Medtronic's COPE-HCV clinical study commences

Medtronic, Inc. (NYSE: MDT), today reported the initiation and first enrollments of patients in COPE-HCV (COntinuous Interferon Delivery via the Medtronic Paradigm Pump Infusion System Clinical Evaluation for Chronic HCV), the company’s first-ever clinical study using an external pump infusion system to treat patients with the hepatitis C virus (HCV). The COPE-HCV trial is being conducted under an Investigational New Drug Application (IND).

COPE-HCV is a Phase II, 250-plus patient study designed to gather clinical data on the tolerability, safety and efficacy associated with continuous subcutaneous interferon infusion compared with the current standard-of-care in patients with HCV genotype 1 infection not previously treated. In the first month of the U.S. study, 20 patients have been enrolled at six clinical sites in Nashville, Minneapolis, Atlanta, San Antonio, and Sarasota, Fla. Stage 1 of this randomized controlled study will include 124 patients at up to 30 sites.

“For years Medtronic has developed drug-delivery systems to bypass traditional but less effective routes of administration and to help patients with chronic diseases better manage their conditions,” said Bill Hawkins, Medtronic chairman and CEO. “With this trial now underway, we have the potential to extend our pump technologies and develop yet another drug-delivery option for a chronic disease that impacts millions of lives. If successful, this novel therapy will open new doors to treating other advanced diseases more safely and effectively than currently available approaches.”

The World Health Organization has estimated that three to four million people become infected by HCV each year and 70 percent of those infected will develop chronic hepatitis. Standard-of-care for HCV is weekly injections of pegylated interferon in combination with oral ribavirin medication for up to 48 weeks. This therapy is only effective in treating approximately 43 percent of all genotype 1 patients, who represent the overwhelming majority of U.S. hepatitis C cases. In addition, many patients develop serious side effects from weekly injections, including chronic fatigue, depression, blood disorders, and flu-like symptoms.

“There are a host of challenges related to the treatment of HCV that, to this point, have resulted in less than optimal outcomes and therefore patients are at a greater risk for developing progressive liver disease,” said Dr. John McHutchison, associate director of the Duke Clinical University Research Institute (DCRI) and lead investigator of the Medtronic-sponsored study. “However, the innovative strategy that will be studied in the COPE HCV study may ultimately be shown to improve both efficacy and tolerability over currently available drug formulations.”

The COPE-HCV study uses the Medtronic Paradigm Infusion System, a device currently approved by the U.S. Food and Drug Administration for delivering insulin in patients with diabetes. It also incorporates the use of Medtronic’s CareLink remote data management system to ensure patients enrolled in the study are compliant to study protocol for the trial period. The COPE-HCV study will deliver INTRON® A, via the Paradigm pump in combination with oral REBETOL®. The comparison group in the study will use PegIntron™ and REBETOL. All drugs in the trial are manufactured and marketed by Schering-Plough.

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