Molecular Insight Pharmaceuticals Presents Azedra(TM) 12-Month Efficacy Data From Phase I Clinical Trial in

CAMBRIDGE, MA, Oct 05 (MARKET WIRE) --
Molecular Insight Pharmaceuticals, Inc. (NASDAQ: MIPI) today reported
one-year follow-up data from a Phase I dose-escalation clinical study of
Azedra(TM) demonstrating a positive safety profile and durable objective
tumor responses in patients with neuroendocrine cancers, pheochromocytoma
and paraganglioma. The study was designed to evaluate the safety and
identify the maximum tolerated dose (MTD) of Azedra, as well as to
collect clinical data on efficacy. These data were presented on October
2, 2009, at the North American Neuroendocrine Tumor Society (NANETS) 2009
Neuroendocrine Tumor Symposium in Charlotte, North Carolina. Azedra
(Ultratrace(TM) iobenguane I 131) is Molecular Insight's lead oncology
targeted radiotherapeutic using the Company's proprietary radiolabeling
technology platform.

In 12-month data reported today, a single dose of Azedra was shown to be
well tolerated by patients, and toxicities were predictable and
manageable. Additionally, Azedra demonstrated clinical benefit,
stabilizing or reducing tumor volumes in a majority of patients.
Twenty-one patients were treated at escalating dose levels from 6 to 9
mCi/kg. Objective tumor response according to Response Criteria in Solid
Tumors (RECIST) was obtained every three months. Best confirmed overall
response per RECIST was partial response (PR) for three patients (14%),
stable disease for 14 (67%), progressive disease for two (10%), and not
evaluable for two (10%) who had no follow-up scans. All three patients
with PR demonstrated this response at the first post-therapy visit at
three months and sustained the response through 12 months.

"Currently, there are no approved treatments in the United States for
patients with metastatic neuroendocrine tumors, so a targeted
radiotherapeutic such as Azedra that could provide a more potent,
effective therapy would be a significant therapeutic advancement,"
commented R. Edward Coleman, M.D., of Duke University Medical Center, an
author and investigator on the study. "These results at one year after
therapy demonstrate that Azedra therapy may potentially benefit many
patients who have metastatic pheochromocytoma or paraganglioma."

Data reported today provide long-term confirmation of preliminary Phase I
clinical findings presented at the 2008 American Society of Clinical
Oncology (ASCO) Annual Meeting. In June 2009, Molecular Insight
Pharmaceuticals initiated a single-arm, pivotal Phase 2 clinical trial for
Azedra for the treatment of malignant pheochromocytoma under a Special
Protocol Assessment (SPA) by the U.S. Food and Drug Administration (FDA).
In addition, Azedra has been granted Orphan Drug designation and Fast
Track status by the FDA. Under these programs, Molecular Insight plans to
file a New Drug Application (NDA) based on the Phase 2 data and
anticipates expedited FDA review of its application.

Phase I Study Overview

The Phase I dose-escalation study was designed to identify the maximum
tolerated dose (MTD) of Azedra and to evaluate the safety and efficacy in
patients with pheochromocytoma/ paraganglioma. The study results reported
today support a maximum tolerated dose of 8 mCi/kg (maximum 600 mCi).
Related adverse events were primarily hematologic or gastrointestinal, as
expected.

Patient evaluations were scheduled at 3, 6, 9, and 12 months. Long-term
follow-up will continue every six months through 5 years after treatment
with Azedra. In addition to RECIST criteria, other efficacy evaluations
included tumor biomarker response. Hypertension measurement was performed
as part of safety evaluations and anti-hypertensive medication taper,
discontinuation or changes were not a pre-specified endpoint in this
study. Since hypertension typically occurs in more than 90 percent of
pheochromocytoma/paraganglioma patients, changes in anti-hypertensive
medication from baseline use, as a measure of clinical benefit and tumor
response, were also evaluated.

While tumor markers in these patients are known to show frequent and
considerable variability in values, many patients with elevated baseline
tumor markers showed decreases, with many having normalization of these
levels at a post-therapy visit that was consistent with preliminary
findings reported previously [ASCO, 2008]. For example, at six months
post-therapy, vanillylmandelic acid levels were normalized or decreased by
at least 50% for four of the 11 evaluable patients with elevated baseline
values. Furthermore, five of 15 (33%) patients on anti-hypertensive
medications at time of therapy reduced or discontinued use of these
medications following treatment.

