Phase 2/3 Clinical Trial Results To Be Released the Week of 6th July
ARYx Therapeutics Inc. (NASDAQ:ARYX), a biopharmaceutical company,
announced today that the database for the EmbraceAC study has been
locked and the study remains on schedule, with the efficacy and safety
results to be available during the week of July 6, 2009. The study was
designed to compare its oral anticoagulation therapy, tecarfarin
(previously ATI-5923), against the leading anticoagulant agent,
warfarin. The purpose of the trial is to evaluate whether tecarfarin is
superior to warfarin in its ability to maintain patients within a target
therapeutic range of the level of anticoagulation as measured by INR
(International Normalized Ratio). Based upon recent interactions with
the U. S. Food and Drug Administration (FDA), ARYx believes this trial
could be positioned as one of the required registration studies for
tecarfarin.
The raw data, containing both the efficacy and safety results, will now
be transferred to independent statisticians who will create the tables
and listings according to the previously adopted statistical analysis
plan. This plan has been reviewed by the FDA. The results from the study
will remain blinded to ARYx until just prior to their public release.
The trial of approximately 600 patients is a randomized, double blind,
parallel group, active control study comparing tecarfarin with warfarin
in patients who require chronic, oral anticoagulation. All patients in
the study were treated for a minimum of six months and required
anticoagulation therapy to avoid serious blood clotting resulting from
their underlying condition. This includes patients with atrial
fibrillation; an implanted prosthetic heart valve; a history of venous
thromboembolic disease; a history of myocardial infarction or
cardiomyopathy; or another indication for which they are currently
receiving chronic warfarin therapy. The same target therapeutic range of
INR has been applied for patients receiving warfarin therapy as those
administered tecarfarin.