Acusphere Announces Data Demonstrating Imagify Perfusion Stress Echo is Well-tolerated and as Effective as Nuclear Perfusion Imaging for 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 less than 0.05). P values below represent non-inferiority significance.
RAMP-1 and RAMP-2 Results
-- Accuracy: 3 of 3 ultrasound blinded readers were non-inferior (p less than 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 less than 0.006)
-- Accuracy: 3 of 3 ultrasound blinded readers were non-inferior (p less than 0.001)
-- Sensitivity: 3 of 3 ultrasound blinded readers were superior (p less than 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.
Imagify(TM) is an investigational new drug developed to assess perfusion using ultrasound (or echocardiography) for the detection of coronary heart disease. Myocardial perfusion is blood flow in the heart muscle and is a sensitive marker of coronary heart disease. Currently, perfusion information is not available using cardiac ultrasound but must be obtained using a nuclear stress test, which is the most frequently used imaging procedure for detecting coronary heart disease. Imagify is designed to provide real-time perfusion information with quicker results, lower cost, broader access and no exposure to radiation compared with nuclear stress tests. Imagify was designed to be used with commercially available ultrasound equipment and established imaging techniques.
According to the American Heart Association, approximately 16 million people in the United States suffer from coronary heart disease (CHD), the single leading cause of death in the United States. CHD is characterized by the accumulation of plaque, which narrows coronary arteries and reduces blood flow in the heart muscle. The reduced blood flow can cause chest pain, and if the plaque ruptures, it may cause a heart attack. The American Heart Association estimates that the direct and indirect cost of CHD in the United States for 2007 is more than $150 billion.
Early detection of CHD can save lives, reduce treatment costs and improve patients' quality of life. Two of the most common methods of CHD screening are nuclear stress imaging and stress echocardiography, or "stress echo"--ultrasound of the heart. In 2006, more than 10 million of these screening procedures were performed in the United States, including more than seven million nuclear stress tests and nearly three million stress echo procedures.
About Acusphere, Inc.
Acusphere is a specialty pharmaceutical company that develops new drugs and improved formulations of existing drugs using its proprietary microsphere technology. We are focused on developing proprietary drugs that can offer significant benefits such as improved safety and efficacy, increased patient compliance, greater ease of use, expanded indications or reduced cost. Our lead product candidate, Imagify(TM) (Perflubutane Polymer Microspheres) for Injectable Suspension, is a cardiovascular drug for the detection of coronary heart disease, the leading cause of death in the United States. In May 2007 we announced the results of our Phase 3 pivotal trials for Imagify. We are currently working towards submitting an NDA (New Drug Application) for Imagify. Imagify is designed to enable ultrasound to compete more effectively with nuclear stress testing, the leading procedure for detecting coronary heart disease. It is estimated that over 10 million procedures are done each year in the U.S. to detect coronary heart disease, the leading cause of death in the United States. Imagify and the Company's other product candidates were created using proprietary technology that enables Acusphere to control the porosity and size of nanoparticles and microspheres in a versatile manner that allows them to be customized to address the delivery needs of a variety of drugs. For more information about Acusphere visit the Company's web site at www.acusphere.com.
"Acusphere" and "Imagify" are trademarks of Acusphere, Inc.
Glossary of Terms Used Above
Accuracy: a measure of all patients that are correctly evaluated out of all the patients in the study.
Blinded Readers: physicians with expertise in reading cardiac ultrasound images (ultrasound blinded reader) or nuclear stress images (nuclear blinded reader). The physicians have access to no clinical information about the patient, and so blinded reading is much more difficult than reading in the normal clinical setting, where physicians have access to patient history, symptoms and other test results.
Non-inferiority: a statistical type of trial analysis, which is designed to show that one test is comparable to another test, within a certain statistical margin of error.
Myocardial Perfusion: blood flow to the heart muscle.
NDA: New Drug Application seeking U.S. regulatory approval to market and sell a new drug such as Imagify.
P value: a statistical measure of the probability that the particular result obtained in a trial could have happened by random chance.
Sensitivity: The ability to detect disease when present.
Specificity: The ability to detect the absence of disease when not present.
The above press release contains forward-looking statements, which are made pursuant to the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934, including statements regarding the commercial opportunity for Imagify and other product development and the likelihood of any partnership discussions resulting in an agreement. The Company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including anticipated operating losses and existing capital obligations, uncertainties associated with research, development, testing and related regulatory approvals, including uncertainties regarding regulatory evaluation of the Company's statistical analysis plan and clinical trial results and uncertainties regarding the potential effects of not achieving clinical endpoints, limited time to date for the Company to review the details of the clinical trial results, future capital needs and uncertainty of additional financing, uncertainties regarding the cost, timing and ultimate success of the qualification of the Company's commercial manufacturing facility in accordance with applicable regulatory requirements, complex manufacturing, high quality requirements, lack of commercial manufacturing experience, dependence on third-party manufacturers, suppliers and collaborators, uncertainties associated with intellectual property, competition, loss of key personnel, uncertainties associated with market acceptance and adequacy of reimbursement, technological change and government regulation, and other risks and challenges detailed in the Company's filings with the U.S. Securities and Exchange Commission, including the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2007. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this press release or to reflect the occurrence of unanticipated events.
Mary T. Conway, 617-244-9682
Pure Communications Inc.
Susan Heins, 864-346-8336
Posted: November 2007