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Molecular subtypes of lung cancer manifest as different diseases

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SAFE-BioPharma® Standard to be Highlighted at Molecular TriCon

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Molecular and Cellular Foundations of Medicine Class, 2 of 2 – Video

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Ronnie Andrews Joins Life Technologies as President, Medical Sciences

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CAMBRIDGE, MA–(Marketwire -02/02/12)- Molecular Insight Pharmaceuticals, Inc. (MIP) will present first human data on the molecular imaging of metastatic prostate cancer in bone and soft tissue with their new 99mTc-radiolabeled compounds. The data will be highlighted at a scientific poster presentation on February 3, 2012 at the ASCO-2012 Genitourinary Cancers Symposium in San Francisco, CA. 99mTc-MIP-1404 and 99mTc-MIP-1405, internally developed at Molecular Insight, are technetium-99m-labeled small molecules that target prostate specific membrane antigen (PSMA), a protein expressed at high levels in primary and metastatic prostate cancer. The data demonstrated that 99mTc-MIP-1404 and 99mTc-MIP-1405 rapidly detected both bone and lymph node lesions in 6 metastatic prostate cancer patients and in some cases demonstrated a greater number of metastatic lesions in bone than bone scans, the standard of care for imaging skeletal metastases. Neither compound localized in the normal prostate gland, and both cleared from the blood rapidly, allowing rapid visualization of disease.

Study Background: PSMA is a well-established molecular target for developing radiopharmaceuticals for imaging and therapy of metastatic prostate cancers. 99mTc-MIP-1404 and 99mTc-MIP-1405 are small molecule inhibitors of PSMA that exhibit high affinity for the extracellular domain of this protein. Preclinical studies demonstrated that 99mTc-MIP-1404 and 99mTc-MIP-1405 bind to PSMA with high affinity and localize in tumors rapidly. This study, reporting the first human data obtained from images of six men with metastatic prostate cancer and also six healthy male subjects, was designed to assess the pharmacokinetics and tumor localizing characteristics of 99mTc-MIP-1404 and 99mTc-MIP-1405.

Study Results: Under an exploratory IND, using a cross-over design, the pharmacokinetics, and tumor imaging characteristics of 99mTc-MIP-1404 and 99mTc-MIP-1405 were compared in 6 healthy volunteers and 6 men with a history of prostate cancer and radiographic evidence of metastatic disease. Whole body images were obtained at 10 minute, 1, 2, 4 and 24-hour time intervals and demonstrated rapid and persistent uptake of both compounds in the salivary, lacrimal, and parotid glands. Liver and kidney uptake was also evident, with greater uptake and retention with 99mTc-MIP-1404. Both agents cleared the blood in a biphasic manner, with 99mTc-MIP-1404 demonstrating significantly lower urinary activity (7%) compared to 99mTc-MIP-1405 (26%). In men with metastatic prostate cancer, both compounds rapidly localized to lesions in lymph nodes and bone as early as 1 hour post injection. SPECT/CT images at 4 and 24 hours demonstrated excellent lesion contrast with target-to-background ratios up to 28:1. Good correlation was seen with bone scans in most patients, though, in general, more lesions were visualized with 99mTc-MIP-1404 and 99mTc-MIP-1405 than bone scan, the standard of care for imaging bone metastases.

Study Conclusions: 99mTc-MIP 1404 and 99m Tc-MIP 1405 rapidly detected soft tissue lesions in prostate cancer patients in both enlarged and sub-centimeter lymph nodes, and in some cases identified a greater number of skeletal lesions than bone scan. Since 99m Tc-MIP-1404 has minimal activity in the bladder, further work is planned to correlate imaging findings with histopathology in patients with newly diagnosed and metastatic prostate cancer.

