- Landmark Trial Will Be Largest, Most Comprehensive Acute Heart Failure
Study Conducted to Date -
FREMONT, Calif., June 1 /PRNewswire/ -- Scios Inc. today announced an
international outcomes study involving as many as 7,000 patients designed
to further assess the benefits and safety profile of NATRECOR(R) in
patients with acutely decompensated heart failure. The company plans to
make a significant investment to conduct the trial, which is one component
of a comprehensive clinical development plan for NATRECOR(R). When
completed, the outcomes study will be the largest and most comprehensive
study of its kind, helping to advance knowledge about a large and
critically ill patient population.
"With this landmark trial, we are fulfilling our commitment to do a
large outcomes study following the recommendations of an expert panel,"
said Roger Mills, M.D., Vice President, Medical Affairs at Scios. "This
trial underscores our confidence in the safety and efficacy of NATRECOR(R)
as a treatment for acutely decompensated heart failure and reflects a major
commitment to heart failure patients and the doctors, nurses and
pharmacists who help treat these patients. "We believe this study will
deliver timely, thorough and meaningful data regarding the safety and
efficacy of NATRECOR(R), and more clearly define the benefit/risk ratio."
In June 2005, Scios brought together an expert panel of cardiology and
heart failure clinicians to provide recommendations regarding NATRECOR(R).
Chaired by Eugene Braunwald, M.D., Distinguished Hersey Professor of
Medicine at Harvard Medical School and Chairman of the TIMI Study Group at
Brigham and Women's Hospital in Boston, the panel assessed important data
associated with NATRECOR(R) and provided guidance and counsel on the
ongoing and planned clinical development program for the product, as well
as offering recommendations for use. The panel endorsed Scios' plan to
conduct several trials, including a large trial of clinical outcomes. In
the period since the expert panel provided its recommendations, Scios has
been actively exploring a broad range of trial design options that would
meet the goals identified by the panel, as well as other critical goals to
further advance knowledge of heart failure.
"I am pleased that Scios is following through on the panel
recommendations with such an ambitious trial that will help us learn more
about the optimal treatment of acute heart failure, a large unmet medical
need that is not adequately served," said Dr. Braunwald.
Heart failure affects nearly 5 million Americans and is the most
frequent cause of hospitalization in patients over 65 years of age. With
550,000 new cases each year, the number of new heart failure cases exceeds
those of AIDS, breast cancer or Alzheimer's disease. Acute heart failure
results in nearly 1 million hospitalizations annually -- more than the
number of patients hospitalized for heart attack -- and is responsible for
more annual deaths than leukemia, breast, pancreatic and ovarian cancers.
NATRECOR(R) with standard therapy is the only approved treatment for
acutely decompensated heart failure that has demonstrated in controlled
clinical trials the clinical benefit of improvement of dyspnea and
reduction of filling pressure. NATRECOR(R) has been widely studied in a
comprehensive clinical program. To date, it has been studied in 1,529
patients in 14 clinical trials, and additional clinical trials are under
way or planned that will collect further data related to mortality and the
renal impact of NATRECOR(R).
Study Details
The trial will be conducted at centers in the United States, Canada and
Europe and involve as many as 7,000 patients with acutely decompensated
heart failure. It will evaluate improvement in dyspnea (shortness of
breath), rehospitalization, mortality, renal effects, quality of life and
pharmacoeconomics.
Patient enrollment is expected to begin in the first quarter of 2007.
In the coming months, Scios will finalize and announce the independent
academic research organization that will oversee and execute the trial,
including a study chair, principal investigators, DSMB and steering
committee. In addition, the company will hold discussions with regulatory
authorities about the proposed clinical development plan.
"Acutely decompensated heart failure patients are typically critically
ill and often have co-morbidities. Consequently, many considerations were
taken into account, including gathering diverse input from heart failure
thoughtleaders, reviewing recently conducted clinical trials and assessing
guidance from a broad range of regulatory authorities," added Dr. Mills.
"This led to our decision to embark upon what will be a landmark trial in
the field of acutely decompensated heart failure. Patient safety is our
priority, and we are confident that data generated from this study will
advance our understanding of the treatment of patients with acutely
decompensated heart failure."
About NATRECOR(R) (nesiritide)
NATRECOR(R) is indicated for the intravenous treatment of patients with
acutely decompensated congestive heart failure who have dyspnea at rest or
with minimal activity. In this population, the use of NATRECOR(R) reduced
pulmonary capillary wedge pressure and improved dyspnea. For full
Prescribing Information, visit http://www.natrecor.com.
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 http://www.sciosinc.com.
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 <90 mm Hg or as primary therapy in patients with
cardiogenic shock. The rate of symptomatic hypotension may be increased
with a baseline blood pressure <100 mm Hg, and NATRECOR(R) should be used
cautiously in these patients. In earlier trials, when NATRECOR(R) was
initiated at doses higher than the 2 mcg/kg bolus followed by a 0.01
mcg/kg/min infusion, the frequency, duration, and intensity of hypotension
was increased. The hypotensive episodes were also more often symptomatic
and/or more likely to require medical intervention. NATRECOR(R) is not
recommended for patients for whom vasodilating agents are not appropriate
and should be avoided in patients with low cardiac filling pressures.
RENAL
NATRECOR(R) may affect renal function in susceptible individuals. In
patients with severe heart failure whose renal function may depend on the
activity of the renin-angiotensin-aldosterone system, treatment with
NATRECOR(R) may be associated with azotemia. In the VMAC trial, through day
30, the incidence of elevations in creatinine to >0.5 mg/dL above baseline
was 28% and 21% in the NATRECOR(R) and nitroglycerin groups, respectively.
When NATRECOR(R) was initiated at doses higher than 0.01 mcg/kg/min, there
was an increased rate of elevated serum creatinine over baseline compared
with standard therapies, although the rate of acute renal failure and need
for dialysis was not increased.
MORTALITY
In seven NATRECOR(R) clinical trials, through 30 days, 5.3% in the
NATRECOR(R) treatment group died as compared with 4.3% in the group treated
with other standard medications. In four clinical trials, through 180 days,
21.7% in the NATRECOR(R) treatment group died as compared with 21.5% in the
group treated with other medications. There is not enough information to
know if there is an increased risk of death after treatment with
NATRECOR(R).
See full Prescribing Information at http://www.natrecor.com.
This press release contains "forward-looking statements" as defined in
the Private Securities Litigation Reform Act of 1995. These statements are
based on current expectations of future events. If underlying assumptions
prove inaccurate or unknown risks or uncertainties materialize, actual
results could vary materially from Johnson & Johnson 's expectations and
projections. Risks and uncertainties include general industry conditions
and competition; economic conditions, such as interest rate and currency
exchange rate fluctuations; technological advances and patents attained by
competitors; challenges inherent in new product development, including
obtaining regulatory approvals; domestic and foreign health care reforms
and governmental laws and regulations; and trends toward health care cost
containment. A further list and description of these risks, uncertainties
and other factors can be found in Exhibit 99 of Johnson & Johnson 's Annual
Report on Form 10-K for the fiscal year ended January 1, 2006. Copies of
this Form 10-K, as well as subsequent filings, are available online at
http://www.sec.gov or on request from the Johnson & Johnson. Johnson & Johnson
assumes no obligation to update any forward-looking statements as a result
of new information or future events or developments.
SOURCE Scios Inc.
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Related links:
http://www.natrecor.com/
http://www.sciosinc.com/
CONTACT:
Chris Ernst of Scios Inc., +1-510-248-2819,
or cell, +1-415-710-9445, or cernst1@scius.jnj.com
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