FDA Signs Contract with Entelos to Predict Cardiovascular Adverse Events
News Dec 18, 2008
Entelos, Inc. has announced that it has entered into an agreement with the U.S. Food and Drug Administration (FDA) to use the Entelos® Cardiovascular PhysioLab® to assess the cardiovascular safety and efficacy of a specific drug class and a set of drugs within that class. The compound class and specific set of drugs were not disclosed.
The Company’s Cardiovascular PhysioLab platform is a comprehensive large-scale computer simulation of cholesterol regulation, atherogenesis, and cardiovascular risk. It has been used by Entelos for multiple pharmaceutical customers to simulate and predict the effects of drugs in patients and patient populations, evaluate novel drug targets, test combination therapies, identify and interpret biomarker patterns, and predict a drug’s long-term biological effects.
A broad range of "virtual patients" will be generated using Entelos’ cardiovascular platform and used for simulations to test the cardiovascular safety and efficacy of multiple drugs.
Results will be compared to existing clinical trial data collected by the FDA from multiple drug sponsors. Insights will help to inform the FDA on key decisions concerning the effects of novel drugs on cardiovascular disease processes.
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