Dr. John W. Babich, President and Chief Scientific Officer of Molecular Insight, noted, “99mTc-MIP-1404 represents a novel approach to SPECT-imaging of prostate cancer by directly imaging disease using a small molecule that specifically binds to the external domain of PSMA. When combined with commonly available SPECT imaging, 99mTc-MIP-1404 has the potential of replacing current detection methods — bone scans, CT or MRI scans — that can't provide the same level of detail when staging men with prostate cancer, following the progression of the disease, or monitoring response to treatment. 99mTc-MIP-1404 may also have the potential of aiding in the planning of radiation therapy through improved disease visualization and ensuring that normal tissues are spared the damage that can occur with the use of external beam radiotherapy. Molecular Insight plans to focus development to provide a more sophisticated means of decision-making for the urologist, radiation therapist, and medical oncologist and to facilitate better and improved long-term patient outcomes.”

99mTc-MIP 1404 is scheduled to enter a multi-center Phase 2 study in Q3 2012.

Note: The abstract, Tc-99m Labeled Small Molecule Inhibitors of Prostate Specific Membrane Antigen (PSMA): New Molecular Imaging Probes to Detect Metastatic Prostate Adenocarcinoma (PCa), is available on the Company's website, www.molecularinsight.com, under the Molecular Medicine tab, Scientific Presentations.

About ASCO-GU
The 2012 Genitourinary Cancers Symposium offers attendees the opportunity to learn about the latest clinical and scientific strategies in screening, evaluation, and management of genitourinary cancers and help them understand how integrated cancer care can best be used to treat patients.

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

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Molecular Insight Pharmaceuticals, Inc. Presents Human Data Demonstrating Detection of Metastatic Prostate Cancer

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Peter Hans Hofschneider prize for Molecular Medicine 2011 for Hakkim_hd.mov – Video

Original post:
Paper denying HIV–AIDS link sparks resignation

HOPEWELL TOWNSHIP, N.J. & WAUKESHA, Wis.–(BUSINESS WIRE)–
Capital Health and GE Healthcare announced today the first
Discovery* NM 750b was installed at Capital Health’s New Jersey
Hopewell medical center. Capital Health is a central New Jersey
region leader in advanced medicine, with significant
investments in advanced technologies and its medical staff.

“We are very pleased to offer women in our community this new,
highly sophisticated, test that can help detect breast cancer
at its earliest stages, which, as we all know, can be critical
to the success of treatment,” said Al Maghazehe, president and
CEO of Capital Health. “We remain committed to bringing
patients in this region the latest technological advances to
enhance their healthcare options.”

“This innovative technology overcomes some of the challenges we
currently face with breast cancer detection, particularly in
women with dense breast tissue, and allows us to offer our
patients improved medical care,” said Dr. Yaakov Applbaum,
medical director of the Radiology Department at Capital Health.
“It will also be useful in the early detection of breast cancer
in women who are at a high risk for the disease.”

Breast cancer detection is sometimes difficult, as breast
density in varying degrees can overlap with lesions, making
them harder to find with traditional x-ray mammography; and
interpretation can vary among physicians, which can often lead
to recommendations for additional tests.

Molecular Breast Imaging, or MBI, is less susceptible to breast
density, since the method involves a radioactive tracer that
has a high affinity for metabolically active tumors, and two
specialized detectors imaging the breast from opposing angles.
MBI has been shown in clinical studies to outperform
mammography for early detection, and in finding more
cancers.1

The GE Discovery NM 750b scanner features dual detectors with
CZT technology. The system’s innovative detector design
facilitates increased imaging sensitivity compared to
conventional Nuclear Medicine “Gamma” cameras. In addition,
image contrast and quality represent significant improvements
over conventional systems. Imaging of the breast can be
performed with only light immobilization and without the need
of full compression. The Discovery NM 750b is intended to
become part of a comprehensive arsenal of advanced imaging
technologies that includes PET (Positron Emission Tomography),
Spiral CT and MRI (Magnetic Resonance Imaging).