Significant side effects observed in the trial were thrombocytopenia,
neutropenia, dry mouth, salivary gland pain, nausea, vomiting, fatigue and
anorexia. The dose-limiting toxicities were neutropenia (2), febrile
neutropenia (1), and thrombocytopenia (1). Two patients died within the
12-month efficacy follow-up (hepatic failure, pulmonary embolism), while
three died during long-term follow-up; all deaths were considered by the
study investigator to be unrelated to Azedra. In this study, the drug
demonstrated favorable dosimetry and a predictable safety profile at all
doses tested. Per protocol, 8 mCi/kg (maximum 600 mCi) was confirmed as a
tolerable dose in adult patients with pheochromocytoma.

For the study abstract, please visit the Company's website:
http://www.molecularinsight.com/MolecularMedicine/ScientificPosters.aspx

Neuroendocrine Tumors

Neuroendocrine Tumors (NETs) are rare tumors of the nervous and endocrine
systems. Until becoming metastatic, they are typically slowly growing and
difficult to diagnose. Functional NETs secrete excess hormone, leading to
a variety of clinical syndromes, some life threatening and all adversely
affecting quality of life.

Pheochromocytomas are NETs that arise from sympathetic nervous system
cells in the adrenal gland and often produce catecholamines, resulting in
hypertension and other signs and symptoms in many patients. Extra-adrenal
pheochromocytomas are called paragangliomas. Approximately 10-15% of
patients with pheochromocytoma (pheo)/paraganglioma (para) develop
malignant disease with some reports noting >30% of pheos as being
malignant. The five-year survival rate for malignant pheo is reported at
50% while patients with metastatic pheochromocytoma have a five-year
survival reported between 20-60% with an average of about 35%. Prognosis
is worse in patients with metastatic liver or lung lesions where survival
is usually less than 2 years. No treatments for pheo/para have been
approved in the United States for these rare tumors.

About Azedra and Molecular Insight Pharmaceuticals' Oncology Pipeline

Azedra recognizes this norepinephrine transporter molecular target that is
over-expressed in neuroendocrine tumor cells allowing targeted
accumulation at these tumor sites. Azedra, developed using Molecular
Insight's proprietary Ultratrace(TM) technology, which permits more
efficient and high specific activity labeling with the therapeutically
active Iodine-131 isotope, permits maximum delivery of the therapeutic
potential of iobenguane I 131, a radiotherapeutic currently marketed in
Europe to treat neuroendocrine tumors. At a given therapeutic dose,
Azedra -- high specific activity 131 iobenguane -- minimizes the amount
of non-radioactive iobenguane molecules administered to the patient,
thereby reducing pharmacologic toxicities, especially cardiovascular
events or toxicity, and enabling safe, better tolerated and effective
treatment.

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 is a clinical-stage biopharmaceutical
company and is a pioneer in the emerging field of molecular medicine. The
Company is focused on the discovery and development of targeted
therapeutic and molecular imaging radiopharmaceuticals, primarily for use
in oncology. Molecular Insight has five clinical-stage candidates in
development. The lead oncology candidate, Azedra(TM), is currently in a
pivotal trial for pheochromocytoma. Onalta(TM) is being developed for the
treatment of carcinoid and other neuroendocrine tumors, Solazed(TM) for
treatment of malignant metastatic melanoma, and Trofex(TM) for detecting
metastatic prostate cancer. Zemiva(TM) is being developed for the
diagnosis of acute myocardial ischemia. 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 potential therapeutic benefit of
Azedra, our planned filing of a New Drug Application for Azedra, the
timing of FDA review of such application, our corporate strategy, the
development of Zemiva(TM), Trofex(TM) , Azedra(TM), Onalta(TM),
Solazed(TM) and our other product candidates, our programs in pivotal
trials and anticipated regulatory requirements,. 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 http://www.sec.gov/. Press
releases for Molecular Insight Pharmaceuticals, Inc. are available on our
website: http://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:
Investors
Charles H. Abdalian, Jr.
Vice President of Finance
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
(845) 638-6290
(201) 923-2049
spietropaolo@bccpartners.com

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