Novotech begins cardiovascular trial for Angiogenix

Australian clinical research organisation (CRO) Novotech has begun a cardiovascular drug trial on behalf of US biopharmaceutical company Angiogenix.

The Sydney-based company will be responsible for conducting the trial in Australia and New Zealand, working as part of an international team that also includes research organisations in North America and Europe.

The Phase II trial will study Angiogenix's ACCLAIM (organic nitrate combined with L-arginine) for the treatment of chronic angina. Nitrates are commonly used in cardiac patients but their usefulness is limited by the development of tolerance, which occurs due to the cellular depletion of L-arginine. The study seeks to show that ACCLAIM, by combining L-arginine with a long acting nitrate, can eliminate drug tolerance.

'We have included Australian and New Zealand investigational sites in our study for several reasons,' said Dr William Spickler, vice president of pharmaceutical development at Angiogenix. 'First, the population of patients is similar to those in the US in terms of lifestyle and disease characteristics. In addition, a common language and similar health care systems mean that the patient populations are comparable. This population provides an additional source of patients for inclusion in the study, which will help shorten the time that it takes to complete the trial.

'Finally, the clinical investigators are well trained and are experienced in conducting clinical trials of this type. This capability will help support our efforts in the US and elsewhere around the world.'

Increasingly, US companies are turning to Australia to expedite the pace, and reduce the cost of clinical trials, while maintaining high standard of research. A 2001 Ernst and Young benchmarking study found that clinical research costs may be as much as 20-30% in Australia than in the US and Europe. In addition, Australian regulatory procedures often enable a trial to begin in as little as 2-3 months from the initiation of the approval process. This compares favourably to the usual timeline in major Western countries.