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.
Scientists find new driver of ovarian cancer spread
A cell surface receptor known as F2R could serve as both a diagnostic marker for ovarian cancer...
Hormone therapy shifts body proteins to match gender identity
Researchers have discovered that gender-affirming hormone therapy can alter body proteins to...
Targeting 'molecular bodyguards' weakens prostate cancer cells
Research reveals that two enzymes — PDIA1 and PDIA5 — act as 'molecular...
