According to Cordex, the amendment addresses written comments recently received from the FDA in response to the company’s initial special protocol assessment (SPA) submission to the FDA in November 2008.
Amir Pelleg, Cordex’s president and chief scientific officer, said: We are very pleased with the FDA’s timely response to our initial ATPace SPA submission. We now believe that the written correspondence from the FDA, which clearly outlines all study-design requirements and clinical endpoints, would enable us to generate the efficacy and safety data required for the marketing approval of ATPace.
We look forward to initiating the pivotal Phase III clinical trial for ATPace in paroxysmal supraventricular tachycardia patients.
Cordex is a specialty pharmaceutical company that develops new cardiovascular medicines based upon the emerging pharmacology of adenosine triphosphate and nitric oxide. Cordex also has a portfolio of investigational medicines, two of which are in late stages of clinical development. Cordex’s ATPace is expected to enter a Phase 3 clinical trial for the treatment of paroxysmal supraventricular tachycardia in 2009. Cordex’s CDP-1050 is also expected to commence a Phase 2 clinical trial for the treatment of heart failure in 2009. In addition, Cordex has a preclinical program to develop new chemical entities that target a recently discovered pathway in the pathophysiology of chronic obstructive pulmonary disease.