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Phase III Clinical Trial Involving Binodenoson To Begin

BRISTOL, Tenn., Dec. 5 /PRNewswire-FirstCall/ -- King Pharmaceuticals, Inc. announced today the commencement of the Phase III clinical trial program involving binodenoson. Binodenoson is an adenosine A2A receptor agonist that King is developing for cardiac pharmacologic stress SPECT imaging, a procedure used to diagnose the presence and severity of coronary artery disease. The initial dosing of patients participating in the trial is scheduled to begin later today.

Michael K. Jolly, Pharm. D., Executive Vice President, Research and Development, of King, stated, "We are very pleased to report that we are commencing our international, multi-center, double blind, controlled Phase III clinical trial program involving King's binodenoson product. This program is designed to provide pivotal clinical evidence of the safety and efficacy of binodenoson, and to confirm the positive results that were evident in the Phase II clinical trials involving the drug. We presented the data from our successful Phase I and Phase II clinical trials involving binodenoson at meetings of the American Heart Association and American Society of Nuclear Cardiology earlier this year."

Dr. Jolly observed, "Approximately 3 million pharmacologic stress tests are performed in the United States each year to diagnose heart disease in patients who cannot perform traditional exercise stress tests. Adenosine and dipyridamole are the current agents of choice to achieve the coronary vasodilation necessary for cardiac imaging in the United States, but these drugs do not distinguish between the four subtypes of adenosine receptors. Our Phase II clinical trials showed that by targeting the adenosine A2A receptor subtype, binodenoson appears to detect myocardial ischemia as well as adenosine, and produces fewer and less severe side effects like heart block, dyspnea and chest pain than adenosine and dipyridamole. Unlike the currently used drugs, which are administered over 4 to 6 minutes, binodenoson will be given as an IV bolus dose. This advantage, coupled with the improved safety profile, promises to make these diagnostic tests safer for patients and easier and more efficient for physicians to administer."

Phase II clinical trials involving binodenoson included MRE0470P-206, a Phase II, multi-center, randomized, single-blind, two-arm crossover dose- selection study that enrolled 240 patients with high pretest likelihood for coronary artery disease ("CAD") or known and symptomatic CAD. All patients underwent, in random sequence, a standard pharmacologic stress test with adenosine, and a second, single-blind, pharmacologic stress test with one of four randomly selected doses of binodenoson. Safety, tolerability, and pharmacologic stress SPECT image concordance comparisons between binodenoson and adenosine were examined. There was good to excellent image concordance with all four binodenoson doses and adenosine. Patients reported fewer and less severe side effects, including chest pain, shortness of breath, and flushing during the binodenoson procedure than they did during the adenosine procedure. None of the patients experienced A-V block with binodenoson, compared to an incidence of 3% with adenosine. The incidence and the intensity of side effect reductions using binodenoson were dose-related.

Source: King Pharmaceuticals, Inc.

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