Sonus Plans EchoGen NDA For Early 1995

Sonus Pharmaceuticals, a privately-held developer of ultrasound imaging agents based in Bothell, Washington, in the USA, plans to file a New Drug Application for its EchoGen contrast agent in the first quarter of 1995, according to president and chief executive Steven Quay. 45 patients have been enrolled to date in the two Phase II trials of the technology, which will eventually involve a total of 120 patients.

EchoGen is a liquid dodecafluoropentane emulsion that rapidly undergoes a phase shift to a gas at body temperatures. The emulsion forms highly echogenic micro-bubbles, which pass easily from the right side of the heart through the lung and left ventricle and into the myocardium to produce opacification. Sonus is initially seeking regulatory approval for two indications; to evaluate cardiac wall motion and myocardial perfusion and also to detect space filling lesions in abdominal organs, for example to differentiate between hemangiomas, nodular hyperplasia and hepatocellular carcinoma in the liver.

Dr Quay has been a leading figure in imaging research for many years. He founded Salutar (now Norwegian-owned Nycomed Salutar) in 1984 and is the sole inventor and patent holder of Omniscan, the first non-ionic magnetic resonance imaging contrast agent to reach the market. He has also recently been elected to the FDA's Radiological Devices panel.