Molecular Insight Announces Positive Results from a Prospective Analysis of Phase 2b Data for Zemiva in Emergency Department Setting
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov 10, 2008 - Molecular Insight Pharmaceuticals, Inc. (NASDAQ: MIPI) announced today results of a prospective analysis of its Phase 2b clinical trial data (BP-21) suggesting that the addition of quantitative SPECT imaging with Zemiva (Iodofiltic acid I 123) to clinical information obtained in the emergency department setting has significant clinical value in rapidly identifying chest pain patients at high risk for acute coronary syndrome (ACS). The Company reported this analysis in a poster at the 2008 Scientific Sessions of the American Heart Association (AHA). The design of this analysis parallels the Company's ongoing planned pivotal Phase 2 registration trial for Zemiva (BP-23). Top-line results from the BP-23 trial, which will include Zemiva's performance in the detection of cardiac ischemia as well as ACS, the most severe form of cardiac ischemia, are expected by year-end.
In this analysis, the combination of Zemiva imaging with initial clinical information resulted in improved sensitivity (84%) that was statistically significant (p=0.003), compared to the sensitivity of the initial clinical diagnosis alone (54%). The quantitative Zemiva imaging alone provided an increased sensitivity for the diagnosis of definitive or probable ACS over the initial clinical diagnosis alone (76% vs. 54%, p=0.06). There was a slight reduction in specificity for the diagnosis of definitive or probable ACS, but the reduction was not statistically significant. The negative predictive value increased to 89% for patients with definitive or probable ACS when Zemiva was added, up from 76% with standard diagnostic techniques alone.
"We compared the incremental value of adding quantitative Zemiva imaging to the initial diagnosis of the patient using established, qualitative techniques. The most important criteria for identifying patients who do and do not have acute coronary syndrome, sensitivity and negative predictive value, increased substantially with the addition of Zemiva, particularly for patients whose initial diagnosis was equivocal or negative for definitive or probable ACS," said Michael C. Kontos, M.D., Associate Professor, Cardiology, Virginia Commonwealth University, and an author on the study.
Dr. Kontos continued, "In the emergency department setting, the most urgent priority for physicians in assessing chest pain patients is to identify those with ACS, who require immediate care, and rule out those whose symptoms result from other causes. However, definitive diagnosis of chest pain is frequently problematic, with many patients undergoing costly hospital stays and prolonged observation."
Of the millions of patients who travel to emergency departments each year due to chest pain, many are symptom free at, or shortly after, arrival. A number of industry studies have demonstrated that myocardial perfusion imaging (MPI) provides additional diagnostic value to established procedures, such as serial electrocardiogram (ECG) and cardiac biomarkers, in diagnosing chest pain in the emergency department. However, perfusion imaging is limited in its ability to detect ischemia after chest pain has resolved. Previous Molecular Insight studies have demonstrated that Zemiva, which images ischemia-induced defects in cardiac cell metabolism, has the potential to identify cardiac ischemia rapidly, at rest, in patients who have experienced chest pain within the previous 30 hours.
"We are very encouraged by this analysis, which is designed to reflect information that would be available to clinicians in a real world environment and further demonstrates Zemiva's ability to quickly and accurately inform the diagnosis of heart conditions in the emergency department setting," said John W. Babich, Ph.D., Interim Chairman and Chief Executive Officer of Molecular Insight, and an author on the study. "We are using a similar analysis in our planned pivotal Phase 2 registration trial currently underway for Zemiva for the diagnosis of cardiac ischemia in the emergency department setting. Enrollment in that study was completed over the summer and we remain on track to report top-line results by year-end."
Dr. Babich noted that the Phase 2b analysis presented at the AHA builds on a prospective analysis of images from the Phase 2b study using the Company's established Normals Reference Database. That analysis was presented in September 2007 at the annual meeting of the American Society of Nuclear Cardiology (ASNC).
The analysis was based on an open label study of 105 patients at eight centers that enrolled emergency department patients with chest pain consistent with ACS. Patients received Zemiva injections within 30 hours of cessation of chest pain. The Zemiva images were imaged and read using quantitative software along with the Company's established Normals Reference Database. Clinical evaluation, along with ECGs and troponin level assessments, were conducted on all patients with stress MPI and/or angiography when clinically indicated. The final diagnosis of definitive ACS or definitive/probable ACS for each subject was determined by an algorithm that used all clinically available information for each subject, including results for angiography, MPI/SPECT, troponin, ECG and symptoms collected from the time of admission up to 30 days of follow-up.
