Acusphere Successfully Trains Echo Blinded Readers to Increase Sensitivity While Maintaining Accuracy.-Process Expected to Improve Likelihood of RAMP-2 Success- WATERTOWN, Mass. -- Acusphere, Inc. (Nasdaq: ACUS acus (a´kus) a needle or needle-like process. acus a needle or needle-like process. ) announced today that the Company has trained all of the echo blinded readers in the RAMP-2 trial to increase their sensitivity, the ability to detect coronary heart disease coronary heart disease: see coronary artery disease. coronary heart disease or ischemic heart disease Progressive reduction of blood supply to the heart muscle due to narrowing or blocking of a coronary artery (see atherosclerosis). , in stress echo images Echo Image is a Norwegian synthpop band. The band unofficially started in 1997 when Pål Magnus Rybom started experimenting with electronic music. Later that year Fredrik Hansen joined and Echo Image was officially formed with Trine Bilet joining towards the end of the year enhanced by its lead product candidate, Imagify[TM] (formerly known as AI-700). In connection with this training, all RAMP-2 echo blinded readers read with higher sensitivity than prior to the training, while maintaining high accuracy, the ability to correctly determine the presence or absence of disease. All of these echo blinded readers read at accuracy, sensitivity and specificity levels that were similar to that of the nuclear reader in RAMP-1. "We are encouraged by the results of the blinded reader training. In RAMP-1, we demonstrated that Imagify's accuracy is non-inferior and its specificity is superior to nuclear stress. We believe that reading all of the RAMP-2 images with the newly trained echo blinded readers should position RAMP-2 very well to demonstrate that Imagify's sensitivity is also non-inferior to nuclear stress," stated Dr. Richard Walovitch, Senior Vice President of Clinical Research for Acusphere. Acusphere plans to take advantage of the improvements from training by having the newly trained RAMP-2 echo blinded readers completely read all 457 Imagify images. As a result, Acusphere anticipates that additional time may be required to complete this expanded process. The Company currently expects that the results from RAMP-2 will be publicly available in the second quarter of 2007, and that the NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any submission for Imagify will occur in the second half of 2007. No additional patients are expected to be enrolled in the RAMP-2 study. The training was conducted using more than 100 cases from the recently completed and un-blinded RAMP-1 trial for Imagify. The Company intends to continue training the echo blinded readers in an effort to ensure that the gains in sensitivity do not lower specificity below targeted levels. The Company's two pivotal trials, RAMP-1 and RAMP-2, are designed to demonstrate the non-inferiority of Imagify-enhanced stress echo to nuclear stress, which is the leading method to screen for coronary heart disease. The second pivotal trial, RAMP-2, has completed enrollment but remains blinded. The primary endpoints for RAMP-1 and RAMP-2 are accuracy, followed by sensitivity and specificity. "Training our RAMP-2 echo blinded readers to read images with increased sensitivity while maintaining accuracy is exactly what we set out to demonstrate and provides us with a considerable opportunity to optimize our chances for positive outcome," stated Sherri C. Oberg, Acusphere's President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "In RAMP-1, we met the accuracy endpoint, which we believe is the most important endpoint for submitting the NDA. However, we missed the sensitivity endpoint. At the time, we stated our hypothesis that echo blinded readers who are accurate can be trained to read with higher sensitivity. We believe that the results of the training validate this hypothesis." About Imagify[TM] (perflubutane polymer microspheres) injectable in·ject·a·ble adj. Capable of being injected. Used of a drug. n. A drug or medicine that can be injected. suspension Imagify[TM] (pronounced i-maj'-i-fE'), formerly known as AI-700, is an investigational ultrasound contrast agent in Phase 3 clinical development, designed to provide physicians with valuable information on myocardial myocardial /myo·car·di·al/ (-kahr´de-al) pertaining to the muscular tissue of the heart. myocardial pertaining to the muscular tissue of the heart (the myocardium). perfusion perfusion /per·fu·sion/ (-zhun) 1. the act of pouring over or through, especially the passage of a fluid through the vessels of a specific organ. 