Thursday, Oct 25, 2001
South San Francisco, Calif. -- October 25, 2001 --Genentech, Inc. (NYSE: DNA) today announced that the National Cancer Institute (NCI), Surgery Branch, has stopped recruitment to its Phase II trial in metastatic renal cell carcinoma (kidney cancer) using Genentech's angiogenesis inhibitor, Avastin™ (Bevacizumab), a humanized antibody to vascular endothelial growth factor (VEGF). Recruitment to this randomized, double-blind, placebo-controlled trial was stopped based on the recommendation of the National Cancer Institute/Center for Cancer Research's Data and Safety Monitoring Board (DSMB), which determined that the trial had reached its pre-specified efficacy endpoint at the second interim analysis.
"We are encouraged by this further confirmation of Avastin's anti-angiogenic activity," said Susan D. Hellmann, MD, MPH, Genentech's executive vice president, Development and Product Operations, and chief medical officer. "In conjunction with our Phase II data in colorectal and breast cancer, these results provide a proof of the concept for blocking angiogenesis in cancer. It will now be important to confirm that this activity is associated with clinical benefit for patients in larger definitive trials."
At Genentech's request, an independent review board will be convened to further analyze and review the data and help determine the significance of the results.
"We will work closely with the NCI and the U.S. Food and Drug Administration (FDA) to determine next steps based on this independent review," added Gwen Fyfe, MD, Genentech's senior director of Oncology, Medical Affairs.
Jim Yang, MD, of the NCI's Surgery Branch and principal investigator of the trial will present preliminary information from this study at the Second International Kidney Cancer Symposium on October 27, 2001 in Chicago, Illinois.
Genentech, Inc. is a leading biotechnology company that discovers, develops, manufactures, and markets human pharmaceuticals for significant unmet medical needs. Fifteen of the currently approved biotechnology products stem from or are based on Genentech science. Genentech manufactures and markets ten biotechnology products directly in the United States. The company has headquarters in South San Francisco, California, and is traded on the New York Stock Exchange under the symbol DNA.
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