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12:00 AM
Nov 12, 2007
 |  BioCentury  |  Product Development

Changing horses midstream

In 2005, based on discussions with FDA, Gentium S.p.A. designed a Phase III trial of defibrotide to treat veno-occlusive disease with overall survival as the primary endpoint. Last week, the company said it plans to submit a protocol amendment to change the endpoint of the ongoing trial to complete response rate - again based on advice from the agency.

According to GENT, FDA believes this endpoint will make it easier to discern a treatment effect in VOD, because survival can be skewed by patients succumbing to any number of other complications.

GENT (Villa Guardia, Italy) received Italian marketing approval for injectable defibrotide in 1986 to treat deep vein thrombosis (DVT) and to prevent and treat vascular diseases with risk of thrombosis. An oral formulation was approved in 1992.

More recently, GENT has set its sights on developing defibrotide for VOD, which is characterized by a blockage of the small veins of the liver and may result...

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