Agenix gets green light for Phase II trial
Monday, 18 October, 2004
Seven weeks after filing 5600 pages of Investigational New Drug application for a Phase II trial of its ThrombioView blood-clot imaging technology, Agenix [ASX: AGX, NASDAQ OTC: AGXLY] has been given the go-ahead by the US Food and Drug Administration.
The first four US clinical trial sites will now submit ThromboView to their respective Institutional Review Boards for approval to commence patient enrolment.
Agenix managing director, Don Home, said the clinical investigators expected the first patients to commence the Phase II trial within the next 8 to 12 weeks. The trial will involve an estimated 150 deep vein thrombosis (DVT) patients.
The Phase II trial is expected to be conducted in Canada and the US over 12 months, testing ThromboView against regulatory 'gold standards' for DVT and pulmonary embolism (PE). The current DVT gold standard is veinography and the PE standard is pulmonary angiography.
"We were very well prepared for the FDA's requirements. Our application was incredibly detailed, drawing on the results of the Phase Ia and Ib trials in Australia," Home said.
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