Medicure Announces MEND-CABG II Study Results at the American College of Cardiology Annual Scientific Session
April 01 2008 - 3:35PM
Marketwired
WINNIPEG, MANITOBA (AMEX: MCU), a cardiovascular-focused
biopharmaceutical company, today announced the presentation of its
Phase 3 MEND-CABG II study results at the American College of
Cardiology 57th Annual Scientific Session. The study was designed
to evaluate the effect of Medicure's lead product MC-1, versus
placebo, on the incidence of cardiovascular death or nonfatal
myocardial infarction up to and including 30 days following
coronary artery bypass graft (CABG) surgery. As reported previously
the study did not achieve its primary endpoint.
MEND-CABG II primary endpoint:
- The primary efficacy outcome occurred in 140/1510 (9.3%)
patients in the MC-1 group and 133/1486 (9.0%) patients in the
placebo group (p equals 0.76).
MEND-CABG II other findings:
- Length of hospital stay was similar between MC-1 and placebo
(mean values 7.6 days vs. 7.5 days, p equals 0.14).
- Length of stay in ICU or CCU was similar between MC-1 and
placebo (mean values 2.7 days vs. 2.7 days, p equals 0.58).
- All-cause mortality was higher among patients assigned to MC-1
than placebo at 4 days (1.0% vs. 0.3%, p equals 0.03), but similar
at 30 days (1.9% vs 1.5%, p equals 0.44).
- Overall rates of adverse events and serious adverse events
were similar between patients assigned to receive MC-1 and
placebo.
"We are clearly disappointed in the outcome of MEND-CABG II. The
lack of efficacy with MC-1 and low placebo event rate witnessed in
Phase 3 are very surprising to us given our previous results from
the Phase 2b MEND-CABG study. Nonetheless, based on the Phase 3
results we will not be continuing MC-1's acute clinical development
for CABG or acute coronary syndrome, at this time," commented
Medicure's President and CEO, Albert D. Friesen, PhD. "However, we
believe MC-1 has potential in certain chronic cardiovascular and
metabolic conditions, and are currently exploring development
opportunities in these areas."
"Having been involved in previous reperfusion injury studies, it
appears that this key challenge remains unmet. Although MEND-CABG
II was unsuccessful, I commend the Medicure team and MEND CABG II
investigators for pursuing this important clinical indication and
major medical need," added Dr. Paul Armstrong Professor in the
Department of Medicine, University of Alberta, and Head of
Medicure's Scientific Advisory Board. "Regardless of the outcome of
MEND-CABG II, I believe there may well yet be a potential
application for MC-1 in chronic cardiovascular and metabolic
disease, and look forward to supporting Medicure's endeavors in
this area."
About MEND-CABG II
The pivotal Phase 3 MEND-CABG II trial was a double-blind,
randomized, placebo-controlled clinical trial that enrolled over
3,000 patients undergoing CABG surgery at more than 130 cardiac
surgical centers throughout North America and Europe.
Study patients were randomized to receive placebo or MC-1 250 mg
prior to surgery and for 30 days post operatively (POD 30). The
primary efficacy endpoint of MEND-CABG II was the incidence of
cardiovascular death or non-fatal myocardial infarction up to and
including POD 30. Study patients were followed for 60 days after
treatment (90 days post operatively) for additional safety and
efficacy analysis. The study was initiated in November 2006.
Medicure conducted the MEND-CABG II study in conjunction with
Duke Clinical Research Institute (DCRI) and Montreal Heart
Institute (MHI). Principal investigators for the study are Dr.
Robert Harrington, Director of the DCRI, and Dr. Michel Carrier,
Director of Cardiovascular Surgery Program at MHI.
Dr. Jean-Claude Tardif, Director of the Research Centre, MHI,
and Dr. Robert W. Emery, Jr., Medical Director of Cardiovascular
Services, St Joseph's Hospital, served as co-chairs of the
MEND-CABG II steering committee.
About Medicure Inc.
Medicure Inc is a biopharmaceutical company focused on the
research, development and commercialization of novel compounds to
treat cardiovascular disorders.
Cardiovascular medicine represents the largest pharmaceutical
sector, with annual global sales of over US $70 billion. Medicure
aims to make a global impact on cardiovascular disease and stroke
by reducing deaths, improving the quality of life and serving the
unmet needs of people who suffer from cardiovascular disease and
stroke.
This press release contains forward-looking statements, as
defined under applicable securities legislation, that involve
risks, which may cause actual results to differ materially from the
statements made, and accordingly may be deemed to be
forward-looking statements made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
The forward-looking statements are made as of the date hereof, and
the Company disclaims any intention and has no obligation or
responsibility to update or revise any forward-looking statements,
whether as a result of new information, future events, or otherwise
except as required by law. Such forward-looking statements involve
known and unknown risks, uncertainties and other factors that may
cause the actual results, events or developments to be materially
different from any future results, events or developments expressed
or implied by such forward-looking statements. Such factors
include, among others, the Company's stage of development, lack of
product revenues, additional capital requirements, risks associated
with the completion of clinical trials and obtaining regulatory
approval to market the Company's products, the ability to protect
its intellectual property, dependence on collaborative partners and
the ability to meet its debt obligations. These factors should be
considered carefully and readers are cautioned not to place undue
reliance on such forward-looking statements. Additional risks and
uncertainties relating to the Company and its business can be found
in the "Risk Factors" section of its Form 20F for the year ended
May 31, 2007.
Contacts: Medicure Inc. Derek Reimer Chief Financial Officer
1-888-435-2220 (204) 488-9823 (FAX) Email: info@medicure.com
Website: www.medicure.com
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