Cordex Pharma Submits to the FDA an Amended Special Protocol Assessment for ATPace
To address the FDA’s main comments, Cordex has changed the design of the pivotal clinical trial as follows:
(1) To demonstrate drug efficacy and establish an optimal dose-regimen: A parallel four-arm trial design will consist of three doses of ATPace (5, 10, and 20 mg) and placebo. (2) To demonstrate drug safety: The number of studied patients receiving the initial dose per proposed drug's label has been increased to 100.
Cordex will host a teleconference on
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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
ATPace is an investigational stable formulation of adenosine 5′-triphosphate (ATP) administered by intravenous injection for the acute termination of PSVT. The bradycardic effect of ATP, in particular its blockade of atrio-ventricular (AV) nodal conduction, has been shown in multiple published clinical studies to safely and effectively terminate re-entrant PSVT involving the AV node. Injectable formulations of ATP, similar to ATPace, have been approved and marketed in
Currently, adenosine is the only approved drug for the acute treatment of PSVT in
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, our ability to generate efficacy and safety data required for the marketing approval of ATPace, and the effects of the initial doses of ATPace. 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 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, 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.