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news.Shares in Corautus Genetics plunged over 60% after the company halted enrollment in a phase IIb trial evaluating its treatment for severe angina, after a data monitoring board said that the poor risk to benefit profile of the drug made it futile to continue.
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Based on available efficacy data, the independent data monitoring board said that enrollment should be terminated under the current protocol as it saw “very little chance for significant efficacy as to the primary endpoint relative to the safety risk”.
The company will continue to collect efficacy data until the last patient previously enrolled in the trial has been followed for six months. At that time, the company plans to lock the study database and perform unblinded endpoint analyses of VEGF-2 efficacy.
Safety data will be followed for a period of 12 months from the date the last patient was enrolled.
Corautus voluntarily suspended enrollment in the trial in March to fully investigate three serious adverse events that the company believes were not associated with the drug.
At that time, 295 patients had been enrolled in the trial, which was originally scheduled to enroll 404 patients. In response to the company’s action, the FDA placed the trial on clinical hold.
“We enrolled a large patient population in this trial, and we believe the data that will be generated from the trial will be sufficiently robust to allow us to draw conclusions. The ultimate story on GENASIS (the trial) will not be known until all the data is received and fully analyzed,” said Richard Otto, president and chief executive officer of Corautus.