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CRSTI and Medical City Hospital Dallas Currently Recruiting For a Phase 2 Clinical Trial of MYDICAR(R) for Advanced Heart Failure
Date:12/15/2008

DALLAS, Dec. 15 /PRNewswire/ -- The Cardiopulmonary Research Science and Technology Institute (CRSTI), and Medical City Hospital, are currently enrolling patients for a Phase 2 clinical trial for advanced heart failure, "Calcium Up-Regulation by Percutaneous Administration of Gene Therapy in Cardiac Disease" (CUPID Trial) for which the initial data were reported recently at the American Heart Association Scientific Sessions 2008. The study is evaluating MYDICAR(R), a genetically-targeted enzyme replacement therapy for advanced heart failure.

"The CUPID trial is designed to rescue a failing heart by replacing an enzyme known to play a critical role in normal cardiac muscle cell activity. Our goal is not only to improve the symptoms of heart failure, but restore physiologic function and reverse the severity of the disease," said Eric J. Eichhorn, MD, FACC, an interventional cardiologist with The Dallas Heart Group who works with Cardiopulmonary Research Science and Technology Institute, and is the principal investigator on the study at Medical City Dallas. "The recent data reported from the study demonstrate the safety of MYDICAR, and improvements in cardiac function and overall condition observed in some patients further validate our target and approach. Given these early encouraging results, we have begun enrollment of phase 2 clinical testing to evaluate the ability of MYDICAR to improve heart function in more patients."

The Phase 2 portion is a randomized, double-blind, placebo-controlled, parallel-group, dose ranging trial that compares the use of MYDICAR at two or three dose levels with placebo. CUPID is expected to enroll 46 patients with advanced heart failure at 15 U.S. medical centers. MYDICAR is delivered in a single dose directly to the heart muscle during a short outpatient procedure, performed in a standard cardiac catheterization laboratory via a small incision in the upper leg.

For patients with heart failure and physicians interested in additional information on MYDICAR and the CUPID Trial, please visit: http://www.clinicaltrials.gov/ct/show/NCT00454818?order=1.

Patients may assess eligibility to participate in the CUPID trial and download a patient questionnaire and additional information to review with your physician by visiting http://www.celladon.net, under the "For Patients" tab.

Patients interested in enrolling in this clinical trial at the Cardiopulmonary Research Science and Technology Institute (CRSTI), Medical City Hospital may call 972-566-4083.

Study Results Presented at the American Heart Association Scientific Sessions

Data from the Phase I in advanced heart failure was presented, and demonstrated that MYDICAR had an acceptable safety profile in these first nine patients, as determined by study investigators and an independent safety committee. In addition, improvements from baseline to six months across a number of parameters important in assessing heart failure status were observed, including symptomatic (5 patients), functional (4 patients), biomarker (2 patients) and left ventricular function/remodeling (6 patients). Of the nine patients treated, two with low levels of pre-existing antibodies to the AAV vector did not show improvement in these parameters.

The data are consistent with safety established for other AAV vectors, which has been demonstrated in clinical studies of more than 500 patients. AAV vectors are the product of decades of research focused on the safety of gene transfer agents, and are derived from components of a non-replicating, non-pathogenic, commonly occurring human virus. AAV vectors do not integrate into the chromosome and are considered non-mutagenic. In addition, they have not been associated with the types of inflammatory reactions observed in trials involving adenoviral vectors, which are known to induce acute inflammation of tissues due to activation of the body's immune system.

About Heart Failure

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 pharmacologic and device therapies, the prognosis of heart failure patients remains poor. Access to nonpharmacologic therapies, such as heart transplantation and the use of mechanical assist devices, is restricted to a fraction of patients who need them. 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.

About CRSTI

The Cardiopulmonary Research Science and Technology Institute (CRSTI) is a not for profit 501(c)(3) organization that was created by local physicians whose mission is to foster and promote the medical research and education that benefits the health of the community and to facilitate the physicians' ability to deliver state-of-the-art medical care, access new therapies, and improve quality clinical outcomes. As cardiovascular diseases continue to be the leading cause of death and disability in America, the institute is devoted to advancing knowledge and therapies for these disorders. CRSTI offers access to a large cardiovascular physician bases along with the critical thinking of leading clinical practitioners.

About Medical City Hospital

Medical City was established in 1974 by a group of North Texas' premiere medical specialists as a new kind of healthcare facility. We continue to attract physicians who are national and international leaders in their specialties and a dedicated staff to support their efforts. Over 1,150 physicians practice more than 95 medical specialties at Medical City. Patients have come from all over the United States and 75 foreign countries to receive healthcare that is recognized on local, national and international levels.


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SOURCE The Cardiopulmonary Research Science and Technology Institute
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