NEWS Oct 16/2001/Phase II infoMedicure's phase II trial to be managed by Duke
Medicure Inc
MPH
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Wednesday Oct 17 2001
News Release
Dr. Albert Friesen reports
Medicure has entered into an agreement with the Duke Clinical Research Institute
to manage its phase II multicentre clinical trial to evaluate the ability of MC-1 to
reduce heart damage in patients who experience ischemia and ischemic
reperfusion injury.
The Duke Clinical Research Institute (DCRI), Durham, N.C., is a world leader in
cardiology clinical trials and clinical drug research. DCRI combines the scientific
thought leadership of Duke University Medical Center with significant outstanding
clinical trials operational capabilities to perform phase II-IV clinical trials and
outcomes research studies.
Medicure's phase II trial is designed to evaluate the cardioprotective activity of
MC-1. Specifically, the trial will quantify the drug's ability to reduce injury
associated with procedures such as angioplasty in which the heart can experience
damage due to the blocking and subsequent resumption of blood flow to a portion
of the heart muscle. The primary end point will be infarct size determined by the
levels of a specific enzyme (CK-MB) released by damaged portions of the heart.
"We are looking forward to carrying out this multicentre clinical study in
cardiovascular patients," said Dr. James E. Tcheng, associate professor of
medicine, Duke University Medical Center, and the principal investigator. "We will
be addressing an important and continuing problem for which there is no
well-established therapy. A product that can successfully demonstrate protection
for our patients in this area would fill a major need and be well received by
practitioners."
DCRI has written the protocol for the trial and Medicure is now preparing
regulatory submissions to the Food and Drug Administration in the United States
and the Therapeutics Products Program (TPP) in Canada for the trial and expects
to file same prior to the end of November, 2001.
"We are pleased to take our lead cardiovascular drug into this study to establish
proof of principle in patients with heart disease," stated Dr. Albert Friesen,
president and chief executive officer, Medicure. "The opportunity to do this trial
with leading clinicians and researchers will be of great value to the company as we
take this important next step in the commercialization of MC-1."
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