Regado Halts Big Heart Drug Trial, Shares Hammered
Summary
But the Basking Ridge, NJ-based company suffered a setback Wednesday when it was forced to suspend the trial pending a review of potential safety problems.Regado (NASDAQ: RGDO) said that the data safety monitoring board overseeing the study of its anticoagulant, REG1 (now known as Revolixys Kit), has started an “unplanned review” of the trial.The board will conduct a full analysis of the “safety and treatment benefit-risk ratio” of all the 3,234 patients who have been enrolled in the study so far, focusing on serious adverse events due to allergic reactions to REG1.Regado’s big plan is to try to prove that REG1 is better at preventing strokes and other so-called ischemic events in patients undergoing an angioplasty than The Medicines Co.’s (NASDAQ: MDCO) bivalirudin (Angiomax).To test its system, Regado gambled: it chose to run a 13,200-patient study in 500 sites around the world, a job that Big Pharma, and all its financial wherewithal and manpower, is best suited for.
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