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news.After reviewing CancerVax Corporation's investigational new drug application, the FDA has given its approval for the company to begin human testing of D93, an anti-cancer monoclonal antibody with a novel anti-angiogenic and tumor inhibitory mechanism of action.
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Preclinical studies with D93 have demonstrated its ability to reduce angiogenesis and inhibit tumor growth in in vivo models of several types of cancer. CancerVax plans to initiate a phase I clinical trial to evaluate the safety and tolerability of D93 in the treatment of patients with solid tumors later in 2006.
“Obtaining the FDA’s approval of our investigational new drug application for D93 is another important step in advancing the development program for our novel drug candidate for solid tumors,” said David Hale, president and CEO of CancerVax Corporation.
D93 is a humanized, monoclonal antibody that inhibits tumor growth and angiogenesis, the formation of new blood vessels that feed rapidly growing tumors. Its mechanism of action differs from other angiogenesis inhibitors that are being evaluated in clinical trials or that have been approved by the FDA, such as Avastin (bevacizumab).
D93 selectively binds to targets in the extracellular matrix, a molecular network that provides structural support to tissues and regulates cellular processes such as adhesion, migration and cell growth. These targets are exposed during tumor formation, when the collagen comprising the extracellular matrix is denatured or remodeled by tumor cells.