Biotech Values

[RockRat]

Regado: Reg1 results

That seems to be a bad link, so I'll just paste off their website. The actual abstract might be more illuminating; this PR is rather short on data . . .

>>Regado Biosciences, Inc. Presents Pharmacokinetic and
Pharmacodynamic (PK/PD) Substudy Results from its Phase 2b
RADAR Trial at the American Heart Association (AHA)
Scientific Sessions 2010 Meeting

Basking Ridge, NJ – November 16, 2010 - Regado Biosciences, Inc., a privately held company leading the development of antithrombotic aptamers with active control agents, announced that Thomas J. Povsic, MD, Ph.D., Duke University Medical Center, presented an abstract at the AHA Scientific Sessions meeting on November 16, 2010 at 10:45 a.m. CST in Chicago, IL.

The abstract, entitled "RB006, a Direct Factor IX Inhibitor Results in Consistent and Near Complete Inhibition of Factor IX in Patients with Acute Coronary Syndromes: A RADAR Pharmacokinetic and Pharmacodynamic Substudy," evaluated the appropriateness of the selected dose of pegnivacogin (a.k.a. RB006) for use in patients with Acute Coronary Syndromes. RB006 is part of the REG1 anticoagulation system.

Regado's ongoing Phase 2b clinical trial titled: "Randomized, Partially-Blinded, Multi-Center, Active-Controlled, Dose-Ranging Study Assessing the Safety, Efficacy, and Pharmacodynamics of the REG1 Anticoagulation System Compared to Unfractionated Heparin or Low Molecular Heparin in Subjects with Acute Coronary Syndrome," (a.k.a. RADAR) is a partially blinded study currently enrolling 800 patients in more than 90 centers worldwide. Patients were randomly allocated [4:1] to receive open-label RB006 or unfractionated heparin prior to catheterization and underwent various levels of double blind reversal at the end of the procedure. This substudy, conducted in the open label portion of RADAR, included thirty patients, 20 of whom had not received recent unfractionated heparin. It assessed PK/PD measurements just prior to and 10 minutes after dosing with RB006. PK/PD assessments were also made, both prior to and after cardiac catheterization and before blinded dosing of anivamersen (a.k.a. RB007), RB006's complementary active control agent. The objective was to evaluate the appropriateness of the selected RB006 dose.

The data from this abstract demonstrated that RB006 (1mg/kg, IV) results in consistent and near complete inhibition of FIX in patients with ACS with stable anti-coagulation throughout catheterization (PCI). These findings further validate the dosing of RB006 for Regado's ongoing and planned clinical trials.

The abstract is coauthored by Thomas J. Povsic, MD, Ph.D., Richard A. Becker, MD, and John H. Alexander, MD, MHS, all from Duke University Medical Center; Christopher P. Rusconi, Ph.D., Steven L. Zelenkofske, D.O., both from Regado Biosciences; and William Wargin, Ph.D., President of PK-PM Associates, LLC; Mauricio G. Cohen, MD, University of Miami Miller School of Medicine; Roxana Mehran, MD, Mount Sinai School of Medicine; Christoph Bode, MD, University of Freiburg, Germany; Joshua Krasnow, MD, Heart Center Research, LLC.; and Meril Krolick, D.O., Heart and Vascular Institute of Florida. <<

Regards, RockRat