“We believe that offering MBI with its ability to detect
certain cases of breast cancer earlier will make Capital Health
the premier destination in the area for breast cancer
diagnosis,” said Applbaum. “Molecular imaging is being added to
the already comprehensively equipped Woman’s Imaging Center at
Capital Health Medical Center – Hopewell, which includes two GE
digital mammography units, two GE LOGIQ* E9 Ultrasound
machines, and a 3Tesla Magnet for Breast MRI.”

*Trademark General Electric Company

About Capital Health:

Capital Health is the region’s leader in advanced medicine,
with significant investments in innovative technologies and
experienced physicians. Comprised of two hospitals in Mercer
County and the Capital Health -Hamilton outpatient facility,
Capital Health has three times received Magnet recognition for
nursing excellence. Capital Health is a growing healthcare
organization having just opened a new, state-of-the-art
hospital in Hopewell Township, N.J. and completed a significant
expansion of services at its Regional Medical Center in
Trenton.

ABOUT GE HEALTHCARE

GE Healthcare provides transformational medical technologies
and services that are shaping a new age of patient care. Our
broad expertise in medical imaging and information
technologies, medical diagnostics, patient monitoring systems,
drug discovery, biopharmaceutical manufacturing technologies,
performance improvement and performance solutions services help
our customers to deliver better care to more people around the
world at a lower cost. In addition, we partner with healthcare
leaders, striving to leverage the global policy change
necessary to implement a successful shift to sustainable
healthcare systems.

Our “healthymagination” vision for the future invites the world
to join us on our journey as we continuously develop
innovations focused on reducing costs, increasing access and
improving quality around the world. Headquartered in the United
Kingdom, GE Healthcare is a unit of General Electric Company
(NYSE:
GE –
News). Worldwide, GE Healthcare employees are committed to
serving healthcare professionals and their patients in more
than 100 countries. For more information about GE Healthcare,
visit our website at
www.gehealthcare.com.

For our latest news, please visit

http://newsroom.gehealthcare.com.

1 Rhodes D, Carrie B. Hruska, Stephan W. Phillips,
Dana H. Whaley, and Michael K.O’connor, Dedicated Dual-Head
Gamma Imaging for Breast Cancer Screening in Women with
Mammographically Dense Breasts, Radiology 100625; Published
online November 2, 2010, doi 10.1148/radiol.10100625

Read the original:
Capital Health Will be First in U.S. to Offer GE Molecular Breast Imaging

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Newly discovered molecular pathway may explain how AML develops

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Jak of all trades? Not of leukaemia therapy!

Canadian centre of excellence partners with US-based Molecular
Insight Pharmaceuticals to manufacture a new
radiopharmaceutical for clinical trials that will evaluate the
potential to deliver targeted radiotherapy directly to
metastatic prostate cancer.

HAMILTON, ON, and CAMBRIDGE, MA, Jan. 30, 2012 /PRNewswire/ – A
new targeted radiopharmaceutical, designed to deliver a
therapeutic dose of radiation directly to metastatic prostate
cancer, will be manufactured in Hamilton, Ontario to be used in
clinical trials that will evaluate its efficacy and benefits
for patients. The radiopharmaceutical, I-131-MIP-1466, will be
manufactured by the Centre for Probe Development and
Commercialization (CPDC, Hamilton, ON), for the developer of
the compound, US-based Molecular Insight Pharmaceuticals
(Molecular Insight, Cambridge, MA). The trial, anticipated to
start in early 2013, will mark the first time that a
small-molecule-based radiopharmaceutical specifically targeting
prostate-specific membrane antigen (PSMA), a type of protein
expressed in high levels on prostate tumours, will be tested
for its ability to treat prostate tumours that have spread
throughout the body.

According to the World Health Organization, prostate cancer is
the most common cancer affecting North American men. Nearly 95%
of primary prostate tumours are curable using radiation therapy
if detected and treated in the earliest stages; however,
treatment is much less successful when the disease spreads
beyond the prostate gland. The introduction of a targeted
treatment method, that could selectively deliver high doses of
radiation to tumours that have spread throughout the body, has
the potential to open new options for treating metastatic
prostate disease.

