LA JOLLA, Calif., March 4 /PRNewswire-FirstCall/ -- Cordex Pharma, Inc. (OTC Bulletin Board: CDXP) announced today that it has filed a formulation patent covering its lead product, ATPace.
ATPace is a stable liquid formulation of adenosine triposphate (ATP) for intravenous administration. ATPace is being developed as a therapeutic drug for the acute management of paroxysmal supraventricular tachycardia (PSVT) as well as a diagnostic test for the identification of patients with bradycardic (slow heart rate) syncope who may benefit from pacemaker therapy. Injectable formulations of ATP, similar to ATPace, have been approved and marketed in Europe for over 50 years as safe and efficacious pharmaceutical treatments for PSVT.
Cordex has recently announced the submission to the FDA of an amended Phase 3 clinical trial protocol with ATPace as an antiarrhythmic drug for the conversion of PSVT to normal sinus rhythm. The FDA is currently reviewing this protocol through the Special Protocol Assessment procedure.
A stable liquid formulation of ATP is a prerequisite for ATPace's marketing and clinical superiority over adenosine, the only approved competition in the U.S. The maintenance of intact ATP molecules in the solution is critical for the unique bradycardic effects of ATP, in particular its blockade of atrio-ventricular (AV) nodal conduction. Specifically, ATP is believed to have dual inhibitory action, one mediated by adenosine, the product of its rapid degradation in the blood vasculature by ecto-enzymes, and the other a rapid and potent ATP-triggered vagal reflex. The latter mechanism of action is believed to be responsible for its superior efficacy over adenosine, which does not trigger a vagal reflex in the heart. Physical vagal maneuvers aimed at enhancing vagal input to the heart, and thereby suppressing atrio-ventricular nodal conduction, have been clinically used to terminate tachycardia in certain cases.
"We are very pleased with the unmatched stability of our proprietary formulation, which is over four years. It ensures a reliable product that maintains its pharmacologic profile throughout its shelf life," commented Amir Pelleg, Ph.D., Cordex's President and CSO. "This patent application will add additional coverage to that afforded by existing patents and other pending patent applications," he added.
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. 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. For further information regarding Cordex, please visit the company's website at www.cordexpharma.com.
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's expected entry into a pivotal Phase 3 clinical trial for the treatment of paroxysmal supraventricular tachycardia 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 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 patent filing may not provide the protection that is anticipated, clinical trial for approval of ATPace 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.
|SOURCE Cordex Pharma, Inc.|
Copyright©2009 PR Newswire.
All rights reserved