FIRST-EVER GENE THERAPY FOR HEART PATIENTS
Experimental Trial is Underway at Local Hospital

October 5, 2007 - Sharp Memorial Hospital and San Diego Cardiac Center are participating in the first-ever human gene transfer therapy clinical trial in patients with heart failure. Three patients have already been treated at Sharp Memorial since the trial began in May and the trial continues to recruit candidates.

The Phase I clinical trial involves use of a protein package (MYDICAR®) to transport a synthetically produced gene into the heart to stimulate the production of an enzyme that is reduced in patients with moderate to severe heart failure. The protein package containing the heart gene is infused through a small tube into the arteries of the heart during a procedure called cardiac catheterization. The deficient enzyme is SERCA2a protein that acts as a calcium pump in the heart muscle cells, which in turn causes the heart to contract. Malfunction of this pump enzyme is associated with progressive heart failure. The trial was reviewed and approved by the Sharp HealthCare Institutional Review Board.

"Our application of this new therapy to individuals with heart failure represents an extension of work done over many years by basic science researchers. We hope that this therapy will be found effective for our patients," says Brian Jaski, M.D., Medical Director of Advanced Heart Failure and Clinical Cardiology.

The trial by Celladon Corporation, titled "Calcium Up-Regulation by Percutaneous Administration of Gene Therapy In Cardiac Disease (CUPID Trial)," is a Phase I trial designed to investigate the safety, possible harms, and side effects of infusing the experimental gene transfer agent, MYDICAR® into the heart.

The study is being conducted at approximately nine medical centers in the United States. In stage 1, 12 patients are being enrolled and treated with one of four increasing doses of MYDICAR®. The trial is intended to determine what dose might be effective or the highest dose that is safe. During stage 2 of the trial, projected for next year, 33 appropriate patients will be randomized to receive either MYDICAR® or a placebo. Patients will be closely monitored prior to and following the administration of the heart gene therapy by the San Diego Cardiac Center.

Celladon Corporation claims studies in large-animal models of heart failure demonstrated that administration of MYDICAR® led to significant improvements in heart function without significant safety concerns. Gene therapy, however, is experimental and clinical trials conducted to date have not proven it to be safe or effective in humans.

Individuals with heart disease that are interested in the trial should have their physician contact the San Diego Cardiac Center at (858) 244-6890, for more information and to determine if they are a candidate.

About Sharp HealthCare

Consistently ranked as the number-one integrated health care system in Southern California by Modern Healthcare, Sharp HealthCare is San Diego's most comprehensive health care delivery system. It is recognized for clinical excellence for services in cardiac, cancer, and multi-organ transplantation, as well as orthopaedics, rehabilitation, behavioral health and women's health. The Sharp system includes four acute care hospitals, three specialty hospitals, three affiliated medical groups and a health plan. To learn more about Sharp, visit www.sharp.com.