Navigation Links
Regado Biosciences Permanently Halts REGULATE-PCI Clinical Trial

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 and will be archived there for 60 days following the call.


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 For more information on REGULATE-PCI, please visit:

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

Investor Relations Contact:
Don Elsey, CFO
Regado Biosciences, Inc.

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:
(Date:11/26/2015)... DUBLIN , November 26, 2015 ... has announced the addition of the  ... in the European Cell Surface Marker ... Emerging Opportunities"  report to their offering.  ... announced the addition of the  "2016 ...
(Date:11/25/2015)... 2015  Amgen (NASDAQ: AMGN ) today announced ... the United States (U.S.) Food ... candidate to Humira ® (adalimumab). Amgen believes this ... the FDA and represents Amgen,s first BLA submission using ... , M.D., executive vice president of Research and Development ...
(Date:11/25/2015)... , Nov. 25, 2015 AAIPharma Services ... investment of at least $15.8  Million to expand ... Wilmington, NC . The expansion will provide ... meet the growing demands of the pharmaceutical and ... site expansion will provide up to 40,000 square ...
Breaking Medicine Technology:
(Date:11/28/2015)... ... ... 6:00 a.m. EST until 11:59 p.m. EST, customers will be racing the ... orders $80 or more to free gifts with purchases, there will be a new sale ... website for skin care and cosmetic needs, customers will save on already discounted prices. , ...
(Date:11/27/2015)... ... 27, 2015 , ... According to an article published November 13th ... in Washington D.C. revolved around the fact that proper dental care, both at-home and ... the link between periodontal disease (more commonly referred to as gum disease) and diabetes. ...
(Date:11/27/2015)... ... November 27, 2015 , ... The ... in America. As people age, more care is needed, especially with Alzheimer’s, dementia ... medical professionals are being overworked. The forgotten part of this equation: 80 percent ...
(Date:11/27/2015)... (PRWEB) , ... November 27, 2015 , ... ... filthy the toilets were," said an inventor from Hillside, N.J. "Many people catch ... seat cover so that individuals will always be protected from germs." , He ...
(Date:11/27/2015)... ... , ... ProSidebar: Fashion is a set of 30 kinetic edge ... video editors can easily add an informative sidebar to any FCPX production. Create ... featuring self-animating drop zones, lines, bars, and text with the ease of FCPX's drag ...
Breaking Medicine News(10 mins):