meeting, may indicate a role for this targeted therapy in women with ovarian cancer who have exhausted all other options.

To date, the trial has enrolled 162 patients with advanced ovarian cancer at 44 centers in twelve countries in Europe, Canada, and the United States. Favorable results were reported for 85 percent of participants after one month: 8 percent showed tumor shrinkage and 77 percent had stable disease. After fourteen weeks, 41 percent of patients continued to have stable disease.

The interim analysis of the Phase II data was very promising, said Dr. William P. Tew, an oncologist at Memorial Sloan-Kettering Cancer Center and the studys lead author. As a result, we are continuing to recruit patients to complete the study.

In this trial, VEGF Trap is administered intravenously as a single agent in one of two dose levels. It works by blocking the development of new blood vessels to the tumor (angiogenesis) which stops tumor growth and the spread of cancer to other parts of the body (metastasis). It can also result in tumor shrinkage. VEGF Trap is generally well-tolerated although both mild and severe side effects were reported. These included but were not limited to headache, fatigue, nausea, mild and severe hypertension, hoarseness, mild and severe protein in the urine, renal dysfunction, and a low incidence of bowel perforation (one percent).

Ovarian cancer may be unusual among solid tumors because vascular-targeting agents like VEGF Trap appear to have significant single-agent activity in advanced ovaria
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Contact: Joanne Nicholas
nicholaj@mskcc.org
917-270-3846
Memorial Sloan-Kettering Cancer Center
2-Jun-2007


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