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NC 100100 [NUS], a biodegradable, polymer-coated, gas-filled microballoon, is an ultrasound contrast agent that is being developed by Nycomed Amersham Imaging (a part of Amersham, formerly Nycomed Amersham), as Sonazoid™, for cardiac perfusion, peripheral vascular imaging and liver lesions.1 In the third quarter of 2001, Nycomed Amersham changed its name to Amersham.
Nycomed Amersham Imaging and received an approvable letter from the US FDA for use of Sonazoid™ as an ultrasound contrast agent for cardiac function. However, the company decided not to pursue this initial indication and may focus its investigation on new indications including liver and cardiac perfusion. Phase IIb clinical trials for liver imaging were completed in Japan. Following the analysis of the data, Phase III clinical studies were initiated for both metastatic disease and hepatocellular carcinoma. In the USA and Europe, Phase IIb clinical trials with Sonazoid™ for detection of liver disease were also...
KeywordsMyocardial Perfusion Imaging Ultrasound Contrast Agent Cardiac Perfusion European Medicine Evaluation Agency Acute Coronary Occlusion
- 1.Towart R, Karlsson JOG, Moen O, et al. NC100100 has no negative effects on experimental infarct size in dogs. Naunyn- Schmiedeberg’s Arch Pharmacol 358 (Suppl 2): 616 (Poster), No. 1, 1998Google Scholar
- 2.Yao JF, Teupe C, Takeuchi M, et al. Quantitative 3-dimensional contrast echocardiographic determination ofmyocardial mass at risk and residual infarct mass after reperfusion: experimental canine studies with intravenous contrast agent NC100100. J Am Soc Echocardiogr 13: 570–581, Jun 2000PubMedCrossRefGoogle Scholar