June 29, 2009 – Cordex Pharma said today it successfully completed the production of the ATPace clinical trial material (CTM) in preparation for planned pivotal clinical trials. ATPace is a novel, proprietary, stable, injectable formulation of adenosine 5'-triphosphate (ATP) under development as a therapeutic and diagnostic drug for the management of cardiac arrhythmias, said the company.
The protocol of these clinical trials has been approved by the FDA under the special protocol assessment process.
A stable liquid formulation of ATP is a prerequisite for ATPace's clinical superiority over adenosine, the only approved competition in the United States. The maintenance of intact ATP molecules in solution is critical for the unique bradycardic effects of ATP, in particular its blockade of atrio-ventricular nodal conduction, the company said. Cordex has filed a formulation patent covering this stable liquid formulation of ATP for intravenous administration.
The ATPace CTM was produced offsite by a U.S. manufacturer of sterile injectable products under the regulatory supervision of Cordex and Cato Research Inc. The CTM will be used in the planned clinical trials for the acute treatment of patients presenting with paroxysmal supraventricular tachycardia (PSVT) in the emergency room.
Several formulations of ATP have been used in Europe for more than five decades as the drug of choice for the acute conversion of PSVT to normal sinus rhythm. During this extended period of use, ATP manifested an excellent safety and efficacy profile. Cordex intends to use clinical data obtained in Europe as a part of the ATPace's NDA under section 505b(2).
For more information: www.cordexpharma.com