Aderis Pharmaceuticals' Phase II Atrial Fibrillation Data Accepted for American Heart Association 2003 Scientific Sessions.Business Editors/Health/Medical Writers BIOWIRE2K American Heart Association's 2003 Scientific Sessions HOPKINTON, Mass.--(BUSINESS WIRE)--Aug. 20, 2003 Aderis Pharmaceuticals announced today that data from a Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II of selodenoson (formerly DTI-0009) for the treatment of atrial fibrillation atrial fibrillation Irregular rhythm (arrhythmia) of contraction of the atria (upper heart chambers). The most common major arrhythmia, it may result as a consequence of increased fibrous tissue in the aging heart, of heart disease, or in association with severe infection. will be presented at the American Heart Association's 2003 Scientific Sessions. Selodenoson is a selective adenosine adenosine /aden·o·sine/ (ah-den´o-sen) a purine nucleoside consisting of adenine and ribose; a component of RNA. It is also a cardiac depressant and vasodilator used as an antiarrhythmic and as an adjunct in myocardial perfusion imaging A1 receptor agonist being developed in conjunction with Fujisawa Healthcare, Inc. as an agent to control heart rate during atrial fibrillation. Atrial fibrillation is a common arrhythmia arrhythmia (ārĭth`mēə), disturbance in the rate or rhythm of the heartbeat. Various arrhythmias can be symptoms of serious heart disorders; however, they are usually of no medical significance except in the presence of that can result in an abnormally fast heart rate. This condition affects more than 2 million Americans and 6 million people worldwide. "We are excited about the opportunity to present our Phase II selodenoson data during this international conference," said William Wheeler, M.D., FACC FACC Fellow, American College of Cardiology , Vice President and Chief Medical Officer of Aderis Pharmaceuticals. "We are pleased with selodenoson's progress in clinical trials, as well as the recent progress of our other late-stage development programs. These programs include rotigotine-CDS, partnered with Schwarz Pharma AG, which is completing Phase III trials for Parkinson's disease Parkinson's disease or Parkinsonism, degenerative brain disorder first described by the English surgeon James Parkinson in 1817. When there is no known cause, the disease usually appears after age 40 and is referred to as Parkinson's disease. and is in Phase IIb trials for Restless Legs Syndrome Restless Legs Syndrome Definition Restless legs syndrome (RLS) is characterized by unpleasant sensations in the limbs, usually the legs, that occur at rest or before sleep and are relieved by activity such as walking. . In addition, binodenoson recently completed Phase II trials as a pharmacologic stress agent for the diagnosis of coronary artery disease coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue. and is partnered with King Pharmaceuticals." The abstract, entitled "Intravenous Selodenoson (Formerly DTI-0009), A Novel Adenosine A1 Agonist, Acutely Controls Ventricular Rate in Atrial Fibrillation Without Significant Hemodynamic he·mo·dy·nam·ics n. (used with a sing. verb) The study of the forces involved in the circulation of blood. he Consequences," will be presented by Brent T. McLaurin, M.D., of Carolina Cardiology Consultants on Monday, November 10, 2003 at 3:00 PM (EST EST electroshock therapy. EST abbr. electroshock therapy ). The American Heart Association's Scientific Sessions is the world's largest gathering of scientists and healthcare professionals dedicated to the study and treatment of cardiovascular disease Cardiovascular disease Disease that affects the heart and blood vessels. Mentioned in: Lipoproteins Test cardiovascular disease and stroke. The 2003 convention will take place November 9-12 in Orlando, Florida. Selodenoson, an adenosine A1 agonist, is being developed as an intravenous formulation for the acute treatment of atrial fibrillation in a hospital setting, as well as an oral formulation for chronic management of the disease. Using its small molecule development expertise, Aderis Pharmaceuticals designed selodenoson to control heart rate through selective adenosine A1 receptor stimulation. Selodenoson reduces heart rate in patients without lowering blood pressure, a common complication with current rate control treatments. Aderis licensed to Fujisawa the U.S. and Canadian development and commercialization rights to intravenous selodenoson. In March 2003, Aderis announced the receipt of a $2 million milestone payment from Fujisawa in connection with the completion of an earlier Phase II intravenous selodenoson clinical trial done by Fujisawa. Background: Atrial fibrillation is the most common sustained arrhythmia and is increasing in incidence due to both an aging population and an increase in patients with underlying conditions that can predispose pre·dis·pose v. To make susceptible, as to a disease. them to atrial fibrillation, such as congestive heart failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time. . Atrial fibrillation results in rapid and irregular heart rates of up to 120-180 beats/minute -- 2 to 3 times faster than a normally functioning heart. At this rate, the heart cannot effectively pump blood to the rest of the body, causing symptoms ranging from shortness of breath Shortness of Breath Definition Shortness of breath, or dyspnea, is a feeling of difficult or labored breathing that is out of proportion to the patient's level of physical activity. to heart failure. About Aderis Pharmaceuticals Aderis Pharmaceuticals is a private, biopharmaceutical company engaged in small molecule drug development to treat central nervous system, cardiovascular and inflammatory conditions. The Company's product pipeline includes small molecule, receptor agonists and antagonists for the treatment of Parkinson's disease, Restless Legs Syndrome, atrial fibrillation, diabetic foot diabetic foot A foot with a constellation of pathologic changes affecting the lower extremity in diabetics, often leading to amputation and/or death due to complications; the common initial lesion leading to amputation is a nonhealing skin ulcer, induced by ulcers, the diagnosis and prognosis of coronary artery disease, and other cardiovascular and inflammatory conditions. Aderis and its partners currently have four product candidates in development for six indications. Aderis Pharmaceuticals has a strategic alliance with Schwarz Pharma AG, for the development and commercialization of rotigotine-CDS, a proprietary dopamine agonist formulated as a once-a-day, continuous delivery, transdermal patch. Rotigotine-CDS is currently completing Phase III clinical trials for Parkinson's disease and is in a Phase IIb clinical trial for the treatment of Restless Legs Syndrome. The Company also has alliances with Fujisawa Healthcare, Inc. and King Pharmaceuticals. Founded in 1994, Aderis Pharmaceuticals is headquartered in Hopkinton, Massachusetts and has research facilities in Richmond, Virginia. Certain statements in this news release that are not historical fact constitute "forward-looking statements." Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results of Aderis Pharmaceuticals to be materially different from historical results or from any results expressed or implied by such forward-looking statements. Such statements include, but are not limited to, any statements relating to the Company's development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties, including but not limited to, those risks and uncertainties relating to difficulties or delays in development, testing, regulatory approval, production and marketing of the Company's drug candidates; unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug candidates that could slow or prevent product development or commercialization; the uncertainty of patent protection for the Company's intellectual property or trade secrets; and the Company's ability to obtain additional financing if necessary. Such statements are based on management's current expectations, but actual results may differ materially due to various factors, some but not all of which may have been mentioned above. |
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