2. a liquid poured over or through an organ or tissue. . The Company is developing Imagify to enable stress echo to assess myocardial perfusion and believes that ultrasound with Imagify has the potential to be a cost effective and convenient method to screen for coronary heart disease. Imagify was designed to be used with commercially available ultrasound equipment and established imaging techniques and has been studied in more than 1000 patients to date. Glossary of Terms Used Above Accuracy: a measure of all patients that are correctly diagnosed out of all the patients in the study. Blinded Readers: physicians with expertise in reading stress echo images (echo 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. RAMP-1 and RAMP-2: The two pivotal Phase 3 trials conducted by Acusphere to assess the safety and efficacy of Imagify. The purpose of these trials is to demonstrate that stress echo with Imagify[TM] is non-inferior to nuclear stress testing Determining the durability of a system by pushing it to its limits. Stress testing a network is performed by transmitting excessive numbers of packets or attempting to break in illegally. . RAMP is an abbreviation abbreviation, in writing, arbitrary shortening of a word, usually by cutting off letters from the end, as in U.S. and Gen. (General). Contraction serves the same purpose but is understood strictly to be the shortening of a word by cutting out letters in the middle, of Real-time Assessment of Myocardial Perfusion with echocardiography Echocardiography Definition Echocardiography is a diagnostic test that uses ultrasound waves to create an image of the heart muscle. Ultrasound waves that rebound or echo off the heart can show the size, shape, and movement of the heart's valves and . Sensitivity: The ability to detect disease when present. Specificity: The ability to detect the absence of disease when not present. About Acusphere, Inc. Acusphere (NASDAQ: ACUS) is a specialty pharmaceutical company that develops new drugs and improved formulations of existing drugs using its proprietary microsphere Not to be confused with Glass microphere. This article largely refers to micropheres or protein protocells as small spherical units postulated by some scientists as a key stage in the origin of life. technology. Acusphere's three initial product candidates are designed to address large unmet clinical needs within cardiology cardiology Medical specialty dealing with heart diseases and disorders. It began with the 1749 publication by Jean Baptiste de Sénac of contemporary knowledge of the heart. Diagnostic methods improved in the 19th century, and in 1905 the electrocardiograph was invented. , oncology and asthma. These 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. Acusphere's lead product candidate, Imagify[TM] (formerly known as AI-700), is a cardiovascular drug in Phase 3 clinical development. Imagify is designed to enable ultrasound to compete more effectively with nuclear stress testing, the leading procedure for detecting coronary heart disease. An estimated 11.9 million procedures are done each year in the U.S. to detect coronary heart disease, the leading cause of death in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . For more information about Acusphere visit the Company's web site at www.acusphere.com. "Acusphere" is a trademark of Acusphere, Inc. Forward-looking Statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. The above press release contains forward-looking statements which are made pursuant to the safe harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. provisions of Section 21E of the Securities Exchange Act of 1934. Investors are cautioned that statements in this press release, including statements relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the ability of echo blinded readers to read at higher levels of sensitivity while maintaining accuracy and acceptable specificity, and statements relating to the timing and success of RAMP-2 results and the timing of an NDA for Imagify, constitute forward-looking statements which involve risks and uncertainties. The Company's actual results may differ materially from those anticipated in these forward-looking statements. There can be no assurance that the results of the RAMP-2 trial will be successful, even after the training efforts described in this release. 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 operating loss The excess of operating expenses over revenue. As with operating income, operating losses exclude revenues and expenses from operations that are not considered a regular part of the business. Also called deficit. Compare operating income. and existing capital obligations, uncertainties associated with research, development, testing and related regulatory approvals, including uncertainties regarding the ultimate outcome of Acusphere's Phase 3 clinical trials phase 3 clinical trial Phase 3 study. See Phase study. for Imagify[TM] and uncertainties regarding the number of patients required to complete the Phase 3 clinical trials, 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, competition, uncertainties associated with intellectual property, loss of key personnel, 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 Form 10-Q See 10-Q. for the quarter ended June 30, 2006. 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. |
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