Phase 3 clinical oversight and regulatory services for Cordex's ATPace arrhythmia drug to be provided by Cato Research
LA JOLLA, Calif., Feb. 23 /PRNewswire-FirstCall/ -- Cordex Pharma, Inc. (OTC Bulletin Board: CDXP) announced today that it has entered into a long-term strategic master services equity agreement with Cato BioVentures.
As part of this agreement, Cato BioVentures will, at the request of Cordex, arrange for Cato Research to perform regulatory services and oversight of clinical testing of Cordex's investigational drug products. Initially, the collaboration will focus on Cordex's Phase 3 pivotal clinical trial with ATPace for the treatment of paroxysmal supraventricular tachycardia (PSVT). Under the agreement, a portion of Cato's compensation for rendered services will be in the form of Cordex equity.
PSVT is an episodic, rapid, regular heart rate originating in the atria. The heart rate in PSVT can range from 150-250 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.
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 Europe as pharmaceuticals for over 50 years as safe and efficacious treatments for PSVT.
Currently, adenosine is the only approved drug for the acute treatment of PSVT in the United States. Cordex believes that the initial dose of ATPace will be significantly more efficacious than the initial labeled dose of adenosine in terminating PSVT. While both ATP and adenosine inhibit AV nodal conduction, ATP is believed to have dual inhibitory action, one mediated by adenosine, the product of ATP's rapid enzymatic degradation, and the other a rapid and potent ATP-triggered vagal reflex. Physical vagal maneuvers aimed at enhancing vagal tone to the heart, and thereby suppressing atrio-ventricular nodal conduction, have been clinically used to terminate tachycardia in certain cases.
Cordex has submitted its pivotal Phase 3 ATPace clinical trial protocol for review under a Special Protocol Assessment (SPA) procedure with the U.S. Food and Drug Administration. Subject to securing an agreement with the FDA, Cordex intends to initiate a prospective, double-blind, placebo-controlled and randomized Phase 3 clinical trial with ATPace. This trial will be aimed at demonstrating clinical safety and efficacy of ATPace in treating patients with PSVT in the emergency room. Upon successful completion of the trial, Cordex intends to file a New Drug Application under section 505(b)(2).
In addition to its use as an acute therapeutic, ATPace is expected to become the first diagnostic drug, which identifies bradycardic syncope patients who could benefit from cardiac pacemaker therapy. The only approved diagnostic for this purpose is the Implantable Loop Recorder (ILR), a medical device that is surgically implanted in the patient's chest. We believe that ATPace will offer a quick, safe and cost-effective alternative to the ILR.
Cordex estimates that the therapeutic and diagnostic applications of ATPace would address a combined market valued at $100 to 150 million annually.
"I look forward to a long, productive and mutually beneficial relationship with Cordex," said Allen Cato, M.D., Ph.D., President and CEO of Cato Research, Ltd. "With over 50 years of clinical use in Europe of similar injectable ATP formulations for PSVT, we believe Cordex's ATPace represents an excellent balance of risk-reward that we are glad to be associated with as regulatory and clinical service providers and Cordex shareholders."
James S. Kuo, M.D., Cordex's Chairman and CEO, said, "We are very pleased to have the expertise of the Cato team involved in all aspects of the final clinical testing and preparation of the New Drug Application under section 505(b)(2). Through this agreement, we are able to tap into the vast regulatory experience of the entire global Cato organization. We believe that Cato's willingness to collaborate and become Cordex's shareholder maximizes our chances of an efficient clinical testing and drug approval process," he added.
About Cato BioVentures
Cato BioVentures is the venture capital affiliate of Cato Research Ltd. For nearly 20 years, Cato BioVentures has assisted entrepreneurs and established management teams in building successful life science companies. Through strategic CRO service agreements with Cato Research, Cato BioVentures invests its in-kind CRO Service Capital in innovative therapeutics, medical devices, diagnostics and platform tools and technologies for improved drug discovery and development, offering promising life science companies immediate access to a broad range of essential CRO services on a noncash basis. Access to these time-critical CRO services enables management to achieve key value-added development and regulatory milestones with less reliance on other sources of capital. Cato BioVentures has offices in Boston's Bay Colony, Research Triangle Park and Silicon Valley. www.catobioventures.com
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 effect of initial doses of ATPace, the benefits of ATPace, the estimated market of the applications of ATPace, the filing of A new Drug Application and our chances of an efficient testing and drug approval process. 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, 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.|
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