CancerVax's IND for cancer antibody D93 approved by FDA

By Angela McDaniels

Seattle, April 3 - CancerVax Corp. said the Food and Drug Administration has approved the company's Investigational New Drug application for D93, an investigational, humanized, monoclonal antibody that inhibits tumor growth and angiogenesis, the formation of new blood vessels that feed tumors.

The company plans to begin a phase 1 clinical trial to evaluate the safety and tolerability of D93 in the treatment of patients with solid tumors later in 2006, according to a news release.

CancerVax said D93's mechanism of action differs from other angiogenesis inhibitors that are being evaluated in clinical trials or that have been approved by the FDA; it selectively binds to targets in the extracellular matrix, a molecular network that provides structural support to tissues and regulates cellular processes. These targets are exposed during tumor formation, when the collagen making up the extracellular matrix is denatured by tumor cells.

In preclinical studies, D93 has been shown to preferentially bind to denatured collagen in melanoma and colon, lung and breast tumors; to inhibit tumor growth in pancreatic and melanoma tumor models; and, by fluorescent antibody techniques, to bind preferentially to the extracellular matrix around blood vessels in tumor sections taken from patients instead of healthy tissues adjacent to the tumor, according to the release.

Administering D93 with Taxol (paclitaxel) has also been demonstrated to inhibit tumor growth in animal models of human breast cancer better than either treatment alone, the company added.

CancerVax is a biotechnology company based in Carlsbad, Calif., that researches, develops and commercializes biological products for the treatment of cancer.

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