Navigation Links
Regado Biosciences Permanently Halts REGULATE-PCI Clinical Trial
Date:8/25/2014

BASKING RIDGE, N.J., Aug. 25, 2014 /PRNewswire/ -- 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

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the progress of the REGULATE-PCI trial, the expected timing and outcome of our analysis of the unblended REGULATE-PCI database, the prospects for the continued development and any regulatory approval of Revolixys™ Kit and the successful commercialization of Revolixys™ Kit, if approved. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Factors that could cause future results to materially differ from those projected in forward-looking statements include the outcome of our database analysis, our determination of the safety and/or efficacy of Revolixys™ Kit as well as the "Risk Factors" described in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 12, 2014, and in the Company's other periodic filings with the SEC. All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. The Company has no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.

Media Contact:
David Schull
Russo Partners
212-845-4271
david.schull@russopartnersllc.com

Investor Relations Contact:
Don Elsey, CFO
Regado Biosciences, Inc.
908-580-2113
delsey@regadobio.com


'/>"/>
SOURCE Regado Biosciences, Inc.
Copyright©2014 PR Newswire.
All rights reserved

Related medicine technology :

1. Regado Biosciences to Provide Second Quarter 2014 Financial Results and Corporate Highlights
2. Attention Regado Biosciences, Inc. Investors: Regado Misled Investors According to a Recently Filed Class Action
3. Regado Biosciences, Inc. Adds World-Class Interventional Cardiologist and Researcher to Medical Advisory Board
4. Regado Biosciences, Inc. Adds Global Pharmaceutical Business Veteran to Board of Directors
5. Regado Biosciences, Inc. Announces Third Quarter 2013 Results
6. Regado Biosciences, Inc. Announces Closing of Initial Public Offering
7. Regado Biosciences, Inc. Announces Pricing of Initial Public Offering
8. Regado Biosciences, Inc. to Present at the Oppenheimer 23rd Annual Healthcare Conference in New York, NY
9. Regado Biosciences, Inc. to Present at the UBS Global Life Sciences Conference 2012 in New York, NY
10. Regado Biosciences, Inc. to Present at the Canaccord Genuity 32nd Annual Growth Conference in Boston, MA
11. Regado Biosciences, Inc. to Present at the 2012 Wedbush PacGrow Life Sciences Conference in New York, NY
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/3/2016)... , May 3, 2016  While you may be familiar with watching a film or ... also known as ultra-high-definition or 8MP in the Medical Industry.  Ampronix  is a renowned authorized ... innovative technology. Photo - http://photos.prnewswire.com/prnh/20160502/362730 ... ... ...
(Date:5/3/2016)... Pharmacy, Inc. (NYSE: DPLO) announced today that it is celebrating Hepatitis Awareness Month with a ... tell their personal story and encourage those at risk to get tested and begin the ... ... ... Specialty Pharmacy (PRNewsFoto/Diplomat Pharmacy, Inc.) ...
(Date:5/3/2016)... YORK , May 3, 2016 ... (MRI) Market Size, Share, Development, Growth and Demand Forecast ... Open), by Field Strength (High Field, Very High Field, ... Application (Brain, Head and Neck, Spine, Musculoskeletal, Vascular, Breast, ... the global magnetic resonance imaging (MRI) market was valued ...
Breaking Medicine Technology:
(Date:5/3/2016)... ... May 03, 2016 , ... California ... a web application that helps people assess their risk of developing Alzheimer’s disease. ... will provide users a “Risk Reduction Score™” that summarizes how their lifestyle choices ...
(Date:5/3/2016)... ... May 03, 2016 , ... Horizon ... has been honored as one of the nation’s most accomplished business technology innovators ... Horizon received the recognition for technology achievements that have enabled the delivery of ...
(Date:5/3/2016)... Texas (PRWEB) , ... May 03, 2016 , ... Excessive ... the signs of pet anxiety. "Pet owners often think anxiety only manifests itself ... stress signals in other ways, and there’s things that be done about it,” says ...
(Date:5/3/2016)... ... ... personal injury law firm Monge & Associates is honoring Moms in the time ... for their Mother or any other mother figure. , According to law firm founder, Scott ... on to say, “we are choosing to do this by giving free roses to those ...
(Date:5/3/2016)... ... May 03, 2016 , ... Intrigma, the leading ... Legacy Health is expanding its use of Intrigma’s cloud-based physician scheduling solution, Efficient ... proof of concept. The Portland, Oregon based health system conducted a one-year pilot ...
Breaking Medicine News(10 mins):