Anticoagulation and Monitoring of a Novel and Reversible Factor IXa Inhibitor

Authors


  • Funding/support information: Regado Biosciences funded the clinical trials.
  • Disclosures of commercial interests, and roles are as follows: Richard C. Becker, MD—Astra Zeneca (Principal Investigator), Bayer Pharmaceuticals (Principal Investigator), BMS (Lab Research), Johnson & Johnson (Lab Research), Portola (Advisory Board Member), Boehringer Ingelheim (Advisory Board Member), Daiichi-Sanko (Advisory Board Member), Merck (Advisory Board Member), Bayer Pharmaceuticals (Advisory Board Member); Mark Y. Chan, MBBS, MHS—None; John P. Vavalle, MD—None; Thomas J. Povsic, MD—Baxter Healthcare (Principal Investigator), Revalesio Inc. (Principal Investigator).

Abstract

Clinical Development Phases I-III Regulatory, Quality, Manufacturing

Thrombosis as a clinical phenotype is ubiquitous in human diseases and conditions, ranging from atherosclerosis and other vascular disorders to trauma, surgery, malignancy, infections, blood dyscrasias, auto-immunity, and complications of pregnancy. While each condition carries its own distinct signature and predisposition for thrombosis as a nonphysiological event, there are several common themes that center on cellular and noncellular elements, including well-characterized coagulation proteases. Over the past decade, our group has been actively involved with the development of a factor IXa inhibitor, pegnivacogin, and its complementary antidote or control agent, anivamersen. The following review provides a summary of fundamental constructs, milestones, and the current status of our translational journey.

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