Dr. John W. Babich, President and Chief Scientific Officer of
Molecular Insight Pharmaceuticals, noted, “As we prepare to
enter clinical trials with our novel small molecule platform
for targeting prostate cancer, we sought a manufacturing
partner that could meet our demanding standards and timelines.
We selected CPDC because of the Centre's outstanding quality
assurance program and proven reliability in rapidly achieving
robust GMP manufacturing standards. In CPDC we are seeking a
manufacturing partner that can deliver the highest quality
radiopharmaceutical for our clinical trial needs and one that
has the ability to expand as our program develops.”

“One of CPDC's primary goals is to attract new technologies and
investment to Canada's rapidly growing medical imaging and
radiopharmaceutical markets and to create jobs in
groundbreaking, high-impact areas in the life sciences,” said
Dr. John Valliant, CEO and Scientific Director of CPDC. “Our
capacity to innovate, dedication to quality and ability to
deliver outstanding customer service has enabled us to work
with companies like Molecular Insight and play an important
part in advancing new technologies for the diagnosis and
treatment of cancer. This partnership, demonstrates how CPDC's
unique capabilities help to build bridges between academic
programs and the private sector to support Ontario's strengths
in imaging and probe development.”

CPDC, a not-for-profit Centre of Excellence for
Commercialization and Research (CECR), has grown to be a leader
in the discovery, development and manufacturing of
radiopharmaceuticals. The Centre has introduced several new
radiopharmaceuticals to Ontario that are now being used in
clinical trials to diagnose and stage various cancers and to
monitor patient response in chemotherapy trials.

Molecular Insight continues its pioneering efforts in molecular
medicine.  In its work to date, Molecular Insight has
demonstrated the ability of small radiolabeled molecules to
target PSMA. While prostate-specific-antigen (PSA) screening
has become the primary tool for the detection of prostate
cancer, this blood test provides no information about the
location and extent of the disease.  New imaging methods
that will more accurately diagnose and stage metastatic
prostate cancer, as well as monitor progression and response to
therapy, should enable improved patient management, including
treatment selection and planning.  Molecular Insight
believes it can offer a more sophisticated means of decision
making for the oncologist, which should translate to better
patient outcomes.  Molecular Insight has diagnostic
radiopharmaceuticals currently in clinical development for
visualizing metastatic prostate cancer, which have yielded
high-quality images of lymph node and bone lesions in prostate
cancer patients.  I-131-MIP-1466 is a therapeutic analog
of these diagnostic compounds and is radiolabeled with I-131 to
enable targeted radiotherapy.  Molecular Insight has
demonstrated in preclinical models that I-131-MIP-1466 inhibits
tumour growth in human prostate cancer xenografts.  The
next step is to file an Investigational New Drug application
with the FDA in preparation for the initiation of a clinical
trial.

NOTES:

1)    

The safety and efficacy of the radiopharmaceuticals
mentioned in this press release are still under
investigation. Market authorization in Canada and United
States has not yet been obtained.

2)   

This press release was reviewed and received clearance by
the Pharmaceutical Advertising Advisory Board (www.paab.com).

About Centre for Probe Development and Commercialization
(CPDC):

CPDC discovers, develops and distributes molecular imaging
probes for the early diagnosis of diseases and to assess the
effectiveness of treatments. An important part of Ontario's
health system, CPDC provides a reliable, daily supply of
imaging probes to hospitals across the province. CPDC also
works collaboratively with industry and academic partners,
offering the research, manufacturing and regulatory expertise
needed to move innovative probe technology and new therapeutic
drugs from R&D labs to clinical use. CPDC is a Centre of
Excellence for Commercialization and Research, part of the
Networks of Centres of Excellence Program, and is supported by
the Ontario Institute for Cancer Research, GE Healthcare,
Cancer Care Ontario, VWR, and McMaster University. To learn
more, visit CPDC at
www.imagingprobes.ca.

