FREMONT, Calif., Sept. 7 /PRNewswire-FirstCall/ -- Scios Inc. announced the selection of Duke Clinical Research Institute (DCRI) as the independent academic research organization that will lead the ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) trial. This independent, global, multi-center outcomes study of approximately 7,000 patients will further assess the benefit and safety profile of NATRECOR® in patients with acutely decompensated heart failure (ADHF). Robert M. Califf, M.D., Director of DCRI, will serve as chair of the trial. DCRI, the clinical research organization within Duke University Medical Center, will collaborate with the Cleveland Clinic Cardiovascular Coordinating Center (C5) in managing the trial, and other leading medical centers around the world will participate. Patient enrollment for ASCEND-HF is expected to begin in the first half of 2007.
"ADHF is a global epidemic, leading to as many deaths as acute heart attacks, but with few defined effective treatments. The ASCEND-HF trial will add to the growing body of evidence and will provide important clinical data about the impact of NATRECOR® on outcomes that matter: most importantly, symptom relief, readmission to the hospital for heart failure and death," 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. "We are also very pleased and honored that Scios has chosen us to lead a global consortium of academic leaders who will conduct the study with the type of independence that is required to provide confidence to the clinical community and the public in the results of the trial."
The ASCEND-HF trial is part of Scios' robust clinical development program, in which the company continues to evaluate the efficacy, clinical benefits and safety profile of NATRECOR® in ongoing clinical trials, designed to study its impact on mortality, as well as kidney and lung function.
ASCEND-HF Trial Details
The randomized, double-blind, placebo-controlled trial will enroll approximately 7,000 patients with ADHF and will be conducted at approximately 600 sites globally. The study will evaluate NATRECOR® administered at the currently recommended dose of an intravenous (IV) bolus of 2 mcg/kg followed by a continuous infusion of 0.010 mcg/kg/minute.
Clinical endpoints may include symptom relief, quality of life, rehospitalization for heart failure and mortality. The study will have adequate power to provide clinical confidence about the effect of NATRECOR® on mortality in this population, as well as other important outcomes data. The independent executive committee for the ASCEND-HF study will be disclosed as the committee becomes finalized. The committee will define the final protocol and clinical endpoints for the trial.
"As part of Scios' commitment to advancing the treatment of ADHF, this study will join two of the largest, most experienced academic clinical research organizations in the world to collaborate with other medical centers globally on this unprecedented trial in patients with ADHF," said Roger Mills, M.D., Vice President, Medical Affairs at Scios Inc. "We are confident that we will obtain additional data that will go beyond our current efficacy data showing improvement of patient-reported dyspnea and improvement of pulmonary wedge pressures. These important outcomes data will further elucidate the benefits of NATRECOR® in the treatment of ADHF."
About Heart Failure
Heart failure affects nearly 5 million Americans and is the most frequent cause of hospital admission for 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 or ovarian cancer.
About NATRECOR® (nesiritide)
NATRECOR® 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® has been studied in 15 clinical trials involving 1,395 patients treated with the drug, and has been used to treat thousands of acutely decompensated heart failure patients.
NATRECOR® 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® reduced pulmonary capillary wedge pressure and improved patient reported dyspnea. For full Prescribing Information, visit www.natrecor.com . 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 www.sciosinc.com .
IMPORTANT SAFETY INFORMATION
NATRECOR® (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® the dose should be reduced or discontinued. At the recommended dose of NATRECOR®, 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® may be prolonged. The mean duration of symptomatic hypotension was longer with NATRECOR® than IV nitroglycerin (2.2 versus 0.7 hours, respectively). NATRECOR® 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® should be used cautiously in these patients. In earlier trials, when NATRECOR® was initiated at doses higher than the 2 mcg/kg bolus followed by a 0.010 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® is not recommended for patients for whom vasodilating agents are not appropriate and should be avoided in patients with low cardiac filling pressures.
NATRECOR® 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® 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® and nitroglycerin groups, respectively. When NATRECOR® was initiated at doses higher than 0.010 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.
In seven NATRECOR® clinical trials, through 30 days, 5.3% in the NATRECOR® 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® 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®. See full Prescribing Information at 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 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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