Acusphere Announces Data Demonstrating Imagify(TM) Perfusion Stress Echo is Well-tolerated and as Effective as Nuclear Perfusion Imaging for Evaluating Chest Pain Patients at Risk for Heart Attack
Tuesday November 6, 9:45 am ET
Final Phase 3 Data Presented in Oral Session at American Heart Association Meeting
ORLANDO, Fla. & WATERTOWN, Mass.--(BUSINESS WIRE)--Acusphere, Inc. (NASDAQ: ACUS - News) announced that data from its Phase 3 RAMP-1 (real time assessment of myocardial perfusion) and RAMP-2 clinical trials of Imagify™ (Perflubutane Polymer Microspheres) for Injectable Suspension were presented today at the annual American Heart Association meeting in Orlando, Florida. The results from these international multi-center trials indicate that Imagify Perfusion Stress Echo is an effective and well-tolerated, minimally invasive approach to evaluating chest pain patients at risk for heart attack.
Imagify is the first echocardiography imaging agent designed and shown in clinical trials to assess blood flow in the heart (perfusion). Myocardial perfusion is a sensitive marker of coronary heart disease (CHD). Currently, perfusion information is not available using echocardiography (cardiac ultrasound), but must be obtained using a nuclear stress test. Imagify Perfusion Stress Echo would have many potential benefits over nuclear stress testing, including quicker results, lower cost and no exposure to radioactivity. More than 10 million stress imaging procedures are done each year in the U.S. to detect heart disease, the leading cause of death in the United States.
“These Phase 3 data add to the growing body of efficacy and safety data on Imagify, which has now been evaluated in more than 1,000 patients, and further indicates that Imagify is an excellent perfusion imaging agent -- superior to standard stress echocardiography since it enables perfusion to be assessed, and just as accurate as nuclear stress testing,” said Roxy Senior, M.D., Director of Echocardiology in the Department of Cardiology at Northwick Park Hospital and the Imperial College of Medicine, London UK, and the lead investigator in the RAMP -1 and -2 Phase 3 trials. “Furthermore, the benefits of this important new approach for patients and physicians are very clear: ultrasound equipment is widely available, faster to use and far less expensive compared to nuclear stress testing. In addition, since there is no radiation involved, it is safer for the patient and eliminates hazardous waste disposal for the facility.”
According to the Phase 3 data presented today at the American Heart Association’s Scientific Sessions, when compared to nuclear stress — the most frequently used imaging procedure for the assessment of coronary heart disease – Imagify Perfusion Stress Echo was shown to be:
Just as good at determining whether or not a patient has disease (accuracy)
Superior in ruling out disease in patients with a lower prevalence of disease (specificity)
Superior in detecting disease in patients with a higher prevalence of disease (sensitivity)
“We are very proud that the American Heart Association has selected Acusphere’s full RAMP-1 and RAMP-2 data sets for oral presentation to the physician community here at Scientific Sessions. We see this data showing that Imagify is equivalent to the current standard of care –- nuclear stress — having shown equivalent accuracy in both trials,” said Sherri C. Oberg, President and CEO of Acusphere. “Imagify is a novel cardiac perfusion imaging agent, which for the first time will enable myocardial blood flow assessment in stress echo procedures. We believe the compelling data from these two Phase 3 trials supports a strong NDA submission early in 2008 to address a very significant medical need.”
Michael Picard, M.D., Director, Clinical Echocardiography at Massachusetts General Hospital Heart Center and clinical monitor for the RAMP-2 trial, stated, “Imagify Perfusion Stress Echo represents an exciting and easy to use technique. While the currently available echo technology can detect wall motion abnormalities one of the hallmarks of coronary artery disease, the detection of a patient’s myocardial blood flow would add a critical piece of the diagnostic puzzle when evaluating patients with heart ultrasound for their risk for heart attack. The results of the RAMP trials reported today suggest that Imagify will enable assessment of wall motion and blood flow, which when combined, is a stronger predictor of coronary artery disease than either finding alone.”
About RAMP-1 and RAMP-2 Phase 3 Trial Design
RAMP-1 and RAMP-2 were international, multi-center Phase 3 clinical trials designed to demonstrate that Imagify Perfusion Stress Echo at stress and rest is non-inferior to nuclear stress/rest testing in patients being evaluated for inducible ischemia. Non-inferiority and superiority analysis, compared to nuclear, was measured in three primary endpoints: accuracy, sensitivity and specificity.
RAMP-1 and -2 consisted of 285 and 377 evaluable efficacy angina patients, respectively. Patients from 28 international sites underwent Imagify Perfusion Stress Echo imaging and nuclear (quantitative myocardial perfusion imaging) at rest and at dipyridamole stress. Images were interpreted for presence of wall motion and/or perfusion abnormalities by independent blinded readers (3 Imagify and 1-3 nuclear readers for each study). Disease was defined by quantitative coronary angiography if available, or 90 day outcome, or clinical history and nuclear assessment. These results were statistically significant (statistical significance is defined by p<0.05). P values below represent non-inferiority significance.
RAMP-1 and RAMP-2 Results
RAMP-1
Accuracy: 3 of 3 ultrasound blinded readers were non-inferior (p<0.004)
Sensitivity: 1 of 3 ultrasound blinded readers was non-inferior (p=0.002)
Specificity: 2 of 3 ultrasound blinded readers were superior (p<0.006)
RAMP-2
Accuracy: 3 of 3 ultrasound blinded readers were non-inferior (p< 0.001)
Sensitivity: 3 of 3 ultrasound blinded readers were superior (p<0.002)
Specificity: 1 of 3 ultrasound blinded readers was non-inferior (p=0.013)
In the RAMP-1 and -2 trials, Imagify was well-tolerated with the majority of adverse effects (AEs) reported being mild in intensity, transient, and resolved without residual effects. The most common AEs reported were headache, chest pain or discomfort, nausea and flushing and occurred following dipyridamole dosing (an alternative to exercise stress) and required no treatment. |
