�Biogen Idec (Nasdaq: BIIB) announced the initiation of a Phase III clinical trial of intravenous (IV) ADENTRI� (BG9928), an adenosine A1 sense organ antagonist, for acute decompensated heart failure (ADHF) patients with nephritic insufficiency. The trial will evaluate ADENTRI, which is being developed under a licensing agreement with CV Therapeutics (Nasdaq: CVTX), or placebo in addition to standard of care in approximately 900 patients in 21 countries globally, including the United States.
The TRIDENT-1 (TReatment with Intravenous BG9928 for patients with acutely DEcompensated heart failure and reNal insufficiency Trial) study is a Phase III randomised, multi-center, double blind, placebo-controlled, parallel-group study to assess the efficacy and safety of IV ADENTRI dosed up to five-spot days on body weight in ADHF patients with impaired nephritic function. Body weight is a bill of liquid accumulation, which is considered an important cause of symptoms experienced by pump failure patients.
"In previous clinical studies, ADENTRI has exhibited the potential to optimize runny management without harmful personal effects on renal function. Heart failure patients with renal insufficiency ar at danger for poor clinical outcomes and ar among the most difficult to handle, as presently available therapies negatively impingement renal part," said lead investigator William Abraham, M.D., Professor of Internal Medicine and Director of the Division of Cardiovascular Medicine, The Ohio State University Medical Center.
"We ar excited to see ADENTRI enter into Phase III studies as one of Biogen Idec's lead cardiorespiratory programs," said Barry Ticho, M.D., Ph.D., Vice President, Cardiopulmonary and Emerging Therapies, Biogen Idec. "Following lixivaptan, ADENTRI simon Marks the secondment novel compound in Biogen Idec's cardiorespiratory franchise that is in Phase III clinical trials for heart failure patients. We appear forward to advancing this and our other programs in the future."
According to the American Heart Association, spunk failure is the most common causal agent of hospitalizations in the U.S. Studies have shown that more than 60% of patients hospitalized with heart bankruptcy have renal insufficiency, which is an important sovereign determinant of survival and hospitalization in this clinical setting. The effect of renal insufficiency on sharp decompensated heart failure patients is significant as these patients tend to keep back fluid, which causes stress on both the cardiovascular and nephritic systems.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis and rheumy arthritis. For product labeling, press releases and extra information near the company, please visit http://www.biogenidec.com.
Biogen Idec Safe Harbor
This press release contains advanced statements regarding ADENTRI. These statements ar based on Biogen Idec's current beliefs and expectations. The commercial potential of ADENTRI is subject to a number of risks and uncertainties, including the risk of meeting the end points in clinical trials, early unexpected delays or hurdle race, and the uncertainty of obtaining regulative approval. Drug development and commercialization involves a high gear degree of risk.
For more elaborate information on the risks and uncertainties associated with Biogen Idec's drug development and other activities, see Item 1A "Risk Factors" in Biogen Idec's most recent Form 10-Q filing with the Securities and Exchange Commission. These fore looking statements speak only as of the date of this press acquittance, and we assume no obligation to update any forward-looking statements, whether as a result of newfangled information, future events or otherwise.
Biogen Idec Safe Harbor
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