Definitive ACS was defined in the study as elevated troponin or revascularization. Definitive/probable ACS was defined as either the presence of ACS or significant coronary stenosis determined by angiography or ischemia based on stress SPECT test. -0-
Definite ACS Definite or probable ACS (Positive=24, Negative=79) (Positive=37, Negative=66) ---------------------------- ---------------------------- Test Sensitivity Specificity NPV Sensitivity Specificity NPV (%) (%) (%) (%) (%) (%) ----------- ----------- ---- ----------- ----------- ---- InDx 83 80 94 54 82 76 BMIPP 88 77 95 76 71 84 InDx+ BMIPP 100 77 100 84 71 89
The study, presented as a poster, is entitled: "Iodofiltic Acid I 123 SPECT Provides Incremental Diagnostic Value over Initial Clinical Information in Emergency Department Patients with Suspected Acute Coronary Syndrome." In addition to Drs. Babich and Kontos, the authors on the study included: Jonathan L. Goldman, ICON Medical Imaging, Warrington, PA; Yong Li, Katherine Kacena and Norman LaFrance, Molecular Insight Pharmaceuticals, Inc., Cambridge, MA; and James E. Udelson, Tufts Medical Center, Boston, MA. The final poster can be found on the Molecular Insight website at: www.molecularinsight.com
Zemiva is a fatty acid analog also known as 123I-BMIPP or Iodofiltic Acid I 123 that detects cardiac ischemia by revealing abnormalities in the fatty acid metabolism of the heart. Under normal conditions, 70% to 80% of the energy for the heart is produced by the metabolism of fatty acids. However, in ischemic conditions where there is a lack of oxygen, fatty acid metabolism is drastically reduced and carbohydrates become the heart's primary energy source. This shift in metabolic activity persists for some time, and the phenomenon, called ischemic memory, has been shown by Zemiva imaging to persist for at least 30 hours after chest pain has subsided.
In June 2007, Molecular Insight initiated a planned pivotal Phase 2 registration trial to assess the ability of Zemiva to detect cardiac ischemia in the emergency room setting. The trial is the first of two planned pivotal registration trials for Zemiva for this indication and the Company expects to report top-line data from the trial in 2008. The study follows four U.S. clinical trials with Zemiva, a Phase 1 study and three Phase 2 trials, including a Phase 2 clinical trial to develop a reference database of normal Zemiva images of the heart using SPECT imaging. The BMIPP molecule is approved and commercialized in Japan and has been used in more 500,000 patients.
About Molecular Insight Pharmaceuticals, Inc.
Molecular Insight Pharmaceuticals (NASDAQ: MIPI) is a biopharmaceutical company specializing in the emerging field of molecular medicine, applying innovations in the identification and targeting of disease at the molecular level to improve healthcare for patients with life-threatening diseases. The Company is focused on discovering, developing and commercializing innovative molecular imaging radiopharmaceuticals and targeted molecular radiotherapeutics with initial applications in the areas of cardiology and oncology. Molecular Insight's lead molecular imaging radiopharmaceutical product candidate, Zemiva, is being developed for the diagnosis of cardiac ischemia, or insufficient blood flow to the heart. The Company's imaging candidate, Trofex(TM), is in development for the detection of metastatic prostate cancer. Molecular Insight's lead molecular radiotherapeutic product candidates, Azedra(TM) and Onalta(TM), are being developed for detection and treatment of cancer. In addition, the Company has a growing pipeline of product candidates resulting from application of its proprietary platform technologies to new and existing compounds. Molecular Insight Pharmaceuticals is based in Cambridge, Massachusetts and its website address is: www.molecularinsight.com.
Statements in this release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, statements about the development of Azedra(TM), Onalta(TM), Zemiva(TM), Trofex(TM) and our other product candidates. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause the actual results of Molecular Insight to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to the progress, timing, cost and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval for product candidates; competition from other pharmaceutical or biotechnology companies; and the additional risks discussed in filings with the Securities and Exchange Commission (SEC). The Company's SEC filings are available through the SEC's Electronic Data Gathering Analysis and Retrieval system (EDGAR) at www.sec.gov. Press releases for Molecular Insight Pharmaceuticals, Inc. are available on our website: www.molecularinsight.com. If you would like to receive press releases via email, please contact: firstname.lastname@example.org. All forward-looking statements are qualified in their entirety by this cautionary statement, and Molecular Insight undertakes no obligation to revise or update this release to reflect events or circumstances after the date hereof.
Molecular Insight Pharmaceuticals, Inc.
Deborah S. Lorenz, 617-871-6667
Investor Relations and Corporate Communications
Posted: November 2008