Agenix on track for hepatitis B drug trial

Agenix (ASX:AGX) is on schedule to commence its planned phase I trial of AGX-1009 as a hepatitis B treatment in China.

In a presentation at the debut AusBiotech Brokers Meet Biotech investment event in Melbourne on Thursday, Agenix CEO Nick Weston said the company was on track to submit a formal clinical trial application in Q3 2012.

Melbourne-based Agenix will jointly submit the application with its strategic partner in China, the Institute of Medicinal Biotechnology at the Chinese Academy of Medical Sciences.

Subject to approval of the application by China's State Food & Drug Administration, the trials would then be able to commence in 2013.

AGX-1009 is a nucleotide analogue reverse-transcriptase inhibitor (NtARTI), which shares an active compound – tenefovir – with Gilead's Viread product.

Viread has been approved in the US and Europe as a treatment for hepatitis B (HBV) and HIV, but has not been cleared for the Chinese market.

Weston cited estimates that around 120 million people in China are infected with HBV today, including 10 million currently being treated with drugs.

The hepatitis B virus eventually adapts to traditional treatments including lamivudine, adefovir and telbivudine, requiring patients to switch to an NtARTI drug.

IMS Health has estimated that the market for HBV treatments in China was worth $460 million in 2009, and will nearly triple to $1.3 billion in 2019.

Agenix is also currently involved in partnership and licensing discussions with potential allies for a phase III trial of ThromboView, its blood clot diagnostic technology.

Weston said two prior successful phase II trials have generated strong interest in the product.

ThromboView uses single photon emission tomography (SPECT) to detect blood clots. Unlike in the current standard treatment, computed tomography pulmonary angiography, patients undergoing ThromboView scans are receive a significantly lower dosage of radiation than used in PET CT scans.

Agenix (ASX: AGX) shares fell 7% in Thursday's trading to $0.013.