Credit: Andre E.X. Brown
Regado Biosciences, Inc., has permanently terminated enrollment in the phase 3 REGULATE-PCI trial due to serious allergic reactions in patients treated with the Revolixys Kit (also known as REG-1).
The kit is a 2-component system consisting of pegnivacogin, an anticoagulant aptamer specifically targeting coagulation factor IXa, and its complementary oligonucleotide active control agent, anivamersen.
The REGULATE-PCI trial is a comparison of the Revolixys Kit and bivilarudin in patients undergoing percutaneous coronary intervention.
A data and safety monitoring board analyzed data from the roughly 3250 patients initially enrolled in the trial and discovered serious allergic reactions in patients treated with Revolixys.
“The [board] indicated that the level of serious allergic adverse events associated with Revolixys was of a frequency and severity such that they recommended that we do not enroll any further patients in the REGULATE-PCI trial,” said David J. Mazzo, PhD, CEO of Regado.
“We will now undertake a complete review of the unblinded database from REGULATE-PCI, which we expect will take several months to complete.”
Dr Mazzo did not provide details as to the type of allergic reactions patients experienced or the incidence of these events. He did say the exact cause of the reactions is unknown, but the data review and investigation should reveal that information.
The review should also provide information that will help Regado decide how to move forward with its development of Revolixys (REG-1) and a related system known as REG-2.
For more information on REG-1 and REG-2, visit Regado’s website. For more information on REGULATE-PCI, visit clinicaltrials.gov.
