Narhex commences phase I HIV drug trial

Anti-viral drug developer Narhex Life Sciences (ASX:NLS) has commenced recruitment of healthy volunteers for the phase I clinical trial of its anti-HIV protease inhibitor drug DG17.

The purpose of the study is to test an improved formulation of DG17, which Narhex believes will increase the extent and reliability of its absorption.

Another phase of the study will test whether 'boosting' with low doses of the approved HIV drug ritonavir -- marketed by Abbott Laboratories as Norvir -- will allow lower doses of DG17 and/or an increased dosing interval. Both studies are open label without a placebo.

"Our interpretation of the existing data is that the drug absorption is variable from person to person," explained Narhex managing director Prof John Mills. "We are very confident that the principal problem is the formulation. Based on our findings we will either reformulate or continue the next phase of trials with this formulation. This is the first and there may be subsequent reformulations -- it is just the nature of working with protease inhibitors, but we are confident we can do this fairly rapidly."

According to Mills, recruitment for the first phase of the study should only take a few weeks and the entire study should be completed and the data analysed and available by the end of March.

The study was approved following review by the research and human ethics committees of the Alfred Hospital, and has been successfully registered with the Therapeutic Goods Administration. The study itself is being conducted by the Centre for Clinical Trials, a division of the Nucleus Network.

Principal investigator for the study is pharmacologist Prof Henry Krum, supported by Dr Kate Cherry and Prof Sharon Lewin, an HIV clinician who is chief of infectious diseases at the Alfred Hospital in Melbourne.

Study subjects are hospitalised for a day and given doses of DG17 under direct observation. Blood samples are taken at intervals to analyse the concentration of DG35, the active principle of DG17 in blood. Monitoring for any adverse effects is also being undertaken.