The Canadian drug company’s shares fell by almost 50% on the Nasdaq after the announcement of the early closing of the trail. An external monitoring committee also raised concerns over the safety of the trial, although a company steering committee rejected these fears.
“While the Steering Committee does not agree that a safety concern existed, our knowledge that the External Safety and Efficacy Monitoring Committee’s (ESEMC) analysis also considered efficacy led to our decision to recommend stopping the study at this time,” stated Dr Jeffrey Olin, professor of medicine at the Mount Sinai School of Medicine, and principal investigator. “We are now proceeding to lock the data base, fully analyze the data, and report the final results of the trial.”
The disbanded trial enrolled 553 patients with moderate to severe peripheral arterial disease (PAD) at 50 centers throughout North America. The primary endpoint of the trial was the change in maximal walking distance after six months’ treatment; a primary efficacy endpoint recognized by the FDA and other regulatory authorities for approving new treatments for symptomatic PAD.