Healthcare Industry News:  radiopharmaceuticals 

Devices Diagnostics Oncology Radiology

 News Release - June 5, 2006

GE Healthcare Initiates Clinical Trials for First-Ever PET Imaging Agent to Track Angiogenesis in Cancer

Company Seeks to Accelerate Diagnosis of Cancer and Track Effectiveness of Therapies

CHALFONT ST GILES, England--(HSMN NewsFeed)--June 5, 2006--GE Healthcare, a division of the General Electric Company (NYSE:GE ), 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 (PET) 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.

Notes to the editor:

PET scans create physiological images of chemical changes, such as sugar metabolism, which occur in tissue. In PET, a patient is typically injected with a small amount of radiopharmaceutical that releases positrons (i.e. the anti particle of the electron) which are absorbed in tissue, releasing two gamma rays at 180 degrees apart. This unusual physical phenomenon makes PET imaging a much more accurate method for the detection and localization of disease, often at an early stage.

The radiopharmaceutical mostly used for clinical PET imaging currently is fluorine-18 2- fluoro-2-deoxyglucose ((18F)-FDG), whose uptake reflects glucose metabolism. FDG follows the same metabolic pathway as glucose. It is trapped in the cell where it accumulates at a rate proportional to glucose utilization. The accumulation of FDG is increased in tumor cells because of the higher metabolic rate. The higher FDG accumulation in tumors compared to normal tissue provides the basis for a high tumor-to-background ratio, which allows the detection and characterization of cancer. (18F)-FDG imaging is not completely specific to malignant tumors: inflammation, tuberculosis and certain non-malignant tumors also have increased uptake.

An approach to develop more functionally targeted molecular imaging PET agents like GE Healthcare's PET angiogenesis 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 drugs and patient response to cancer therapy.

GE Healthcare's Medical Diagnostics R&D team creates novel diagnostic imaging agents that are used during medical scanning procedures to highlight organs and tissues inside the human body, for the early detection, diagnosis and management of disease. Research efforts are currently focused on the unmet medical needs in neurology, oncology, and cardiology, with an emphasis on functional and molecular imaging agents that help doctors evaluate the physiology of disease and make treatment decisions earlier with confidence.

Imanet(TM) is GE Healthcare's international network of leading imaging research centers (www.imanet.com). It's business is to provide pharmaceutical and biotech companies with imaging solutions to accelerate and facilitate the discovery and development of novel therapeutics. Imanet uses PET, a quantitative imaging technology which provides information on biochemical and physiological processes and drug-receptor interactions at a molecular level. In PET research, Imanet today comprises Hammersmith Imanet, formerly the MRC Hammersmith Cyclotron Unit, London, UK; Uppsala Imanet, formerly Uppsala University PET Centre, Uppsala, Sweden and Turku Imanet, formerly the contract research arm of the Turku PET Centre, Turku, Finland.

About GE Healthcare

GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform and treat disease, so their patients can live their lives to the fullest.

GE Healthcare's broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases, and other conditions earlier. Our vision for the future is to enable a new "early health" model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the United Kingdom, GE Healthcare is a USD 15 billion unit of General Electric Company (NYSE: GE ). Worldwide, GE Healthcare employs more than 43,000 people 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.


Source: GE Healthcare

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