Molecular Insight Pharmaceuticals, Inc. Initiates Trofex(TM) Phase 1 Trial for the Detection and Staging of Metastatic Prostate
June 12 2008 - 8:30AM
Business Wire
Molecular Insight Pharmaceuticals, Inc. (NASDAQ: MIPI) announced
today that it has initiated a Phase 1 clinical trial for its Trofex
molecular imaging program for the detection and staging of
metastatic prostate cancer. The trial is designed to investigate
two small molecule radiopharmaceutical candidates that target
prostate-specific membrane antigen (PSMA), MIP-1072 and MIP-1095,
in order to select a lead candidate for further development and
commercialization. Molecular Insight is conducting the study under
an exploratory Investigational New Drug (IND) application submitted
to the U.S. Food and Drug Administration (FDA). �Trofex expands our
oncology portfolio into the arena of molecular imaging
radiopharmaceuticals for the detection, monitoring and staging of
disease such as prostate cancer, providing an important strategic
complement to our portfolio of molecular radiotherapeutics for
cancer,� said David S. Barlow, Chairman and CEO of Molecular
Insight. �Trofex is now our fourth clinical-stage program, joining
Zemiva, Azedra and Onalta. Both candidate compounds in this Trofex
clinical study were discovered in-house by applying our expertise
in molecular targeting, drug design and radiochemistry towards the
detection and monitoring of prostate cancer.� MIP-1072 and MIP-1095
are radiolabeled small molecules developed by Molecular Insight
that target PSMA, a protein that is highly expressed by prostate
cancer cells. PSMA is well established as a molecular target for
prostate cancer and coupling it with an imaging radionuclide
enables a rapid, non-invasive way to detect the location of
metastatic cancer. �Prostate cancer is the second leading cause of
cancer death in men in the United States, and new methods to
detect, stage and monitor disease progression are urgently needed
for more effective patient management of this disease,� said Dr. R.
Edward Coleman, M.D., Vice-Chair, Department of Radiology,
Professor of Radiology and Director of Nuclear Medicine at Duke
University Medical Center. �A targeted radiopharmaceutical capable
of rapidly and accurately detecting the location of metastatic
prostate cancer throughout the body, including the bone, would be a
significant advance in patient care.� �In preclinical studies, both
MIP-1072 and MIP-1095 have demonstrated promising attributes, such
as high affinity for PSMA, significant uptake into tumor cells and
favorable clearance from normal tissues,� said John W. Babich,
Ph.D., President and CSO of Molecular Insight. �The exploratory IND
process accelerated our entry into the clinic to evaluate which
compound is the more promising for further development. We plan to
complete this study in the second half of 2008 and then, once
initial safety and imaging efficacy criteria are met, advance the
selected lead candidate into expanded Phase 2 clinical
development.� Dr. Babich noted that preclinical data in support of
MIP-1072 and MIP-1095 were presented in October 2007 at the
AACR-NCI-EORTC meeting on "Molecular Targets and Cancer
Therapeutics.� The trial, which will involve up to 12 patients, is
a single-blind, randomized cross-over study. Patients will receive
a single dose of MIP-1072 or MIP-1095, followed by a single dose of
the alternate candidate compound 14 days later. The study is being
conducted at Duke University Medical Center, New York Presbyterian
Hospital-Cornell Medical Center and Johns Hopkins Hospital. The
primary objective of the trial is to evaluate the pharmacokinetics
and organ radiation dosimetry of the two compounds in patients
diagnosed with prostate cancer who have evidence of recurrent
metastatic disease. Secondary objectives include assessments of
excretion, metabolism, safety and optimization of tumor imaging
parameters. About Prostate Cancer Prostate cancer is the most
frequently diagnosed cancer in men in the United States, with
218,000 new cases per year. It is the second leading cause of
cancer deaths in men, and one in six men will be diagnosed with
prostate cancer during his lifetime. There is an important unmet
need for accurate, rapid and non-invasive tools to determine
whether the cancer has spread to other parts of the body and to
help guide treatment. Current techniques have significant
limitations and often do not confirm the presence of cancer,
allowing tumors to remain undetected. About Molecular Insight
Pharmaceuticals, Inc. Molecular Insight Pharmaceuticals (NASDAQ:
MIPI) is the leading 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, targeted radiotherapeutics and molecular imaging
radiopharmaceuticals with initial applications in the areas of
oncology and cardiology. Molecular Insight�s lead targeted
radiotherapeutic product candidates, Azedra and Onalta, are being
developed for detection and treatment of cancer. The company�s lead
molecular imaging radiopharmaceutical 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.
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 Azedra�, Onalta�, Zemiva�, Trofex� and any other
statements relating to product candidates or the applicable
regulatory process, including clinical development programs and
projected clinical milestones. Such statements may include, without
limitation, statements with respect to the company's plans,
objectives, expectations and intentions and other statements
identified by words such as "may," "could," "would," "should,"
"believes," "expects," "anticipates," "estimates," "intends,"
"plans" or similar expressions. 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. All forward-looking statements are qualified
in their entirety by this cautionary statement, and Molecular
Insight undertakes no obligation to revise or update this news
release to reflect events or circumstances after the date hereof.
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