ZemivaTM Normals Database From Molecular Insight Pharmaceuticals, Inc. Enables Accurate Determination of Abnormal Heart Activity
- Analysis of Quantification Tool to Facilitate Rapid Assessment of Acute Coronary Syndrome (ACS) Presented at American Society of Nuclear Cardiology -
Cambridge, MA, September 7, 2007 – Molecular Insight Pharmaceuticals, Inc. (NASDAQ: MIPI) announced today results of a study designed to develop and validate its ZemivaTM Normals reference database using gender-based and cardiac ischemia risk stratification parameters. Results indicated that the database accurately differentiated normal from abnormal metabolic heart activity in patients dosed with Zemiva. The Zemiva Normals reference database is designed to enable interpreting physicians to rapidly and quantitatively assess a patient's cardiac image against normal images contained in the database. Zemiva (iodofiltic acid I 123 or BMIPP) is a molecular imaging pharmaceutical in development by Molecular Insight for the diagnosis of cardiac ischemia, due to insufficient blood supply to the heart muscle, in patients with suspected acute coronary syndrome (ACS) in the emergency department setting. The data were presented in a poster presentation on September 6, 2007 at the annual meeting of the American Society of Nuclear Cardiology (ASNC) in San Diego, CA.
"The unique ability of Zemiva to rapidly and non-invasively image metabolic activity in the heart up to 30 hours after a cardiac event, combined with the demonstrated ability of the Normals reference database to accurately identify abnormal myocardial patterns, represents an outstanding opportunity to meaningfully improve patient care," said Dr. Norman LaFrance, Senior Vice President, Clinical Development and Chief Medical Officer of Molecular Insight. "Normals databases are now a cornerstone of effective patient management in nuclear cardiology and we believe Molecular Insight is the first company to incorporate a normals database into its clinical development plan. We also intend to use the database in the commercialization of Zemiva."
"A quantitative toolbox such as the Zemiva Risk-adjusted Normals database is useful to differentiate normal from abnormal cardiac images, compared to current methods of image interpretation that rely upon more qualitative indicators and which may produce inconsistent results. The risk criteria developed and tested in this study provide an objective way to stage patients' risk of ACS and therefore a more accurate interpretation of cardiac images," said Dr. Ernest V. Garcia, Professor of Radiology, Emory University School of Medicine, and an author on the study.
The study established gender-matched normal parameters for Zemiva and established criteria for a normal group and three sets of criteria for cardiac abnormality by stratifying patients into low, intermediate or high risk of ACS. Zemiva uptake in seven regions of the heart was compared to the mean normal, by gender, for each of the regions. Data were then analyzed and compared to normal. When all studies were compared to normal using criteria that consider ischemic risk, sensitivity increased from 67 percent to 96 percent in males and from 75 percent to 94 percent in females. Normalcy increased in males from 71 percent to 91 percent and in females from 67 percent to 84 percent. The study thus demonstrated that both the ability to detect disease and the ability to identify normality were improved by the use of risk-adjusted, gender specific criteria for cardiac abnormality.
"Automated quantitative software such as the Zemiva Normals database provides objective, accurate and reproducible data for the presence or absence of regional metabolic defects in the heart that is independent of the expertise of the reader," said Dr. Vasken Dilsizian, Professor of Medicine and Radiology, Chief, Division of Nuclear Medicine and Director of Cardiovascular Nuclear Medicine and Cardiac Positron Emission Tomography (PET) at the University of Maryland Medical Center. "Moreover, as we saw with the advent of ECGs in the emergency department, automated computer interpretations can optimize clinical workflow and the management of patients who present to the emergency room with ACS."
The poster, entitled, "Development and Retrospective Validation of a Risk-Adjusted, Gender-Matched Normal Database for I-123 BMIPP SPECT," was presented at the conference on September 6th. Authors were: R.D. Folks, E.V. Garcia, and L. Verdes, Emory University School of Medicine; T. Armor, Certus International; N. Borys, Molecular Insight Pharmaceuticals; and J.E. Udelson, Tufts-New England Medical Center.
About Zemiva and ACS
Every year, approximately five to eight million patients enter emergency rooms in the United States with suspected acute coronary syndrome or ACS, an umbrella term that refers to both cardiac ischemia and myocardial infarction. These life-threatening disorders are a major cause of emergency medical care and hospitalization, consume vast amounts of healthcare dollars and overly burden limited resources. Almost three million of these patients are admitted to the hospital for diagnosis, but approximately 15 percent are ultimately determined to have ACS. In addition, approximately 40,000 to 50,000 patients annually are inadvertently discharged although they have ACS, which may put some inappropriately discharged patients and hospitals at risk. Zemiva may provide the opportunity to improve disease management by rapidly identifying patients with ACS; reducing the number of missed diagnoses among discharged patients who may experience a heart attack or death soon afterwards; and reducing hospitalization costs by quickly ruling out patients whose condition is not due to ischemia.
Zemiva is a fatty acid analog also known as 123I-BMIPP that detects cardiac ischemia by revealing abnormalities in the fatty acid metabolism of the heart. Under normal conditions, 70 to 80 percent 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 at least 30 hours after chest pain has subsided.
In June 2007, Molecular Insight initiated a 600 to 700 patient, planned pivotal 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. 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 over 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 and targeted radiotherapeutics and molecular imaging pharmaceuticals with initial applications in the areas of oncology and cardiology. Its lead targeted radiotherapeutic product candidates, Azedra and Onalta, are being developed for detection and treatment of cancer. The company's lead molecular imaging pharmaceutical product candidate, Zemiva, is being developed for the diagnosis of cardiac ischemia, or insufficient blood flow to the heart. 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.
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