99mTc-EC-DG

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The first radiodiagnostic product based on EC Technology will be 99mTc - labeled deoxyglucose ('99mTc-EC-DG'), a universal metabolic imaging agent that can diagnose hyper cellular activity in cancer cells. It will be the first 99mTc labeled sugar analogue developed for use in functional imaging. The only universal metabolic imaging agent in current use is FDG which requires a cyclotron to produce the positron emitting radioisotope fluorine-18 (18F) and the use of an expensive PET camera to acquire the images.99mTc-EC-DG will be made available in a 'shake and shoot' cold kit which will simplify and reduce the preparation time for administration of the agent. 99mTc is a readily available radioisotope (can be cost effectively produced on-site with a 99mMo-generator), has a six hour half-life, is imaged on a standard SPECT (gamma) camera, yields 73% lower radio-active energy than 18F and will give the radiologist or radiation oncologist the flexibility to perform staged or time phased imaging. The patient cost of a 99mTc-EC-DG imaging procedure should be appreciably less than the the cost of a FDG-PET procedure.

The Phase I clinical trial study for 99mTc-EC-DG was conducted at M.D. Anderson Cancer Center. The clinical study involved imaging patients with laryngeal squamous cell carcinoma and patients with primary lung cancer by comparing 99mTc-EC-DG scans with 18 F-FDG-PET scans. The company is preparing to move forward with a combination Phase II/III clinical trial study in the fourth quarter of 2005. The study will address non-Hodgkin's lymphoma, non-small cell lung cancer and metastatic cancer at six medical institutions across the U.S. and Canada. 99mTc-EC-DG differentiates between inflammation and the lesion in patients with lymphoma. This is due to the ability of EC-DG to get into the cell nucleus and translocate into the cell's DNA. Please note the images (below) from a lymphoma study conducted in Shanghai, China which compared 99mTc-EC-DG with 18F-FDG-PET. The 18F-FDG-PET images are unable to identify the precise location of the lesion within the area of the patient's arm pit due to the amount of inflammation present (which is often the case). The 99mTc-EC-DG images reveal only the lesion without being obscured by the inflamed tissue surrounding and masking the lesion.

In addition, 99mTc-EC-DG is being evaluated as a functional imaging agent for use in cardiac imaging. The company is preparing to commence a canine study at the University of Virginia in the late third or early fourth quarter 2005.

FDG images (top 3 slides) show large areas of inflammation which are obscuring the location of the tumor. Also note the high uptake of FDG in the brain. The EC-DG images (bottom 3 slides) depict the location of the tumor and do not illuminate the inflammation surrounding the tumor site.

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Terry Colip

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