MEDICAL CITY TO PARTICIPATE IN CLINICAL TRIAL FOR BREAKTHROUGH GENE THERAPY PROCEDURE TO TREAT ADVANCED HEART FAILURE

Hospital One of Fifteen in U.S. Selected to Participate; Coinciding with American Heart Month in February, Medical City Recruiting Trial Participants

In support of American Heart Month, Medical City is taking part in an effort to raise awareness about heart disease by participating in an innovative clinical trial for those suffering from advanced heart failure.  Known as CUPID (Calcium Up-Regulation by Percutaneous Administration of Gene Therapy In Cardiac Disease), the trial is the first attempt by doctors to treat advanced heart failure using gene replacement therapy.

The trial is being administered by the Cardiopulmonary Research Science and Technology Institute (CRSTI), a Texas-based clinical research institute devoted to advancing knowledge and therapies for cardiovascular diseases.

The study is evaluating MYDICAR® , a genetically-targeted enzyme replacement therapy for advanced heart failure.  Data collected during Phase 1 of the study demonstrate an acceptable safety profile for patient use, and the ability of MYDICAR to replace a critical enzyme present in normal cardiac muscle cell activity.  Medical City is now enrolling participants for Phase 2 of the clinical trial which compares the use of MYDICAR at higher dose levels in patients.

Dr. Eric J. Eichorn, medical director of CRSTI at Medical City and principal investigator on the CUPID trial, is confident that this specialized genetic therapy will improve the symptoms of heart failure and reverse the severity of the disease.

"The results from Phase 1 of the CUPID trial are very encouraging and suggest that gene therapy for heart failure is within close reach," said Dr. Eichorn.  "We're hopeful that the second phase of this trial replicates the desired results in a greater number of patients to further validate our belief that damaged hearts are capable of recovering lost function.  Ultimately our goal is to bring this exciting new treatment to our patients at Medical City."

On the forefront of cardiovascular technology, Medical City has been recognized for advancements made in robot-assisted microsurgery, beating-heart surgery and minimally invasive heart surgery.  Medical City was selected for the trial because of its experience and success in treating heart disease.  Medical City was previously selected by the FDA as an investigative site in an international trial evaluating the Edwards SAPIEN transcatheter heart valve, developed by Edwards lifesciences, in patients who are considered high-risk or non-operable for conventional open-heart valve surgery.

Researchers expect to enroll five to ten patients with advanced heart failure at the CRSTI facility at Medical City Hospital.  Patients interested in enrolling in the CUPID clinical trial can download a patient questionnaire to review with their physician and determine their eligibility at www.celladon.net , under the "For Patients" tab.  If eligible to participate in the study, patients may call 972-566-4083.

Patients and physicians interested in additional information on MYDICAR and the CUPID trial may visit http://www.clinicaltrials.gov/ct/show/NCT00454818?order=1.