Agenix's Thromboview found safe
Monday, 20 June, 2005
Brisbane Agenix (ASX:AGX, OTC(NASDAQ):AGXLY) has found that its Thromboview blood clot diagnostic is safe and not associated with an immune response, according to results from its Phase Ib deep vein thrombosis (DVT) study.
Agenix has moved Thromboview into larger Phase II trials based on the results of the Phase Ib study.
The trial, which studied 26 people diagnosed with DVT, was aimed at safety, however, Agenix found positive results relating to the image quality of Thromboview.
The study found that 96.2 per cent of images were judged to be of either 'good' or 'fair' quality, although only three rating alternatives were provided -- 'good', 'fair' or 'poor'.
It also found that for the 3.8 per cent of images judged to be of 'poor' quality, the most frequent reason given was insufficient radioactivity counts in the image.
The trial also found that no one dose level provided any advantage over others and subsequent trials will evaluate only the lowest dose of Thromboview.
"The DVT images showed that Thromboview was able to specifically bind and visualise clots," said Agenix Scientific Advisory Board Chairman Prof Paul Eisenberg.
Whilst primarily a DVT study, 18 patients had images taken of their lungs to provide data on blood clots, since DVTs may break of to form pulmonary emboli (or clots in the lungs).
The study found that 16 of 18 lung images were of 'good' quality and Agenix is now recruiting for a Phase Ib study to assess the safety of Thromboview in patients with PE as determined by clinical assessment and CT scanning.
Agenix is also currently undertaking a Phase II DVT study in the USA and Canada to assess the accuracy of Thromboview against the current contrast venography.
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