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news.Corautus Genetics has filed a response to the FDA clinical hold on its 'Genasis' trial which was imposed due to potential safety concerns with the delivery of the company's product candidate for the treatment of severe angina.
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The company voluntarily suspended the trial on March 14th 2006 after three serious cases of pericardial effusion – a condition characterized by an accumulation of fluid around the heart.
Since the trial was put on hold, Corautus has been working with Boston Scientific Corporation, which developed the delivery system being used in the trial, in order to investigate the adverse events. The company has now submitted the results of this investigation to the FDA.
“We look forward to analyzing the data and continuing discussions with the FDA to determine an appropriate primary endpoint in a trial for the treatment of patients suffering from severe angina. We continue to be hopeful the information generated by our analysis may support the commencement of a Phase III clinical trial,” said Richard Otto, president and CEO of Corautus.