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FDA Approves Encysive Tests on TBC3711


Posted on 2006-12-08 09:44:00



Encysive Pharmaceuticals has been cleared by the Food and Drug Administration to resume clinical studies of TBC3711, its new endothelin receptor antagonist.

The company said it expects clinical testing of TBC3711, including oral and intravenous forms, will re-start during the first quarter of 2007. Endothelin receptor antagonists are a class of drug that block endothelin receptors, resulting in relaxation of the blood vessels, and may reduce the cellular buildup that contributes to worsening of pulmonary hypertension.

In March, Encysive's TBC3711 was about to enter early clinical studies but was placed on hold, due to an unusual finding after giving TBC3711 via IV to a single rat that had displayed abnormalities at baseline.

The delay follows a standard 30-day review process associated with Encysive's investigational new drug application for the intravenous form of TBC3711. All clinical testing of the drug, including oral and IV forms, was suspended.

Encysive develops cardiovascular drugs, including flagship Argatroban, an anticoagulant marketed by GlaxoSmithKline in the U.S. and Canada. Another drug, Thelin, could treat pulmonary arterial hypertension.


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