HOPKINTON, Mass.--(BUSINESS WIRE)--Nov. 10, 2003--Aderis Pharmaceuticals announced today that Brent McLaurin, M.D., FACC, of Carolina Cardiology Consultants, today presented positive results of a Phase II trial of Aderis Pharmaceuticals' selodenoson, a selective adenosine A1 agonist being investigated for the control of heart rate in atrial fibrillation. In the 63-patient, double-blind, placebo-controlled trial, all six administered doses of selodenoson demonstrated a statistically and clinically significant decrease in ventricular rate compared to placebo. These data were presented in a session exclusively focused on the management of atrial fibrillation during the American Heart Association's Scientific Sessions in Orlando, Florida.
"Currently, 6 million people worldwide suffer from atrial fibrillation, an abnormal heart rhythm caused by aberrant conduction of electrical impulses in the heart. The extremely rapid and irregular heartbeat associated with this condition can lead to deterioration of heart function. Current therapies are often limited by side effects," said Dr. McLaurin. "In this study, we demonstrated in patients with atrial fibrillation that selodenoson effectively reduced heart rate with no serious adverse events or changes in blood pressure."
The selodenoson Phase II data were discussed in an oral presentation entitled "Intravenous Selodenoson (Formerly DTI-0009), A Novel Adenosine A1 Agonist, Acutely Controls Ventricular Rate in Atrial Fibrillation Without Significant Hemodynamic Consequences." In the trial, patients were randomized to receive placebo or selodenoson at 2, 4, 6, 8, 10 or 12 mcg/kg doses as a 15-minute infusion. The heart rate was reduced by all doses at 5, 15 (end of infusion) and 30 minutes after beginning the infusion. There were no significant changes in systolic or diastolic blood pressure and no serious adverse events.
William Wheeler, M.D., FACC, Vice President and Chief Medical Officer of Aderis Pharmaceuticals, comments, "We are very pleased that our data were accepted for presentation at this prestigious international scientific conference. The analyses of the AFFIRM and RACE trials, also presented at the session, continue to support the treatment guidelines issued by organizations such as the American Heart Association, that most patients with atrial fibrillation should be treated with rate control."
Selodenoson is a potent and highly selective adenosine A1 agonist, under development by Aderis Pharmaceuticals and Fujisawa Healthcare, Inc., to control heart rate in patients with atrial fibrillation while minimizing changes in blood pressure or decreases in heart function. Selodenoson is in clinical development as an i.v. dosage form for in-hospital use and as a sustained release oral dosage form for chronic disease management on an outpatient basis. Fujisawa Healthcare, Inc. is developing the i.v. dosage form for the U.S. and Canadian markets. Aderis retains all other rights to the product.
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 subtype specific agonists and antagonists for the treatment of Parkinson's disease, Restless Legs Syndrome, atrial fibrillation, diabetic foot 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 King Pharmaceuticals, in addition to the alliance with Fujisawa Healthcare, Inc. 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.