Andaris Quantison U.S. Phase II trial for myocardial perfusion imaging IND filed.

ANDARIS QUANTISON U.S. PHASE II TRIAL TO ASSESS MYOCARDIAL PERFUSION as well as left ventricular opacification, the Nottingham, U.K.-based biotech company said. Andaris announced July 31 that it has filed an IND for its ultrasound contrast agent Quantison, a three-micron air-filled albumin microcapsule. The Phase II trial will begin as soon as possible following FDA clearance, the company said.

"Ultrasound contrast agents currently on the market or in registration have concentrated on left ventricular opacification," Andaris noted. Using Quantison for myocardial perfusion imaging would "allow more valuable, and previously unavailable, information on ischemic areas and areas at risk to be obtained," the company maintained.

European Phase III trials of Quantison for cardiac imaging are expected to begin by year end, the company said. A Phase II study of Quantison for use in renal imaging in patients with hypertension resulting from renal artery stenosis began in April in Rotterdam.

Quantison cardiac imaging studies in Europe have enrolled 150 patients in Phase I and Phase II trials. Andaris said that it has amassed enough safety data in Europe to proceed directly to Phase II in the U.S.

Andaris has a longer-acting imaging agent, Quantison Depot, in preclinical studies. Quantison Depot is a 10-micron albumin microcapsule for cardiac imaging that must be injected directly into the coronary artery and is intended for use in catheterized patients.

Andaris was formed through a 1994 management buyout of the microcapsule division of Delta Biotechnology. Delta Biotechnology was a subsidiary of Ohmeda at the time, but was purchased in 1996 by Centeon.

Andaris CEO David Heath was formerly managing director of Delta Biotechnology. Terence Chadwick, director of development and chief medical officer, joined in February 1997 from Rhone-Poulenc Rorer, where he was VP-corporate medical affairs. The imaging program is headed by Richard Johnson, PhD, a biochemist who managed microencapsulation R&D at Delta Biotechnology prior to the spin-off.

Gist-Brocades has provided continuing funding for Andaris operations "in exchange for an increasing share of the equity," the company reported. Andaris continues to be privately held.

Andaris is not named in litigation on ultrasound contrast agent patents filed by Molecular Biosystems and Mallinckrodt at the end of July. Andaris' products are not perfluorocarbon-based, the company explained, unlike the other ultrasound imaging agents in development in the U.S.