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A Novel Oral Anticoagulant is Planned to be Developed for Patients with Prosthetic Heart Valves or Chronic Renal Dysfunction
Date:3/8/2013

SUNNYVALE, Calif., March 8, 2013 /PRNewswire/ -- Armetheon, Inc., a clinical stage biopharmaceutical company, announced today that it plans to develop its novel oral anti-coagulant (OAC), tecarfarin (ATI-5923), for a patient population which includes those who have prosthetic heart valves or chronic renal dysfunction. In these patients, currently available OACs are contra-indicated or inadequate. Tecarfarin, a potentially best-in-class OAC, was designed to avoid cytochrome P450 (CYP) related metabolism that is a major cause of safety and efficacy problems related to the use of warfarin (Coumadin®), the current standard of care. In a recently completed phase 3 pivotal clinical trial (EMBRACE-AC), tecarfarin was shown to be safe and effective as an OAC in patients with prosthetic heart valves in addition to those with other conditions  such as atrial fibrillation or venous thromboembolism, independent of their CYP status.

"Anti-coagulation is challenging in patients with prosthetic heart valves, where non-monitored oral anti-coagulation therapies are not  indicated, and where a safe and effective alternative to warfarin would address an important clinical burden," commented Lord Ajay Kakkar , Professor of Surgery, University College London, England.

In December 2012, following a number of fatalities, the FDA informed health care professionals and the public that the novel non-monitored OAC which directly inhibits thrombin should not be used in patients with mechanical heart valves. Experts now recommend that none of the novel non-monitored OACs be used in patients with any type of prosthetic valves.

One of the major causes of unpredictable variability in warfarin anticoagulation response leading to bleeding complications or stroke is its metabolism by the enzyme, CYP2C9.  This variability is further exacerbated if patients have a gene
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SOURCE Armetheon, Inc.
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