Scios Inc. today announced the
13 heart failure experts from North America and Europe who will serve on
the independent executive committee that will lead the ASCEND-HF (Acute
Study of Clinical Effectiveness of Nesiritide in Decompensated Heart
Failure) trial. Scios also described the general design features of the
protocol for this global, multi-center outcomes study of approximately
7,000 patients.
ASCEND-HF, the largest trial ever planned in the acute heart failure
field, is being conducted to further assess important clinical outcomes as
well as the benefit and safety profile of NATRECOR(R) in patients with
acutely decompensated heart failure (ADHF).
Robert M. Califf, M.D., Director of the Duke Translational Medicine
Institute (DTMI), will chair the trial. The Duke Clinical Research
Institute (DCRI), the academic clinical research organization within the
DTMI at Duke University Medical Center, will collaborate with the Cleveland
Clinic Cardiovascular Coordinating Center (C5) in managing the trial. In
addition to Dr. Califf, the members of the ASCEND-HF executive committee
include:
-- Paul W. Armstrong, M.D., Professor of Medicine and Director of the
Canadian VIGOUR Centre at the University of Alberta in Edmonton,
Alberta, Canada
-- Henry Dargie, M.D., Professor, Department of Cardiovascular Medicine at
the Gardiner Institute in Glasgow, Scotland
-- Kenneth Dickstein, M.D., Ph.D., Professor, Institutt for Indremedisin,
University of Bergen, Central Hospital in Rogaland, Bergen, Norway
-- Michel Komajda, M.D., Professor, Pitie Salpetriere Hospital and
University Pierre et Marie Curie in Paris, France
-- Barry Massie, M.D., Chief, Cardiology Section, VA Medical Center, San
Francisco
-- Prof. John J.V. McMurray, Professor of Medical Cardiology, University
of Glasgow, Scotland
-- Markku S Nieminen, M.D., Professor, Chief, Department of Medicine,
Helsinki University Central Hospital in Helsinki, Finland
-- Christopher O'Connor, M.D., Director, Duke Heart Failure Program,
Professor of Medicine in the Division of Cardiology, Chief of Clinical
Pharmacology at Duke University Medical Center
-- Marc A. Pfeffer, M.D., Ph.D., Professor, Senior Physician in Cardiology
at Brigham and Women's Hospital in Boston
-- Jean-Lucien Rouleau, M.D., Professor, Dean of the Faculty of Medicine
at the Universite de Montreal-Pavillon in Montreal, Canada
-- Randall C. Starling, MD, MPH, FACC, Professor of Medicine, Vice
Chairman of the Department of Cardiovascular Medicine, Section Head,
Heart Failure & Cardiac Transplant Medicine at the Cleveland Clinic
-- Karl Swedberg M.D., Ph.D., Professor of Medicine at Sahlgrenska
University Hospital/Ostra, The Sahlgrenska Academy at Goteborg
University in Goteborg, Sweden
"Patients with ADHF are critically ill, and their plight has not been
addressed adequately by the clinical research community. The ASCEND-HF
trial will provide clinical data about the impact of NATRECOR(R) on
important clinical outcomes for patients with ADHF, including symptom
relief, readmission to the hospital for heart failure and mortality," said
Dr. Califf, who is also Vice Chancellor for Clinical Research and Professor
of Medicine in the Division of Cardiology at Duke University Medical
Center. "The trial is being led by a stellar group of thought-leading
cardiologists and experienced investigators who have been instrumental in
guiding cardiovascular clinical practice. I am confident that this
independent group of seasoned professionals will conduct the trial with the
highest standards and provide important information about the treatment of
ADHF."
ASCEND-HF Planned Protocol Design and Clinical Endpoints
In this randomized, double-blind, placebo-controlled, parallel-group,
multicenter trial, approximately 7,000 patients with ADHF will be
randomized to receive NATRECOR(R) at the indicated dose or placebo for a
minimum of 24 hours up to a maximum of seven days, in addition to standard
care. The trial will be conducted at approximately 600 sites, including
leading medical centers around the world. Patient enrollment is expected to
begin in the first half of 2007.
The trial's key efficacy objectives are to assess whether NATRECOR(R),
in addition to standard care, compared with placebo and standard care,
provides significant improvement in symptom relief, heart failure
rehospitalization, and mortality after admission to the hospital.
Other important clinical endpoints will also be evaluated, including
safety, renal function and health economics.
Discussions are planned with the appropriate regulatory authorities to
gain their feedback before finalization of this protocol design.
NATRECOR(R) Clinical Development Program
The ASCEND-HF trial is part of Scios' clinical development program for
NATRECOR(R), as the company continues to evaluate the efficacy, clinical
benefits and safety profile of the drug in ongoing clinical trials.
"The selection of the executive committee for ASCEND-HF marks a major
milestone toward expanding the base of knowledge about NATRECOR(R)," said
Roger Mills, M.D., Vice President, Medical Affairs at Scios. "This critical
study is a key component of our robust clinical development program and
demonstrates our confidence in the efficacy and safety of NATRECOR(R), as
well as our unwavering commitment to the heart failure community."
About NATRECOR(R) (nesiritide)
NATRECOR(R) added to standard therapy is the only approved treatment
for ADHF that has shown improvement in difficulty breathing and reduction
of elevated wedge pressures in the lungs in controlled clinical trials.
NATRECOR(R) has been studied in 15 clinical trials involving 1,407 patients
treated with the drug, and has been used to treat thousands of acutely
decompensated heart failure patients.
NATRECOR(R) is indicated for the intravenous treatment of patients with
ADHF who have dyspnea at rest or with minimal activity. In this population,
the use of NATRECOR(R) reduced pulmonary capillary wedge pressure and
improved patient reported dyspnea. For full Prescribing Information, visit
natrecor. See Important Safety Information below.
About Scios Inc.
Scios Inc., a Johnson & Johnson company, is a biopharmaceutical company
headquartered in Fremont, California. Scios is developing novel treatments
for cardiovascular disease, inflammatory disease and cancer. The company's
disease-based technology platform integrates expertise in protein biology
with computational and medicinal chemistry to identify novel targets and
rationally design small molecule compounds and peptides for markets with
unmet medical needs. For more information, visit sciosinc.
IMPORTANT SAFETY INFORMATION
HYPOTENSION
NATRECOR(R) (nesiritide) may cause hypotension and should be
administered only in settings where blood pressure can be monitored
closely. If hypotension occurs during administration of NATRECOR(R) the
dose should be reduced or discontinued. At the recommended dose of
NATRECOR(R), the incidence of symptomatic hypotension (4%) was similar to
that of IV nitroglycerin (5%). Asymptomatic hypotension occurred in 8% of
patients treated with either drug. In some cases, hypotension that occurs
with NATRECOR(R) may be prolonged. The mean duration of symptomatic
hypotension was longer with NATRECOR(R) than IV nitroglycerin (2.2 versus
0.7 hours, respectively). NATRECOR(R) should not be used in patients with
systolic blood pressure