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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

Monday, December 15, 2008 General News J E 4
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DALLAS, Dec. 15 The Cardiopulmonary Research Scienceand Technology Institute (CRSTI), and Medical City Hospital, arecurrently enrolling patients for a Phase 2 clinical trial for advancedheart failure, "Calcium Up-Regulation by Percutaneous Administration ofGene Therapy in Cardiac Disease" (CUPID Trial) for which the initial datawere reported recently at the American Heart Association ScientificSessions 2008. The study is evaluating MYDICAR(R), a genetically-targetedenzyme replacement therapy for advanced heart failure.

"The CUPID trial is designed to rescue a failing heart by replacingan enzyme known to play a critical role in normal cardiac muscle cellactivity. Our goal is not only to improve the symptoms of heart failure,but restore physiologic function and reverse the severity of thedisease," said Eric J. Eichhorn, MD, FACC, an interventional cardiologistwith The Dallas Heart Group who works with Cardiopulmonary ResearchScience and Technology Institute, and is the principal investigator onthe study at Medical City Dallas. "The recent data reported from thestudy demonstrate the safety of MYDICAR, and improvements in cardiacfunction and overall condition observed in some patients further validateour target and approach. Given these early encouraging results, we havebegun enrollment of phase 2 clinical testing to evaluate the ability ofMYDICAR 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 theuse of MYDICAR at two or three dose levels with placebo. CUPID isexpected to enroll 46 patients with advanced heart failure at 15 U.S.medical centers. MYDICAR is delivered in a single dose directly to theheart muscle during a short outpatient procedure, performed in a standardcardiac catheterization laboratory via a small incision in the upper leg.

For patients with heart failure and physicians interested inadditional 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 anddownload a patient questionnaire and additional information to reviewwith your physician by visiting http://www.celladon.net, under the "ForPatients" tab.

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

Study Results Presented at the American Heart Association ScientificSessions

Data from the Phase I in advanced heart failure was presented, anddemonstrated that MYDICAR had an acceptable safety profile in these firstnine patients, as determined by study investigators and an independentsafety committee. In addition, improvements from baseline to six monthsacross a number of parameters important in assessing heart failure statuswere observed, including symptomatic (5 patients), functional (4patients), biomarker (2 patients) and left ventricularfunction/remodeling (6 patients). Of the nine patients treated, two withlow levels of pre-existing antibodies to the AAV vector did not showimprovement in these parameters.

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

About Heart Failure

Heart failure is the leading medical cause of hospitalization and isexpected to result in estimated direct and indirect costs to thehealthcare system in 2008 of $35 billion. Despite important therapeuticadvances in pharmacologic and device therapies, the prognosis of heartfailure patients remains poor. Access to nonpharmacologic therapies, suchas heart transplantation and the use of mechanical assist devices, isrestricted to a fraction of patients who need them. About 5 millionpeople in the United States have heart failure, and another 550,000 newcases are diagnosed each year. Heart failure contributes to or causesabout 280,000 deaths annually. The most common symptoms of heart failureare 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 localphysicians whose mission is to foster and promote the medical researchand education that benefits the health of the community and to facilitatethe physicians' ability to deliver state-of-the-art medical care, accessnew therapies, and improve quality clinical outcomes. As cardiovasculardiseases continue to be the leading cause of death and disability inAmerica, the institute is devoted to advancing knowledge and therapiesfor these disorders. CRSTI offers access to a large cardiovascularphysician bases along with the critical thinking of leading clinicalpractitioners.

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. Wecontinue to attract physicians who are national and international leadersin their specialties and a dedicated staff to support their efforts. Over1,150 physicians practice more than 95 medical specialties at MedicalCity. Patients have come from all over the United States and 75 foreigncountries to receive healthcare that is recognized on local, national andinternational levels.

SOURCE The Cardiopulmonary Research Science and Technology Institute
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