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GE healthcare initiates clinical trials for first-ever PET Imaging agent to track Angiogenesis in cancer

AZDEL : 12 September, 2007  (Company News)
GE Healthcare, a division of the General Electric Company, announced today that it has initiated a first-in-man clinical study designed to validate information provided by a molecular imaging agent in evaluating the extent and nature of cancer. Specifically, this proprietary positron emission tomography agent has a biological mechanism to track the process of angiogenesis, the formation of new blood vessels in the body.
The body naturally forms new blood vessels during wound healing. However, angiogenesis is also necessary for the growth of many tumors beyond a certain size, as a cancerous tumor will recruit blood vessels in order to sustain accelerated growth.

A molecular imaging agent that binds to the process of angiogenesis in the body could help physicians identify the location and growth patterns of tumors. Imaging the angiogenic process at the molecular level could also enable researchers and clinicians to monitor the effectiveness of anti-angiogenic cancer drugs and patient response to drug therapy.

The molecule discovered by GE being studied in this clinical trial is a radiolabeled small peptide in a configuration that allows high affinity binding of the peptide to specific integrin receptors including aVB3. Integrins are associated with endothelial cell differentiation, proliferation, migration and attachment to the extra-cellular matrix, which are critical during angiogenesis. Integrin receptors have limited tissue distribution with high levels of expression achieved during tumor growth, invasion and metastasis.

The trial, overseen by David Brooks, MD, chief medical officer at GE IMANET is currently enrolling subjects at the Hammersmith Hospital in London. This imaging agent will be used to quantify response to therapy by imaging Stage IV metastatic tumors of the breast before and after cycles of chemotherapy. 'Angiogenesis is a characteristic process of many cancers, and we're excited to participate in this clinical trial, which may provide additional validation for the use of this novel molecular imaging agent in oncology applications,' said Brooks. 'Data from this program could establish a new measurement used to assess the effectiveness of treatment approaches in cancer.'

Angiogenesis is one of the most promising areas of anti-cancer research, with more than USD 4 billion invested in the research and development of angiogenesis-based medicines, making this one of the most heavily funded areas of medical research in history. More than 60 anti-angiogenesis drugs are currently in clinical trials.

'Our vision is that one day clinicians will be able to detect the progression of cancers at an earlier stage, allowing rapid intervention, which can be monitored for effectiveness and adjusted quickly to compensate for any lack of response,' says Don Black, head of research and development at GE Healthcare's Medical Diagnostics division. 'We're using our unique capabilities in biology and engineering to develop imaging agents across all modalities that provide groundbreaking molecular diagnostic options. We're planning to utilize our synthesis platform for multi-site clinical trials and we're looking forward to collaborating with the pharmaceutical industry to enable more targeted therapies and better results for patients.'

GE is planning to use its proprietary FASTlab synthesis platform for multi-site clinical trials and commercial production of this agent. This technology features a single-use cassette that contains pre-measured quantities of all chemicals needed for the synthesis of radiopharmaceuticals used by technicians in commercial and research radiopharmacies. FASTlab cassettes require virtually no assembly and easily snap into the synthesis module. Strictly controlled and consistent production of PET tracer candidates at each clinical site is essential and this is a cassette based synthesis system that is not limited to a single tracer molecule, and accelerates the set up and execution of these trials. GE Healthcare's goal is to make innovative tracers available to patients and doctors as soon as possible.
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