Additional Findings from RADAR Trial Published in Journal of Invasive Cardiology
BASKING RIDGE, NJ, USA I January 29, 2014 I Regado Biosciences, Inc. (RGDO), a biopharmaceutical company focused on the late-stage clinical development of its first-in-class, actively controllable antithrombotic drug system, REG1, today announced the publication of additional findings from its completed Phase 2b RADAR trial in the Journal of Invasive Cardiology1 demonstrating the safety of early sheath removal in patients treated with REG1.
The analysis showed that REG1 allowed for very early arterial sheath removal following cardiac catheterization without increasing the time to hemostasis or the frequency of vascular access-site bleeding complications. The study further determined that patients anticoagulated with REG1 during cardiac catheterization had their arterial sheath removed an average of more than three hours earlier than those anticoagulated with unfractionated heparin (UFH).
“These findings further support our belief that the REG1 Anticoagulation System may possess many advantages over currently available anticoagulants by providing a high level of anticoagulation that is controllable and fully reversible,” said David J. Mazzo, Ph.D., chief executive officer of Regado Biosciences. “While further studies are needed to determine whether anticoagulation with REG1 and early sheath removal following cardiac catheterization will translate into improved time to ambulation, shorter hospital stays and reduced costs for certain patients, we are very pleased to report these findings, which support REG1’s remarkable safety and its broad potential impact for cardiologists, patients and payors.”
The publication, titled “Safety of Very Early Sheath Removal in Patients Treated With REG1 for Acute Coronary Syndromes: Insights From the RADAR Trial,” examined arterial sheath management outcomes and vascular access complications in patients who had sheath removal without vascular closure device implantation, comparing the patients anticoagulated with REG1 versus UFH. Results from the study demonstrated that despite near-immediate sheath removal following cardiac catheterization, the time of manual staff intervention required to achieve homeostasis and the number of major vascular access bleeding complications did not increase. Patients treated with REG1 were also found to have experienced numerically fewer major access-site bleeding complications than those anticoagulated with UFH.
Regado is currently testing REG1 in a global Phase 3 clinical trial, REGULATE-PCI, which is designed to show superiority in efficacy and non-inferiority in safety against the current standard, bivalirudin. The first of three key interim analyses in the trial will occur after enrollment of the first 1,000 patients, which is expected to occur during the second quarter of 2014.
ABOUT REGADO BIOSCIENCES
Regado Biosciences, Inc., is a biopharmaceutical company focused on the development of novel, first-in-class, actively controllable antithrombotic drug systems for acute and sub-acute cardiovascular indications. Regado is pioneering the development of two-component drug systems consisting of a therapeutic aptamer and its specific active control agent. The company’s lead product candidate, REG1, is a two-component system consisting of pegnivacogin, an anticoagulant aptamer specifically targeting coagulation Factor IXa, and its complementary oligonucleotide active control agent, anivamersen. REG1 is currently being evaluated in the REGULATE-PCI trial, a worldwide Phase 3 study enrolling 13,200 patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI), a hospital-based procedure used to mechanically open or widen obstructed coronary arteries. Regado’s actively controllable product candidates have the potential to improve patient outcomes, enhance the patient experience and reduce overall treatment costs. More information can be found at www.regadobio.com.
For more information on REGULATE-PCI, please visit:
http://www.clinicaltrials.gov/ct2/show/NCT01848106
1Vavalle JP, Povsic TJ, Aberle LH, Zelenkofske SL, Mehran R, Kasprzak JD, Bode C, Buller CE, Montalescot G, Cornel JH, Becker RC, Alexander JH, Cohen MG. Safety of Very Early Sheath Removal in Patients Treated With REG1 for Acute Coronary Syndromes: Insights From the RADAR Trial. J Invasive Cardiol. 2013 Nov;25(11):593-9.
SOURCE: Regado Biosciences
Post Views: 674
Additional Findings from RADAR Trial Published in Journal of Invasive Cardiology
BASKING RIDGE, NJ, USA I January 29, 2014 I Regado Biosciences, Inc. (RGDO), a biopharmaceutical company focused on the late-stage clinical development of its first-in-class, actively controllable antithrombotic drug system, REG1, today announced the publication of additional findings from its completed Phase 2b RADAR trial in the Journal of Invasive Cardiology1 demonstrating the safety of early sheath removal in patients treated with REG1.
The analysis showed that REG1 allowed for very early arterial sheath removal following cardiac catheterization without increasing the time to hemostasis or the frequency of vascular access-site bleeding complications. The study further determined that patients anticoagulated with REG1 during cardiac catheterization had their arterial sheath removed an average of more than three hours earlier than those anticoagulated with unfractionated heparin (UFH).
“These findings further support our belief that the REG1 Anticoagulation System may possess many advantages over currently available anticoagulants by providing a high level of anticoagulation that is controllable and fully reversible,” said David J. Mazzo, Ph.D., chief executive officer of Regado Biosciences. “While further studies are needed to determine whether anticoagulation with REG1 and early sheath removal following cardiac catheterization will translate into improved time to ambulation, shorter hospital stays and reduced costs for certain patients, we are very pleased to report these findings, which support REG1’s remarkable safety and its broad potential impact for cardiologists, patients and payors.”
The publication, titled “Safety of Very Early Sheath Removal in Patients Treated With REG1 for Acute Coronary Syndromes: Insights From the RADAR Trial,” examined arterial sheath management outcomes and vascular access complications in patients who had sheath removal without vascular closure device implantation, comparing the patients anticoagulated with REG1 versus UFH. Results from the study demonstrated that despite near-immediate sheath removal following cardiac catheterization, the time of manual staff intervention required to achieve homeostasis and the number of major vascular access bleeding complications did not increase. Patients treated with REG1 were also found to have experienced numerically fewer major access-site bleeding complications than those anticoagulated with UFH.
Regado is currently testing REG1 in a global Phase 3 clinical trial, REGULATE-PCI, which is designed to show superiority in efficacy and non-inferiority in safety against the current standard, bivalirudin. The first of three key interim analyses in the trial will occur after enrollment of the first 1,000 patients, which is expected to occur during the second quarter of 2014.
ABOUT REGADO BIOSCIENCES
Regado Biosciences, Inc., is a biopharmaceutical company focused on the development of novel, first-in-class, actively controllable antithrombotic drug systems for acute and sub-acute cardiovascular indications. Regado is pioneering the development of two-component drug systems consisting of a therapeutic aptamer and its specific active control agent. The company’s lead product candidate, REG1, is a two-component system consisting of pegnivacogin, an anticoagulant aptamer specifically targeting coagulation Factor IXa, and its complementary oligonucleotide active control agent, anivamersen. REG1 is currently being evaluated in the REGULATE-PCI trial, a worldwide Phase 3 study enrolling 13,200 patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI), a hospital-based procedure used to mechanically open or widen obstructed coronary arteries. Regado’s actively controllable product candidates have the potential to improve patient outcomes, enhance the patient experience and reduce overall treatment costs. More information can be found at www.regadobio.com.
For more information on REGULATE-PCI, please visit:
http://www.clinicaltrials.gov/ct2/show/NCT01848106
1Vavalle JP, Povsic TJ, Aberle LH, Zelenkofske SL, Mehran R, Kasprzak JD, Bode C, Buller CE, Montalescot G, Cornel JH, Becker RC, Alexander JH, Cohen MG. Safety of Very Early Sheath Removal in Patients Treated With REG1 for Acute Coronary Syndromes: Insights From the RADAR Trial. J Invasive Cardiol. 2013 Nov;25(11):593-9.
SOURCE: Regado Biosciences
Post Views: 674
