CAMBRIDGE, MA -- 08/07/09 --
Molecular Insight Pharmaceuticals,
Inc. (NASDAQ: MIPI) today announced that it has initiated a pivotal
Phase 2 clinical trial for Azedra(TM) (Ultratrace(TM) Iobenguane I 131),
its lead oncology candidate for the treatment of malignant
pheochromocytoma, a type of neuroendocrine cancer. The
single-arm trial will evaluate the efficacy and safety of Azedra in adult
patients with malignant relapsed/refractory pheochromocytoma and position
Molecular Insight to file a New Drug Application (NDA).
Azedra has been designated as an Orphan Drug with Fast Track status by the
U.S. Food and Drug Administration.
Pheochromocytoma tumors are
usually found in the adrenal glands, but may arise in other areas of the
body. For malignant pheochromocytoma, radiation therapy offers short-term
symptomatic relief, but no cure. Chemotherapy trials have failed to
produce cures or significant remissions. For patients with this malignant
disease, for whom surgery is not an option, the five-year survival rate is
less than 50 percent.
Azedra is a targeted radiotherapeutic, which consists of the known
iobenguane I 131 molecule (commonly known as I-131-MIBG) radiolabeled using
the Company's proprietary Ultratrace technology. If successful, Azedra
would be the first anti-cancer therapy in the United States indicated for
the treatment of pheochromocytoma. Molecular Insight also is developing
Azedra for the treatment of neuroblastoma, a type of
neuroendocrine cancer in children.
Daniel L. Peters, President and Chief Executive Officer of Molecular
Insight, said, "The launch of this trial marks a significant milestone for
our Azedra program, which addresses the clear need for new treatment
options for pheochromocytoma. Azedra is a promising candidate. This
targeted radiotherapeutic demonstrated high tumor uptake in preclinical
studies and favorable pharmacokinetics in completed trials. Azedra's
development underscores Molecular Insight's commitment to apply innovative
approaches to address unmet patient needs."
In March 2009, Molecular Insight received Special Protocal Assessment
approval from the U.S. Federal Drug Administration (FDA) for the Phase 2
trial. Azedra trial IB-12B will be conducted in 58 adults (evaluable) with
pheochromocytoma with an expected enrollment of about 75.
Pheochromocytoma tumors cause excess release of the hormones epinephrine
and norepinephrine, producing adverse and often severe effects on a
patient's heart rate and blood pressure. The primary endpoint of the study
will be Azedra's ability to reduce the need for anti-hypertensive
medications required to treat the elevated blood pressure often seen as a
key sign of the cancer. This trial has begun at centers in the United
States and ultimately will include sites in Western Europe.
John W. Babich, Ph.D., Molecular Insight's Executive Vice President, Chief
Scientific Officer and President of Research and Development, said,
"Molecular Insight is combining an already commercialized molecule with our
proprietary Ultratrace radiolabeling technology. We believe that the
Ultratrace technology platform enables us to maximize the therapeutic value
of Azedra by eliminating unnecessary cold contaminants, or non-radioactive
iobenguane, which provide no therapeutic benefit. The absence of cold
contaminants allows greater tumor concentration of Azedra and reduced side
effects related to the drug's administration."
MDS Nordion to Supply Azedra
Molecular Insight also announced that it has contracted with MDS Nordion,
Ottawa, Ontario, Canada, to manufacture and supply Azedra for late-stage
clinical trials and, upon FDA approval, for commercial use. A section of
MDS Nordion's existing Ottawa facility will be dedicated to the manufacture
of Azedra and designed to comply with FDA and European Medicines Agency
requirements for the aseptic manufacture of radiopharmaceuticals.
About Azedra
Azedra recognizes a unique molecular target over-expressed on the surface
of certain neuroendocrine cancer cells, which enables the drug to be
accumulated selectively by the tumor. Azedra, developed using Molecular
Insight's proprietary Ultratrace technology, is designed to maximize the
delivery of iobenguane I 131 molecules to targeted neuroendocrine tumors
and to enable safe and effective treatment while minimizing the amount of
non-radioactive iobenguane molecules administered to the patient. Azedra
is based on iobenguane I 131, a radiotherapeutic currently marketed in
Europe for treating several types of neuroendocrine cancers.
Azedra is one of two clinical-stage oncology candidates that Molecular
Insight is developing for the treatment of neuroendocrine tumors. The
Company also is developing Onalta(TM) (90Y-edotreotide), a radiolabeled
somatostatin analog, initially for the treatment of pancreatic
neuroendocrine and carcinoid tumors whose symptoms are not controlled by
conventional somatostatin analog therapy.
About Molecular Insight Pharmaceuticals, Inc.
Molecular Insight Pharmaceuticals (NASDAQ: MIPI) is a Cambridge,
Massachusetts-based biopharmaceutical company focused on the discovery and
development of innovative radiopharmaceuticals in the emerging field of
molecular medicine. These novel radiopharmaceuticals will provide
important improvements in disease detection and enable the delivery of
radiation therapy to widespread metastatic cancers. The Company has
focused the initial applications of its proprietary technologies in the
areas of cardiology and oncology. Molecular Insight's lead molecular
imaging radiopharmaceutical product candidate, Zemiva(TM), is being
developed for the diagnosis of cardiac ischemia, or insufficient blood flow
to the heart. The Company's imaging candidate, Trofex(TM), is in
development for the detection of metastatic prostate cancer. Molecular
Insight's lead molecular radiotherapeutic product candidates, Azedra(TM),
Onalta(TM), and Solazed(TM), are being developed for detection and
treatment of cancer. In addition, the Company's discovery efforts continue
to identify early-stage candidates -- a product of its in-house scientific
expertise and the application of its proprietary platform technologies.
For more information, visit http://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 development of Azedra(TM), Onalta™,
Zemiva™, Trofex™, Solazed(TM) and our other product candidates. 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.
Contact:
Deborah S. Lorenz
Senior Director
Investor Relations and Corporate Communications
Molecular Insight Pharmaceuticals, Inc.
(617) 871-6667
dlorenz@molecularinsight.com
