Safety Stops Phase 3 Study for Revolixys™ Kit
BASKING RIDGE, NJ, USA I August 25, 2014 I Regado Biosciences, Inc. today announced the permanent termination of enrollment in its REGULATE-PCI phase 3 trial for its lead program, Revolixys™ Kit. The decision was made based on a recommendation from the trial’s Data and Safety Monitoring Board (DSMB) following their analysis of the data from the first approximately 3250 patients enrolled in what was intended to be a 13,200-patient trial comparing the safety and efficacy of Revolixys Kit with bivalirudin.
“The DSMB 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,” stated David J. Mazzo, Ph.D., CEO of Regado. He continued, “We will now undertake a complete review of the unblinded database from REGULATE-PCI, which we expect will take several months to complete.”
The Company will hold a conference call and live audio webcast today, Monday, Aug. 25, 2014, at 9:00 a.m. EDT to discuss the termination of its REGULATE-PCI trial.
Interested participants and investors may access the conference call by dialing 1-866-652-5200 for domestic callers or 1-412-317-6060 for international callers. The conference call will be webcast live under the investor relations section of the Regado website at www.regadobio.com and will be archived there for 60 days following the call.
ABOUT REGADO BIOSCIENCES
Regado Biosciences, Inc., is a biopharmaceutical company focused on the discovery and development of novel, oligonucleotide-based actively controllable therapeutics. Our initial focus is on applications in the acute and sub-acute cardiovascular therapeutic area. The company’s lead product candidate, Revolixys™ Kit, is a two-component system consisting of pegnivacogin, an anticoagulant aptamer specifically targeting coagulation Factor IXa, and its complementary oligonucleotide active control agent, anivamersen. Regado’s actively controllable product candidates have the potential to improve patient outcomes and enhance the patient experience, provide direct therapeutic control to physicians 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.
SOURCE: Regado Biosciences
Post Views: 27
Safety Stops Phase 3 Study for Revolixys™ Kit
BASKING RIDGE, NJ, USA I August 25, 2014 I Regado Biosciences, Inc. today announced the permanent termination of enrollment in its REGULATE-PCI phase 3 trial for its lead program, Revolixys™ Kit. The decision was made based on a recommendation from the trial’s Data and Safety Monitoring Board (DSMB) following their analysis of the data from the first approximately 3250 patients enrolled in what was intended to be a 13,200-patient trial comparing the safety and efficacy of Revolixys Kit with bivalirudin.
“The DSMB 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,” stated David J. Mazzo, Ph.D., CEO of Regado. He continued, “We will now undertake a complete review of the unblinded database from REGULATE-PCI, which we expect will take several months to complete.”
The Company will hold a conference call and live audio webcast today, Monday, Aug. 25, 2014, at 9:00 a.m. EDT to discuss the termination of its REGULATE-PCI trial.
Interested participants and investors may access the conference call by dialing 1-866-652-5200 for domestic callers or 1-412-317-6060 for international callers. The conference call will be webcast live under the investor relations section of the Regado website at www.regadobio.com and will be archived there for 60 days following the call.
ABOUT REGADO BIOSCIENCES
Regado Biosciences, Inc., is a biopharmaceutical company focused on the discovery and development of novel, oligonucleotide-based actively controllable therapeutics. Our initial focus is on applications in the acute and sub-acute cardiovascular therapeutic area. The company’s lead product candidate, Revolixys™ Kit, is a two-component system consisting of pegnivacogin, an anticoagulant aptamer specifically targeting coagulation Factor IXa, and its complementary oligonucleotide active control agent, anivamersen. Regado’s actively controllable product candidates have the potential to improve patient outcomes and enhance the patient experience, provide direct therapeutic control to physicians 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.
SOURCE: Regado Biosciences
Post Views: 27
