Cordex Receives Special Protocol Assessment Approval from FDA for ATPace
LA JOLLA, Calif., June 2 /PRNewswire-FirstCall/ -- Cordex Pharma, Inc. (OTC Bulletin Board: CDXP) announced today that the U.S. Food and Drug Administration (FDA) has approved the design of pivotal, Phase 2b/3 clinical trials evaluating its lead product ATPace(TM) as an antiarrhytmic drug for the acute treatment of patients with paroxysmal supraventricular tachycardia (PSVT) under the Special Protocol Assessment (SPA) process.
ATPace(TM) is a novel stable liquid formulation of adenosine 5'-triphosphate (ATP). It is being developed as a therapeutic and diagnostic drug for the management of patients with cardiac arrhythmias. ATP has been used in Europe for more than five decades as the drug of choice for the acute termination of PSVT. During this extended period of time, formulations of ATP have manifested an excellent safety and efficacy profile.
Cordex intends to initiate prospective, double-blind, placebo-controlled and randomized clinical trials with its lead product ATPace(TM) in approximately 200 patients aimed at demonstrating clinical safety and efficacy sufficient to support a New Drug Application filing of ATPace(TM) for the treatment of PSVT in emergency room patients.
"We are very pleased with the FDA's decision; we believe that data to be obtained in the proposed trials would constitute sufficient evidence to support the marketing approval of ATPace(TM) for the proposed indication," commented Amir Pelleg, Ph.D., Cordex's President and CSO. "Due to its unique mechanism of action in the heart, which involves a central vagal reflex and adenosine, the product of its rapid degradation, ATPace(TM) has the potential to be an important advance in the treatment of patients with PSVT," he added.
About PSVT
PSVT is an episodic, rapid, regular heart rate originating in the atria. The heart rate in PSVT can range from 150 to 250 beats per minute. There are approximately 570,000 persons with PSVT in the United States alone, with an estimated 89,000 new cases diagnosed each year. Patients with PSVT may report palpitations, pounding in the chest, chest pressure or pain, weakness, shortness of breath, or dizziness. Unless it self-terminates, PSVT patients need to seek medical intervention to terminate the arrhythmia.
About Cordex Pharma, Inc.
Cordex is a specialty pharmaceutical company that develops new cardiovascular medicines based upon the emerging pharmacology of adenosine triphosphate (ATP) and nitric oxide (NO). These two molecules play critical roles in cellular metabolism and signal transduction, the manipulation of which constitute novel therapeutic modalities for the treatment of major cardiovascular disorders. Cordex has a portfolio of investigational medicines, two of which are in late stages of clinical development. ATPace(TM) is expected to enter a Phase 2b/3 clinical trial for the treatment of paroxysmal supraventricular tachycardia. Cordex's CDP-1050 is expected to commence a Phase 2 clinical trial for the treatment of heart failure. 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 diseases. For further information regarding Cordex, please visit the company's website at www.cordexpharma.com.
Forward-looking Statements
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended that involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements. The forward-looking statements are based on current expectations, estimates and projections made by management. Cordex intends for the forward-looking statements to be covered by the safe harbor provisions for forward-looking statements. Words such as "anticipates," "expects," "intends," "plans," "believes," "seeks," "estimates," or variations of such words are intended to identify such forward-looking statements. All statements in this release regarding the future outlook related to Cordex are forward-looking statements, including, but not limited to, the statements regarding the timing of ATPace(TM)'s expected entry into a pivotal Phase 2b/3 clinical trial for the treatment of paroxysmal supraventricular tachycardia, the sufficiency of the data obtained and the anticipated results of the trial, the timing of CDP-1050's expected commencement of a Phase 2 clinical trial for the treatment of heart failure, the expected results of the use of ATPace(TM) and the estimated PSVT market. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements. Such risks include the risk that the data derived from the trial may not be sufficient to support marketing of approval of ATPace(TM), clinical trial for approval of ATPace(TM) and the Phase 2 clinical trial for our CDP-1050 may not be successful, that our preclinical program to develop new chemical entities that target a newly discovered pathway in the pathophysiology of chronic obstructive pulmonary disease may not be successful, the market may not be as anticipated and that our technology may not lead to expected results including the development or the successful commercialization of technologies relating to the use of ATP or nitric oxide. Additional uncertainties and risks are described in Cordex's most recently filed SEC documents, such as its most recent annual report on Form 10-KSB, all quarterly reports on Form 10-Q and any current reports on Form 8-K filed since the date of the last Form 10-KSB. Copies of these filings are available through the SEC website at http://www.sec.gov. All forward-looking statements are based upon information available to Cordex on the date hereof. Cordex undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, other than as required by law.