Agenix locates DVT clot in clinical trials

Thrombosis diagnostic specialist Agenix has successfully detected a deep vein thrombosis (DVT) clot in the leg of a patient during Phase Ib clinical trials.

Agenix’ platform, ThromboView, uses a clot-binding monoclonal antibody attached to a radiolabel. Following injection of the compound into a patient with a suspected blood clot, the antibody is carried by the bloodstream, and binds to any blood clots.

The resulting radiolabelled "hotspots" can be picked up by a suitable imaging camera, and used to locate and diagnose the presence of the blood clot.

The trial, being conducted at Royal Brisbane Hospital, has produced what was described as “a very pleasing result.” The next step for Agenix will be to file further trial application with the US FDA, said Don Home, Agenix managing director.

"This is a big moment for our company, and we anticipate filing an Investigational New Drug application with the US Food & Drug Administration and initiation of Phase II clinical trials in North America in early 2004," he asserted.

Dr David Macfarlane, co-investigator of the trial said the trial also indicated no tolerance problems. "Previously, ThromboView has been injected into healthy volunteers," he said. "It was not only well tolerated in the patient with the DVT, but it detected the presence of the DVT in the patient's leg," he said.

The trial is anticipated to expand to other hospitals, and test the compound on patients with confirmed DVT at Westmead and St George Hospitals in Sydney, and at Melbourne's Austin Repatriation Hospital. "It is estimated that up to 10,000 people die of undetected blood clots each year in Australia. There are approximately 33,000 cases of DVT each year in Australia and 4,200 cases of pulmonary embolism (clots in the lungs),” said Home.

"Today's trial commencement is a major step in the development of a breakthrough test,” he added.