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Who is Cordex Pharma, Inc.?
Cordex Pharma, Inc. (Cordex) is a specialty pharmaceutical company that develops new cardiovascular medicines based upon the emerging new 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 by several pharmaceuticals constitute novel therapeutic modalities for the treatment of major cardiovascular disorders.
What's in their pipeline?
ATPace:
ATPace (adenosine triphosphate injection) is a proposed product for the acute treatment and diagnosis of certain cardiac arrhythmias (abnormal heart rate). These include the termination of paroxysmal supraventricular tachycardia (PSVT), a rapid regular heart rate originating in the atria. ATPace is also being developed to diagnose bradycardia (slow heart rate), which is one of the main causes of fainting.
Therapeutic Indication:
ATPace, a stable liquid formulation of adenosine 5’-triphosphate (ATP) for intravenous injection, is an investigational drug for the acute termination of PSVT. The bradycardic effect of ATP, in particular its blockade of atrio-ventricular nodal conduction, has been shown in numerous published clinical studies to safely and effectively terminate re-entrant PSVT involving the atrio-ventricular node. Design of a pivotal Phase 3 clinical trial for ATPace in PSVT is in the planning stage.
PSVT, one of the most common cardiac arrhythmias, is a rapid, regular heart rate originating in the atria. It has been estimated that there are 89,000 new cases of PSVT per year and approximately 570,000 persons with PSVT in the United States alone.
Currently, adenosine is the only approved treatment for 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 atrio-ventricular nodal conduction, ATP is believed to have dual inhibitory action; one mediated by adenosine, the product of its rapid enzymatic degradation, and the other a triggered vagal reflex. Vagal maneuvers aimed at enhancing vagal tone to the heart, and thereby suppressing atrio-ventricular nodal conduction, have been clinically used to terminate tachycardia. Injectable formulations of ATP have been approved in Europe for over 50 years as safe and efficacious treatments for PSVT.
Cordex has established its own safety database for ATPace, which was obtained in its Phase 1 and 2 clinical trials, and has obtained more than 1,000 patients records from other clinical trials. On April 16, 2008, Cordex met with the FDA and confirmed that a New Drug Application under section 505(b)(2) would be the appropriate regulatory pathway for filing an ATPace marketing application for the acute treatment of PSVT. Cordex is in the process of modifying the proposed Phase 3 clinical trial in accordance with the FDA’s comments and plans to submit a revised protocol to the FDA for Special Protocol Assessment procedure approval. Cordex intends to initiate a single, prospective, placebo-controlled, and randomized trial in patients presenting to the emergency room with PSVT to demonstrate ATPace’s clinical safety and efficacy. Upon successful completion, Cordex would intend to file a New Drug Application under section 505(b)(2).
CDP-1050:
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.
Cordex's scientific consultants, Jonathan S. Stamler, M.D., and Joshua M. Hare, M.D., have developed and tested new therapeutic modalities to preserve and improve cardiac function. Cordex has been granted an exclusive, worldwide license from Duke University and Johns Hopkins University to develop and commercialize their portfolio of investigational cardiovascular drugs for the treatment of heart failure.
The most advanced heart failure drug candidate in the portfolio is CDP-1050. The drug is expected to enter a Phase 2 clinical study early in 2009. CDP-1050 is designed to correct nitric oxide and redox imbalance in the failing heart and the cardiovascular system. The drug has a dual mechanism of action; it inhibits the production of tissue-damaging reactive oxygen radicals, and restores nitric oxide to physiologic levels. The principal therapeutic target of the drug is the ryanodine receptor, a key calcium-ion channel in the heart that supplies the calcium necessary for the heart to contract. By improving the redox/nitric oxide balance, CDP-1050 is expected to improve the fucnction of the ryanodine receptor and calcium cycling in the heart. These effects at the sub-celluar level, would be manifested on the organ level in increased efficiency of cardiac contractility.
Vagonixen:
Chronic obstructive pulmonary disease (COPD) is a progressive disease that permanently damages the lungs and is usually caused by smoking. COPD is comprised of both emphysema and chronic bronchitis. COPD is the fourth leading cause of death in the U.S. and is on track to become the third leading cause of death by the year 2020. Currently, about 120,000 Americans die each year from COPD. Approximately 16 million patients in the U.S. alone are afflicted with this disease. COPD costs about $42 billion a year in medical bills and lost productivity. On November 29, 2007,
The New York Times wrote that COPD is “the largest uncontrolled epidemic in the United States today.”
Currently, COPD is treated by physicians with a combination of oral steroids, anticholinergics and asthmatic medications. Bronchodilation is a hallmark of current therapy for COPD. ATP is known to cause bronchoconstriction and cough in normal subjects, and more so in patients with obstructive airway diseases. Abnormally high levels of ATP have been measured in the lungs of COPD patients. Cordex’s proprietary technology is comprised of the selective blockade of specific P2R in the lungs that mediate the bronchoconstrictive cough-inducing actions of ATP. By blocking nerve impulses in the afferent neural traffic, bronchoconstriction, cough and neurogenic inflammation should be inhibited in COPD patients.
Cordex is identifying lead compounds that could be developed for the treatment of COPD and chronic cough.
ATPotent:
Male factor infertility is implicated in about half of the 6 million infertile couples in the U.S. Asthenozoospermia, lack of or low sperm motility, is a common cause of human male infertility. It has been reported in the medical literature that the prevalence of asthenozoospermia in infertile men is approximately 82 percent. Currently, there is no FDA-approved product that enhances sperm motility.
Cordex's proprietary ATPotent is being developed as a sperm processing medium to enhance sperm motility in conjunction with in vitrofertilization (IVF) and intrauterine insemination (IUI) procedures. One component of ATPotent is ATP, a naturally occurring biological molecule that is found in all human cells. Naturally occurring ATP in the female reproductive tract is believed to play a facilitating role in normal egg fertilization. Several in vitro studies conducted on sperm of human and other species suggest that ATP treatment of poorly motile sperm resulted in improved motility parameters and increased frequency of hyperactivated sperm.
Results of a study sponsored by Cordex was recently published in the journal of Reproductive Sciences (Scott E. Edwards, et al., "Effects of Extracellular Adenosine 5'-Triphosphate on Human Sperm Motility," 2007; 14: 655-666). The study, conducted by scientists from the Center for Research on Reproduction and Women's Health of the University of Pennsylvania and the Department of Medical and Surgical Sciences of the University of Padova, Italy, showed that ATP treatment of poorly motile human sperm in vitro (outside of the human body) resulted in improved motility parameters and increased frequency of hyperactivated sperm. Furthermore, improved motility parameters were also observed in human sperm derived from males with asthenozoospermia (a disorder characterized by lack of or low sperm motility), and human sperm from cryopreservation.
The authors suggested that these effects of ATP could explain the increased success rate of IVF procedures observed in an earlier non-Cordex sponsored European study, in which ATP-treated sperm derived from infertile males with asthenozoospermia were used.
Cordex believes that the data in this study and other studies strengthen the rationale for the development of ATPotent, which contains ATP, as a novel, sperm motility enhancement medium in conjunction IVF and IUI procedures. Cordex plans a 510(k) FDA medical device approval route and is planning to meet with the FDA to discuss such a regulatory path.
