Agenix to move toward ThromboView registration trials

By Elaine Rigoli

Tampa, Fla., June 20 - Agenix Ltd. said the results of the repeat interim analysis from the phase 2 deep vein thrombosis (DVT) clinical trial support the advance of the program toward registration trials.

Results obtained when assessed against the Food and Drug Administration reference standard, venography as read by a central venography adjudication committee, included:

• ThromboView achieved an overall accuracy of 77% compared with 77% for compression ultrasound read at the local trial sites and 87% for venography read at the local trial sites;

• Optimal ThromboView sensitivity was 76% in all patients with DVT based on images taken three hours after injection;

• ThromboView detected clots in 94% of patients with DVT above the calf (proximal clots) based on images taken three hours after injection;

• For patients pre-determined by venography as DVT negative, ThromboView confirmed the absence of clots in 94% of patients (using a three hour and 15 minute paired set of images).

Compression ultrasound is the procedure most commonly used in clinical practice, the company said in a news release.

Venography is far less used in clinical practice because it is an uncomfortable and invasive procedure, the release said.

"Clinical trial results in phase 1 and 2 studies with ThromboView support a move to seek FDA consultation on design and approval of pivotal registration trials," said Paul Eisenberg, scientific advisory board ThromboView sub-committee chairman, in a statement.

Agenix is a biotechnology company based in Brisbane, Australia.

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