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.
Global study finds 250 genes linked to OCD
Researchers say they have found the genes linked to obsessive compulsive disorder (OCD), after...
TGA approves therapy for paediatric growth hormone deficiency
The TGA has approved SKYTROFA as a treatment for growth failure in children and adolescents aged...
Immune cell boost could enable lasting vaccine protection
A research team has found a promising new way to enhance the effectiveness of vaccines by tapping...
