Healthcare Industry News: Scios
News Release - November 13, 2006
Scios Announces Selection of Independent Executive Committee and Planned Protocol Design for the ASCEND-HF Landmark International Outcomes Trial of NATRECOR(R) (nesiritide)FREMONT, Calif., Nov. 13 (HSMN NewsFeed) -- 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® 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® 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® 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®, 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® Clinical Development Program
The ASCEND-HF trial is part of Scios' clinical development program for NATRECOR®, 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®," 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®, as well as our unwavering commitment to the heart failure community."
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 1,407 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 Johnson & Johnson. Johnson & Johnson assumes no obligation to update any forward-looking statements as a result of new information or future events or developments.
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