Gentium's Defibrotide in multiple trials for vascular disease, cancer

By Lisa Kerner

Erie, Pa., Feb. 2 - Gentium SpA said that Defibrotide, an endothelium stabilizing drug, has anti-angiogenic properties in vitro and in vivo. Defibrotide is a single-stranded DNA that protects the vascular endothelial cells from damage and activation, according to a company news release.

Defibrotide was tested in vitro using the sprouting of cells from the rat aortic ring in Matrigel and a kit with human microvascular endothelial cells (AngioKit). The in vivo testing was performed in mice injected with human gastric cancer, the company said.

The results indicated that daily application of Defibrotide blocks sprouting in the aortic ring assay. The second in vitro assay demonstrates that Defibrotide reduces vessel formation of human microvascular endothelial cells across a barrier of dermal fibroblasts.

"Our data suggest that while Defibrotide is known for its endothelium-protecting function, it also inhibits tumor blood vessel formation and thus should be considered for further testing as an anti-cancer agent, either alone or in combination with other drugs," Guenther Eisser, chief of biology research for Gentium, said in the release.

Gentium said it is awaiting Institutional Review Board approval for its pivotal U.S. phase 3 trial of Defibrotide to treat severe VOD, a blockage of the small veins of the liver, resulting in liver and other organ failure.

The company also began a phase 2/3 trial with Defibrotide to prevent VOD in pediatric patients. The randomized study will include 270 pediatric patients at 30 clinical sites in Europe and Israel. A similar study in adult patients is slated for the second quarter of 2006 in Europe and in the United States by 2007.

Defibrotide is also the subject of an independent phase 1/2 study to treat multiple myeloma in combination with Melphalan, Prednisone and Thalidomide currently underway at 10 centers in Italy.

Gentium is a biopharmaceutical company located in Villa Guardia, Italy.

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