ARYx Completes Enrollment in Phase II/III Anticoagulation Comparison Study
Posted on: Tuesday, 4 November 2008, 09:00 CST
ARYx Therapeutics, a biopharmaceutical company, has completed enrollment in EmbraceAC, a Phase II/III double-blind clinical trial comparing its oral anticoagulation therapy, ATI-5923, against the leading anticoagulant agent, warfarin.
The purpose of the trial is to evaluate whether ATI-5923 is superior to warfarin in its ability to maintain patients within a target therapeutic range of the level of anticoagulation as measured by international normalized ratio (INR). Based upon recent interactions with the FDA, ARYx believes this trial could be positioned as one of the required registration studies for ATI-5923.
The trial has enrolled approximately 600 patients at 48 clinical study sites in the US. It is a randomized, double-blind, parallel group, active control study comparing ATI-5923 with warfarin in patients who require chronic, oral anticoagulation. The patients who enter this study will be treated for a minimum of six months and require anticoagulation therapy to avoid serious blood clotting resulting from any of their underlying conditions.
The same target therapeutic range of INR is being applied for patients receiving warfarin therapy as those administered ATI-5923. The primary endpoint of the trial is to demonstrate that patients are maintained within the target INR range a higher percentage of the time when treated with ATI-5923 than with warfarin.
Paul Goddard, chairman and CEO of ARYx, said: "By completing enrollment in EmbraceAC now, we are assured of delivering the results by our milestone date of the end of the first half of 2009."
Source: Datamonitor
Related Articles
- New Data Shows Breakthrough microRNA-Targeted Therapy Developed Using Santaris Pharma A/S Proprietary LNA Technology Holds Promise as New Treatment for Hepatitis C
- Video: Data on More Than 15 Novartis Oncology Compounds at ASCO Highlight Progress Toward Targeted Therapies for Diverse Tumor Types
- Two Targeted Therapies Likely Better Than One in Patients with Aggressive Lymphoma, Mayo Clinic Researchers Say
- SeqWright Expands into the Genetically-Targeted Therapy Field by Partnering with PharmaGenoma to Provide Next-Generation Hair Loss Treatment Genetic Testing
- Pacgen Completes Patient Recruitment for Phase II Dose Ranging Trial of Novel Anti-Fungal Drug
- Isolagen Initiates Phase III Trial for Acne Scars Therapy
- In 2007, There Were 11 Highly Successful Targeted Cancer Blockbusters According To The New Report 'Oncology Pipelines: Is The Future Targeted Therapy?'
- Gastric Cancer - Targeted Therapies Home In on a Neglected Tumor
- A Lot of Targeted Therapies Coming into the Market Now Require the Use of a Diagnostic.
- Investigational Targeted Therapy May Offer Progress for Non-Hodgkin's Lymphoma Patients
 |
 |
User Comments (0)
RSS Feeds