LA JOLLA, Calif., Feb. 11 /PRNewswire-FirstCall/ -- Cordex Pharma, Inc. (OTC Bulletin Board: CDXP) announced today the formation of a Medical Advisory Board to provide clinical guidance for the Company's development program of CDP-1050 for the treatment of heart failure.
Advertisement
The Medical Advisory Board will play an important supportive role in the design and oversight of the planned CDP-1050 Phase 2 clinical trial and assist in addressing regulatory and patients' welfare issues. It is composed of internationally recognized leaders in the field of heart failure; all of whom have extensive experience in the design and execution of clinical trials aimed at improved care of patients with heart failure.
Advertisement
CDP-1050 is being developed as a new therapeutic modality in the management of heart failure. It targets the redox-nitiric oxide imbalance, which is increasingly recognized as a major factor in poor myocardial contractile efficiency, the hallmark manifestation of this disorder.
The Medical Advisory Board is chaired by Joshua M. Hare, M.D., the Louis Lemberg Professor of Medicine, Chief of the Division of Cardiology, and Director of the Interdisciplinary Stem Cell Institute at University of Miami, Miller School of Medicine. He has pioneered the use of stem cell therapy to repair damaged hearts. Dr. Hare has authored and co-authored numerous peer-reviewed publications including a report on a multi-center clinical trial with oxypurinol, a modifier of cellular redox potential, in patients with symptomatic heart failure. He served as the principal investigator of that clinical trial. Dr. Hare has also authored a New England Journal of Medicine editorial on redox-nitric oxide balance in the cardiovascular system.
Other members of the Medical Advisory Board include:
Wilson S. Colucci, M.D., is the Thomas J. Ryan Professor of Medicine and Professor of Physiology at Boston University School of Medicine. He is also the Chief of Cardiovascular Medicine, Director of the Myocardial Biology Unit, Director of the Cardiomyopathy Program and Co-Director of the Cardiovascular Center at Boston Medical Center.
Howard J. Eisen, M.D., F.A.C.C., F.A.C.P., F.A.H.A., is the Thomas J. Vischer, Professor of Medicine and Chief of the Division of Cardiology at Drexel University, College of Medicine. He is also Director of the Drexel Center for Cardiovascular Disorders and The Center for Advanced Heart Failure Care at Hahnemann University Hospital.
Douglas L. Mann, M.D., F.A.C.C., F.A.C.P., is Chief, Division of Cardiology, Lewin Chair and Professor of Medicine, Washington University in St. Louis, Cardiologist-in-Chief, Barnes Jewish Hospital.
Richard P. Schwarz, Ph.D., is President of CV Ventures, LLC, a consulting firm specialized in the design and execution of clinical trials and an Adjunct Professor at University of Miami.
Jonathan S. Stamler, M.D. is the George Barth Geller Professor of Research in Cardiovascular Diseases and Professor of Medicine and Biochemistry at Duke University.
Dr. Hare stated, "I am pleased to have a group of distinguished colleagues joining me in support of the clinical development program of CDP-1050. Their remarkable clinical experience and expertise is a significant asset of the program. CDP-1050 is a novel directed approach for the treatment of heart failure, and it is gratifying to be involved in what we hope will be a paradigm shift in this disease treatment."
"We are honored to be working with such knowledgeable and experienced individuals in the development of CDP-1050," said Amir Pelleg, Ph.D., Cordex's President and CSO. "Progressive heart failure is a growing and vexing medical problem around the world. It is perhaps one of the largest untapped pharmaceutical markets. Currently available drugs prolong the lives of patients with this condition, however, surprisingly little innovative research is being translated to new medicines. With the help of our Medical Advisory Board, we hope to demonstrate the clinical safety and efficacy of CDP-1050 in an efficient and convincing manner to the satisfaction of the medical community and regulatory authorities alike. Eventually, we hope to make the drug available to treat the desperately ill heart failure patients worldwide."
About Heart Failure
Heart failure, a condition characterized by the inability of the heart to effectively pump blood as well as by fluid accumulation in the lungs and other tissues, is suffered by an estimated five million Americans and is responsible for 300,000 deaths in the U.S. annually, according to the National Heart, Lung and Blood Institute. It is the single largest Medicare expense, at a cost of $33.2 billion each year. The five-year mortality rate with heart failure can be as high as 50 percent.
About CDP-1050
CDP-1050 is an investigational drug candidate for the treatment of heart failure. The drug is designed to correct the nitric oxide and redox imbalance in the failing heart and the cardiovascular system. CDP-1050 has a dual mechanism of action; it inhibits the production of excessive reactive oxygen radicals and restores nitric oxide to physiologic levels. The primary therapeutic target is the ryanodine receptor, the main ion channel in the heart that supplies the calcium necessary for the heart to contract. CDP-1050 is expected to enter a Phase 2 clinical trial this year.
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.
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 CDP-1050 as a paradigm for the treatment of heart failure, satisfaction of the medical community and regulatory authorities as to the safety and efficacy of CDP-1050, the availability of CDP-1050 worldwide to treat ill heart failure patients, 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, and CDP-1050's expected commencement of a Phase 2 clinical trial for the treatment of heart failure. 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.
