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.