About Molecular Insight Pharmaceuticals

Molecular Insight Pharmaceuticals is a clinical-stage
biopharmaceutical company and pioneer in molecular medicine.
The Company is focused on the discovery, development, and
commercialization of radiopharmaceuticals for molecular imaging
and targeted radiotherapy of cancer with particular emphasis on
unmet clinical needs in prostate cancer imaging and therapy.
For further information, please visit the Company's website:

www.molecularinsight.com.

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Radiopharmaceutical for Targeted Treatment of Prostate Cancer to Enter Clinical Trials

]

Contact: Dr. Samuli Ripatti
samuli.ripatti@fimm.fi
358-206-108-159
University of Helsinki

In a study to the genetic variance of human metabolism,
researchers have identified thirty one regions of the genome
that were associated with levels of circulating metabolites,
i.e., small molecules that take part in various chemical
reactions of human body. Many of the studied metabolites are
biomarkers for cardiovascular disease or related disorders,
thus the loci uncovered may provide valuable insight into the
biological processes leading to common diseases.

Laboratory tests used in the clinic typically monitor one or
few circulating metabolites. The researchers at the Institute
for Molecular Medicine Finland (FIMM) used a high throughput
method called nuclear magnetic resonance (NMR) that can measure
more than hundred different metabolites in one assay. This
provides a much more in-depth picture of circulating metabolic
compounds.

“Using this extensive analysis in thousands of people, we could
identify a large number of genetic loci regulating the level of
compounds circulating in the blood stream”, says Dr. Samuli
Ripatti, the leader of the study.

The team assayed 117 detailed metabolic markers, including
lipoprotein subclasses, amino acids and lipids, and conducted
the largest genome-wide association analysis of this type, in
terms of study sample size of 8330 individuals from six Finnish
population-based cohorts and 7.7 million genomic markers
studied. They revealed, in total, 31 genetic regions associated
with the blood levels of the metabolites.

Eleven of the loci had not been previously shown to be
associated with any metabolic measures.

Among the findings were two new loci affecting serum
cholesterol subclass measures, well-established risk markers
for cardiovascular disease, and five new loci affecting levels
of amino acids recently discovered to be potential biomarkers
for type 2 diabetes. The discovered variants have significant
effects on the metabolite levels, the effect sizes being in
general considerably larger than the known common variants for
complex disease have.

Also, using Finnish twin pair samples, the researchers
indicated that the metabolite levels show a high degree of
heritability. “This result suggests that the studied
metabolites are describing better the underlying biology than
the routinely used laboratory tests. Therefore, the study
provides further support for the use of detailed data on
multitude of metabolites in genetic studies to provide novel
biological insights and to help in elucidating the processes
leading to common diseases”, Dr. Ripatti says.

###

Dr. Samuli Ripatti is a FIMM-EMBL Group Leader at the Institute
for Molecular Medicine Finland (FIMM), University of Helsinki,
Finland (http://www.fimm.fi)
and a Honorary Faculty Member at the Wellcome Trust Sanger
Institute, UK (http://www.sanger.ac.uk)

The Institute for Molecular Medicine Finland FIMM is an
international research institute focusing on building a bridge
from discovery to medical applications. FIMM investigates
molecular mechanisms of disease using genomics and medical
systems biology in order to promote human health. FIMM is a
multi-disciplinary institute combining high-quality science
with unique research cohorts and patient materials, and
state-of-the-art technologies. Website http://www.fimm.fi

The Wellcome Trust Sanger Institute is one of the world's
leading genome centres. Through its ability to conduct research
at scale, it is able to engage in bold and long-term
exploratory projects that are designed to influence and empower
medical science globally. Institute research findings,
generated through its own research programmes and through its
leading role in international consortia, are being used to
develop new diagnostics and treatments for human disease.
Website http://www.sanger.ac.uk/

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