Molecular Insight Pharmaceuticals' Zemiva Phase 2 Data Published in Journal of the American College of Cardiology
July 14 2010 - 8:01AM
Marketwired
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.
Contact: Investors Chuck Abdalian Chief Financial
Officer (617) 871-6618 cabdalian@molecularinsight.com Media
Martin A. Reynolds Manager Corporate Communications (617) 871-6734
mreynolds@molecularinsight.com Susan Pietropaolo BCC Partners (201)
923-2049 spietropaolo@bccpartners.com
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