Radiopharmaceutical for Targeted Treatment of Prostate Cancer to Enter Clinical Trials

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 /CNW/ - 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.