SOURCE: Molecular Insight Pharmaceuticals, Inc.

Molecular Insight Pharmaceuticals, Inc.

July 14, 2010 08:01 ET

Molecular Insight Pharmaceuticals' Zemiva Phase 2 Data Published in Journal of the American College of Cardiology

CAMBRIDGE, MA--(Marketwire - July 14, 2010) -  Molecular Insight Pharmaceuticals, Inc. (NASDAQ: MIPI) today 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.

The Company continues to explore opportunities to out license Zemiva, in conjunction with its strategic focus on oncology.

About Zemiva and High Quality Imaging of Ischemic Events
Zemiva (Iodofiltic acid I 123) is an iodine-123 labeled fatty acid analog delivered by intravenous injection.  Zemiva is retained in heart cells that have a healthy blood supply but not retained in areas of the heart that have suffered an ischemic event.  Because of its high uptake and prolonged retention in healthy heart cells, Zemiva provides high quality images of the heart.  Previous studies have indicated that sustained decrease in fatty acid metabolism may allow Zemiva to visualize an ischemic event for up to 30 hours after it has occurred.  Ischemic memory is a unique capability of Zemiva, which may make it valuable for imaging in the acute setting, when stress testing cannot be tolerated, and in patients whose symptoms have since subsided.  Zemiva can be imaged using standard nuclear medicine cameras which are found in all accredited hospitals throughout the United States. 

About Molecular Insight Pharmaceuticals, Inc.
Molecular Insight Pharmaceuticals is a clinical-stage biopharmaceutical company and pioneer in the emerging field of molecular medicine. The Company is focused on the discovery and development of targeted therapeutic and imaging radiopharmaceuticals for use in oncology. Molecular Insight has five clinical-stage candidates in development. For further information on Molecular Insight Pharmaceuticals, please visit www.molecularinsight.com.

Forward-Looking Statements
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 promising role of Zemiva in the diagnosis of acute coronary syndrome and unique ability to image ischemic abnormalities even after symptoms resolve, as well as the potential out-licensing of Zemiva. 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 e-mail, please contact: investor@molecularinsight.com. 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.

(1) Detailed results announced in Company press release: March 26, 2009.

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