LA JOLLA, Calif., June 29 /PRNewswire-FirstCall/ -- Cordex Pharma, Inc. announced today that it has successfully completed the production of the ATPace(TM) clinical trial material (CTM) in preparation for planned pivotal clinical trials. The protocol of these clinical trials has been approved by the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment process.
ATPace(TM) 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. A stable liquid formulation of ATP is a prerequisite for ATPace(TM)'s clinical superiority over adenosine, the only approved competition in the U.S. 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. Cordex has filed a formulation patent covering this stable liquid formulation of ATP for intravenous administration.
The ATPace(TM) CTM was produced off-site 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 over 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(TM)'s NDA under section 505b(2).
“We are pleased to reach this important milestone in the development program of ATPace(TM),” said Amir Pelleg, Ph.D., Cordex’s President and CSO. “Together with Cato Research, we are looking forward to commencing the pivotal studies with the manufactured ATPace(TM) CTM in accordance with the protocol approved under the FDA’s SPA process,” 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 5'-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 pivotal 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 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 use of the CTM in the planned trials and the use of the European data as part of the NDA. 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 trials may not be sufficient to support marketing of approval of the products, clinical trial for approval of ATPace(TM) and the Phase 2 clinical trial for our CDP-1050 may not be successful, the results of the clinical trial for ATPotent(TM) may not be as expected, 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-K, 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.
CONTACT: James Kuo of Cordex Pharma, Inc., +1-858-551-5700,
jkuo@cordexpharma.com
Web site: http://www.cordexpharma.com/
