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Additional Information

Market:	ASX
Sector:	Pharma & Biotech
EPIC:	AGX
Latest Price:	0.01 (0.00%)
52-week High:	0.02
52-week Low:	0.01
Market Cap:	4.60M

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Agenix

Agenix Limited was listed on the Australian Stock Exchange in October 1987. Today's two primary businesses consist of AGEN Biomedical (headquartered in Brisbane, Australia) and Agenix Bio-Pharma Shanghai, in The People's Republic of China.

Agenix remains on course to apply for Hepatitis B drug clinical trials in China

Wednesday, June 08, 2011

Agenix (ASX: AGX) has confirmed the company remains on track to submit a formal application to begin clinical trials in China for its lead Hepatitis B drug, AGX 1009.

The company plans to file a formal application with China’s State Food and Drug Administration in the second quarter of 2012, and anticipates approval to begin Phase I human studies in late 2012.

Agenix, a China–focussed drug development and diagnostic company, confirmed the drugs status following a series of meetings in Australia with senior representatives of Agenix’s joint venture partner, the Beijing–based Institute of Medicinal Biotechnology (IMB) of the Chinese Academy of Medical Sciences.

The patents for AGX–1009 run until 2026 and the company plans to make the drug available as a once–daily treatment.

AGX–1009 belongs to a new class of drugs that work by blocking an enzyme the hepatitis virus requires to replicate.

AGX–1009 is a so called a ‘prodrug’ in the same class as Tenofovir, marketed by GlaxoSmithKline (NYSE: GSK, LON: GSK) in Asia as Viread® and which gained approval in the US in 2008.

Viread®, or tenofovir disoproxil fumarate, is a prescription medicine used to treat chronic Hepatitis B virus in adults.

The drug has already passed a number of early development hurdles and has been found to have a low toxicity profile, as well as not inhibiting the group of enzymes that process drugs in the liver.

The meetings in Australia with senior representatives of China’s IMB, led by Professor Jiang Jian–Dong, focussed on key pharmacology, toxicology, chemical composition, manufacturing methods and clinical trial protocol data submissions for AGX–1009

Nicholas Weston, chief executive officer of Agenix, said “together we believe [with IMB] we have the opportunity to significantly improve the health and quality of life for millions of people by commercialising promising new drug candidates quickly and at a fraction of the cost it would take in the US or Europe.”

The drug has received support by the Chinese Government’s State Special Funds for important newly developed drugs.

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