Trial of investigational drug for treatment of advanced heart failure
Phosphagenics Limited (”Phosphagenics”) announced today that it has initiated a phase 1 human clinical trial using its patented drug delivery system, TPM, for the targeted delivery of a leading non steroidal anti-inflammatory drug (NSAID), diclofenac. The trial will compare the bioavailability and penetration of the topically applied Voltaren(R) gel (1% diclofenac), one of the leading
Full Post: Phosphagenics’ diclofenac enters trial phase in humans
UC San Diego Medical Center is currently enrolling patients in a Phase 2 clinical trial of an investigational drug for the treatment of advanced heart failure.
The “Calcium Up-Regulation by Percutaneous Administration of Gene Therapy in Cardiac Disease,” or CUPID, study is evaluating a new gene-based therapy designed to stimulate production of an enzyme that enables the heart to pump more effectively.
Initial data from the first phase of the CUPID trial, reported on November 9th at the American Heart Association Scientific Sessions 2008, demonstrated that the drug had an acceptable safety profile in the first group of patients. This study will be the second phase of the trial.
“The CUPID trial is designed to rescue a failing heart by replacing an enzyme known to play a critical role in healthy cardiac function,” said Barry Greenberg, M.D., director of the Advanced Heart Failure Program at UC San Diego Medical Center and president of the Heart Failure Society of America. “The objective of the study is not only to improve the symptoms of heart failure, but importantly, to reverse the severity of the disease in patients.”
The Phase 2 trial compares the use of a drug called MYDICAR at two or three dose levels with placebo, an inert substance. CUPID is expected to enroll 46 patients with advanced heart failure at 13 U.S. medical centers. The clinical trial drug is delivered in a single dose directly to the heart muscle during a short outpatient procedure performed in a cardiac catheterization laboratory. CUPID is funded by Celladon Corporation, makers of MYDICAR.
Heart failure is the leading medical cause of hospitalization and is expected to result in estimated direct and indirect costs to the healthcare system in 2008 of $35 billion. Despite important therapeutic advances in drug and device therapies, the prognosis of heart failure patients remains poor.
About 5 million people in the United States have heart failure, and another 550,000 new cases are diagnosed each year. Heart failure contributes to or causes about 280,000 deaths annually. The most common symptoms of heart failure are shortness of breath, feeling tired, and swelling in the ankles, feet, legs, and sometimes the abdomen. There is no cure for heart failure.
The Advanced Heat Failure Program at UC San Diego Medical Center is dedicated to providing the most beneficial, state-of-the-art, yet cost-effective medical care for patients with advanced heart failure. As part of the Sulpizio Family Cardiovascular Center, patients have access to the newest investigational drugs and devices, cardiac resynchronization therapy, implantable defibrillators, ablation therapy for atrial and ventricular arrhythmias, left ventricular assist devices, and the most advanced cardiac surgical techniques.
Patients interested in enrolling in this clinical trial at UC San Diego Medical Center may call 619-543-7723.
The University of California, San Diego Medical Center is the first hospital in California to enroll patients in a multi-center clinical trial, sponsored by Angioblast Systems Inc., to examine the safety and feasibility of administering adult stems cells to treat congestive heart failure. The cells, derived from bone marrow, are injected by a catheter directly
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An implantable hemodynamic monitor (IHM) may help to guide medical treatment in a large subgroup of patients with heart failure-those with diastolic heart failure (DHF), reports a study in the December Journal of Cardiac Failure, published by Elsevier. Led by Michael R. Zile, M.D., of Medical University of South Carolina, Charleston, the researchers analyzed data
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Researchers at the University of Utah are enrolling people in a new clinical trial that uses a patient’s own stem cells to treat ischemic and non-ischemic heart failure. The one-year Cardiac Repair Cell Treatment of Patients with Dilated Cardiomyopathy (IMPACT-DCM) study will look at the safety of injecting Cardiac Repair Cells (CRC) and their ability
Full Post: Scientists use patient’s own stem cells to treat heart failure
While the treatment of heart failure has improved over the past two decades, a new study reported in the European Journal of Heart Failure finds that “the use of evidence-based treatments appears to be imbalanced according to the gender of the patient”. In particular, the study found that female patients were less frequently treated
Full Post: The drug treatment of heart failure is influenced by the gender of the patient and of the physician
Altus Pharmaceuticals Inc. announced today that it is reaffirming its plan to submit a new drug application (NDA) for Trizytek (liprotamase) in the first-half of 2009. Trizytek is a non-porcine derived enzyme replacement therapy for patients with pancreatic insufficiency. Based on a positive FDA response to Altus’ pre-NDA meeting submission material, Altus and the FDA
Full Post: Altus Pharmaceuticals reaffirms plan to submit NDA for Trizytek