New radiopharmaceuticals approved for human clinical trials

The Australian Nuclear Science and Technology Organisation (ANSTO) has been licensed by the Therapeutic Goods Administration to manufacture radiopharmaceuticals that include fluorine-18 (F-18) for further clinical trials.

This means that medical manufacturers can rely on the ANSTO to supply them with radiopharmacetuicals.“This development builds on ANSTO’s broader strengths in the commercial production of radioisotopes and radiopharmaceuticals,” said Dr John Bennett, leader, biosciences at ANSTO’s National Research Cyclotron Facility.

Moving to this phase of clinical trials means that testing can occur on several hundred to several thousand people and are the final phase before routine clinical use approval.

F-18 is the most widely used radioisotope in clinical imaging and can find the location and stage of diseased tissue, show the effectiveness of treatment, and help medical professionals understand the physiological and metabolic processes involved in diseases.

The radiopharmaceuticals manufactured at the National Research Cyclotron, located in the inner Sydney suburb of Camperdown, had to undergo a stringent approval process, which will guarantee safe, sterile, effective and high-quality pharmaceuticals, while also providing reams of supporting documentation. The facility is run in partnership with the University of Sydney.

The cyclotron produces a beam of charged particles that are accelerated in a spiral path. Besides producing radioisotopes for pre-clinical and clinical trials, the National Research Cyclotron Facility contributes to the production of radiotracers for research purposes.

Previously, the ANSTO has used F-18 to develop low-cost PET scans. In hospitals, these scans can diagnose cancer and brain disorders such as cancer and Alzheimer’s disease. The use and development of these scans is an essential component of treatment, and according to the ANSTO one in two Australians will undergo a nuclear medicine procedure that uses a radioisotope, similar to the isotopes that ANSTO has current been approved to produce. In recent research, the ANSTO has attached F-18 to amino acids to speed up reactions that could take months.