Molecular Insight Pharmaceuticals' Zemiva Phase 2 Data Published in Journal of the American College of Cardiology
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Molecular Insight Pharmaceuticals, Inc. has announced that detailed results from a completed Phase 2 clinical trial of Zemiva™ 1 (Iodofiltic acid I 123) will be published in the July 20, 2010 edition of the Journal of the American College of Cardiology, which is now available online.
Zemiva is a molecular imaging radiopharmaceutical designed for the rapid detection of myocardial ischemia and acute coronary syndrome (ACS) which result from insufficient blood flow to the heart muscle. Zemiva detects abnormalities in fatty acid metabolism associated with ischemia, which can lead to heart attack.
In "Iodofiltic Acid I 123 (BMIPP) Fatty Acid Imaging Improves Initial Diagnosis in Emergency Department Patients with Suspected Acute Coronary Syndromes: A Multicenter Trial," researchers confirmed that the addition of Zemiva imaging data to initially available clinical information contributes to the early diagnosis and evaluation of ACS.
Emergency department (ED) diagnosis of chest pain is problematic, often requiring prolonged observation and testing to obtain confirmatory data. Patients presenting with chest pain and other symptoms consistent with ACS account for eight percent to 10 percent of the approximately 10 million ED patient visits each year. Accurately identifying the potential high-risk patients among the large number of low-risk patients is particularly challenging, as most patients require extensive evaluation requiring hospital admission or prolonged observation.
"Our research suggests that Zemiva has promise to be an important tool in the diagnosis of acute coronary syndrome, offering improved sensitivity that may allow physicians to determine the presence or absence of ACS earlier in the diagnostic workup," said James E. Udelson, M.D., Chief, Division of Cardiology and Director of Nuclear Cardiology at Tufts Medical Center, who was principal study investigator.
During the open-label trial (BP-23), the safety and efficacy of Zemiva were evaluated in 507 patients with symptoms suggestive of ACS at emergency departments at 50 hospitals in North America. The addition of results from Zemiva imaging demonstrated an improvement in sensitivity (from 43 to 81%, p < 0.001), positive predictive value (from 41 to 58%, p < 0.001) and negative predictive value (from 62 to 83%, p < 0.001) over the initial clinical information alone for ACS within 30 hours of cessation of chest pain symptoms, while maintaining specificity. The ability to image ischemic abnormalities even after symptoms resolve is a unique feature of the agent.
One hundred and nine of these patients (21.5%) reported adverse events. Most adverse events reported in the trial were judged mild in severity by the investigators; the most common event was headache (3.9%). There were serious adverse events (SAEs) reported in 27 patients (5.3%) including 4 deaths during the 30-day follow-up period. None of these SAEs was considered by the investigators to be drug related. Post-administration clinical laboratory values and vital signs showed only clinically insignificant changes from baseline.
Zemiva is a molecular imaging radiopharmaceutical designed for the rapid detection of myocardial ischemia and acute coronary syndrome (ACS) which result from insufficient blood flow to the heart muscle. Zemiva detects abnormalities in fatty acid metabolism associated with ischemia, which can lead to heart attack.
In "Iodofiltic Acid I 123 (BMIPP) Fatty Acid Imaging Improves Initial Diagnosis in Emergency Department Patients with Suspected Acute Coronary Syndromes: A Multicenter Trial," researchers confirmed that the addition of Zemiva imaging data to initially available clinical information contributes to the early diagnosis and evaluation of ACS.
Emergency department (ED) diagnosis of chest pain is problematic, often requiring prolonged observation and testing to obtain confirmatory data. Patients presenting with chest pain and other symptoms consistent with ACS account for eight percent to 10 percent of the approximately 10 million ED patient visits each year. Accurately identifying the potential high-risk patients among the large number of low-risk patients is particularly challenging, as most patients require extensive evaluation requiring hospital admission or prolonged observation.
"Our research suggests that Zemiva has promise to be an important tool in the diagnosis of acute coronary syndrome, offering improved sensitivity that may allow physicians to determine the presence or absence of ACS earlier in the diagnostic workup," said James E. Udelson, M.D., Chief, Division of Cardiology and Director of Nuclear Cardiology at Tufts Medical Center, who was principal study investigator.
During the open-label trial (BP-23), the safety and efficacy of Zemiva were evaluated in 507 patients with symptoms suggestive of ACS at emergency departments at 50 hospitals in North America. The addition of results from Zemiva imaging demonstrated an improvement in sensitivity (from 43 to 81%, p < 0.001), positive predictive value (from 41 to 58%, p < 0.001) and negative predictive value (from 62 to 83%, p < 0.001) over the initial clinical information alone for ACS within 30 hours of cessation of chest pain symptoms, while maintaining specificity. The ability to image ischemic abnormalities even after symptoms resolve is a unique feature of the agent.
One hundred and nine of these patients (21.5%) reported adverse events. Most adverse events reported in the trial were judged mild in severity by the investigators; the most common event was headache (3.9%). There were serious adverse events (SAEs) reported in 27 patients (5.3%) including 4 deaths during the 30-day follow-up period. None of these SAEs was considered by the investigators to be drug related. Post-administration clinical laboratory values and vital signs showed only clinically insignificant changes from baseline.
