Regado plummets on Phase III trial halt
Regado Biosciences Inc. (NASDAQ:RGDO) fell $1.71 (60%) to $1.13 on Monday after it said an independent DSMB indicated the level of serious allergic adverse events associated with Revolixys Kit was "of a frequency and severity such that they recommended" against enrolling further patients in the Phase III REGULATE-PCI trial to treat acute coronary syndrome (ACS). Regado initially halted enrollment last month after the DSMB initiated an unplanned review due to potential allergic reactions. The trial had enrolled 3,250 of a planned 13,200 patients undergoing percutaneous coronary intervention (PCI) (see BioCentury Extra, July 3).
On a conference call to discuss the news, CEO David Mazzo said Regado will conduct an internal review of the data to determine the cause of the allergic reactions. He said the results will be submitted to the FDA but declined to disclose future plans for Revolixys. The product is composed of IV pegnivacogin ( RB006), a pegylated, single-stranded RNA aptamer that binds to Factor IXa, and IV anivamersen ( RB007), a complementary single-stranded RNA containing a 15-nucleotide sequence that binds to and neutralizes pegnivacogin. ...