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HepC Newsletter
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Dema-@aol.com
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Sep 05, 2009 22:57 PDT
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Medtronic Initiates Phase II Hepatitis C Clinical Study “COPE-HCV” to
Determine Tolerability and Safety of Continuous Interferon Infusion for
Patients with HCV
Medtronic Paradigm® Pump Infusion System and CareLink™ Clinical Monitoring
System Used to Study the Continuous Delivery of INTRON A in Previously
Untreated Genotype 1 Patients
MINNEAPOLIS – Sept. 2, 2009 – 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.
About Medtronic Drug-Device Delivery Innovations
A pioneer of drug delivery systems, Medtronic recently announced new
developments in its long-standing goal to create a “closed-loop” diabetes
management system designed to closely mimic the insulin delivery of a normal
pancreas. In addition, the company provides its SynchroMed® II implantable,
drug infusion system for the treatment of chronic, intractable pain, or to
deliver ITB TherapySM (Intrathecal Baclofen Therapy) to treat severe
spasticity related to brain injury, cerebral palsy, multiple sclerosis, spinal cord
injury, or stroke.
About Hepatitis C
Hepatitis C is a blood-borne liver disease that can lead to chronic liver
disease, liver cancer, cirrhosis, and death. The virus affects an estimated
3.2 million people in the United States alone and some 170 million
worldwide.
About Medtronic
Medtronic, Inc. (_www.medtronic.com_ (http://www.medtronic.com) ),
headquartered in Minneapolis, is the global leader in medical technology –
alleviating pain, restoring health and extending life for millions of people around
the world.
Any forward-looking statements are subject to risks and uncertainties such
as those described in Medtronic’s Annual Report on Form 10-K for the year
ended April 24, 2009. Actual results may differ materially from anticipated
results.
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