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:
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1)
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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.
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2)
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This press release was reviewed and received clearance by the
Pharmaceutical Advertising Advisory Board (www.paab.com).
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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.
SOURCE Centre for Probe Development and Commercialization