The FDA notified the clinical stage biopharmaceutical company that it has satisfactorily addressed the majority of the issues raised in the March 29, 2006 clinical hold letter and that the clinical hold on the Genasis phase IIb clinical trial for the treatment of the cardiovascular disease has now been lifted.
Corautus says it now plans to lock the Genasis clinical trial database and conduct analyses of the data for efficacy endpoints and safety information.
The investigational new drug application (IND) will remain on a “partial hold,” as Corautus expected, until the remaining issues in the letter, all of which are associated with results of certain tests related to the delivery catheter system and injection procedure, are completed. Corautus expects to submit the results of those tests and the efficacy and safety analyses from the Genasis clinical trial to the FDA for review later this year.
Corautus ceased enrolling patients in the Genasis trial on March 14, 2006, but it has continued to gather follow-up data on treated patients. Corautus will lock the database on August 14, 2006 for the 295 patients treated in the Genasis clinical trial. The efficacy and safety analyses to be performed on the database will include 295 patients at 3 months, 241 patients at 6 months and 103 patients at 12 months. Corautus expects to present the results from the trial in the fall of 2006.
“We are pleased with the FDA’s decision to lift the clinical hold on the Genasis trial, and we will work with personnel from Boston Scientific Corporation to complete the additional testing requested by the FDA. We continue to have active dialogue with the FDA regarding our development plans,” said Richard Otto, president and CEO of Corautus.