Agenix antibody manufacture trial successful

Brisbane-based company Agenix has successfully manufactured 1.4g of its clot-binding humanised antibody under good laboratory practice (GLP) conditions in preparation for pre-clinical testing of its Thromboview blood clot imaging system, the company said.

The antibody was manufactured under a collaborative effort involving scientists from Agenix, CSIRO Health Sciences and Nutrition, and Progen Industries.

Agenix now plans to manufacture a similar amount of product for use in clinical trials under current good manufacturing practice (cGMP) conditions. cGMP is the standard required for all pharmaceutical products.

"We'll have it produced, tested and in vials by the end of July," said CEO Don Home. "It is a significant milestone. To manufacture under quality controlled conditions is very important. You have to be able to show that it works every time."

The Thromboview blood clot imaging technology is based on an antibody against the D-Dimer, a protein released into the circulation during the fibrin blood clot breakdown process.

In the Thromboview system, a fragment of the antibody is labelled with radioactive technetium, and then injected into patients. Blood clots will bind the antibodies and the excess is safely removed from the body via the kidneys. A special imaging system is then used to localise the radioactively labelled clots.

The antibody fragment has been humanised to minimise the development of immunity against the fragment.

Agenix plans to test the Thromboview system on patients with deep vein thrombosis (DVT) in clinical trials scheduled to start in November.

"In Phase I, we'll have two groups of patients," Home said.

"One will be healthy volunteers to make sure there are no adverse effects. The second group will be a cohort of patients with DVT."

Home explained that the second group of patients was very exciting for the company as treating affected patients would not normally happen until Phase II trials.

"The results from the DVT arm of the Phase I trial will provide us with a good indication of the likely outcome of our Phase II and III trials," he said, explaining that if the Phase I trial was successful, the company would seek to accelerate further trials.

Agenix is funding the development of Thromboview via profits from its subsidiaries Agen Biomedical and Milton Pharmaceuticals.