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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 not required to be dosed with radiation.

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

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Avatar universal
interesting that viread is not on Chinese market but they agree on a trial using the same chemical substance like viread
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Avatar universal
Both drugs contain Tenofovir but have different molecular side chains to activate that compound. Both drugs work by blocking an enzyme the hepatitis virus needs to replicate.

AGX-1009 is one of several new drug candidates supported by the Chinese Government’s State Special Funds for important new drugs, which aims to expedite new mass market therapies for major diseases in China. Gilead's version is expected to be released on the Chinese market in 2014.


I understand that VIREAD will enter the Chinese market, and how about AGX-1009, how this will be manage ? why the AGX-1009 and VIREAD are different ?
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Avatar universal

hopefully the cures of hbv like trl7 agonists, rep9ac and myracludex will kill these useless drugs, i dont think there is any need of other nucs on the market but just cheap unpatented tenofovir
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Avatar universal
"why the AGX-1009 and VIREAD are different ? "

Viread (full name: tenofovir disoproxil fumarate) is a prodrug of tenofovir.  The 'disoproxil' is a side chain attached to the active component 'tenofovir'.  Inside our body, this side chain gets cleaved off by an enzyme to release the active tenofovir.  AGX-1009 has a different side chain attached to the active component 'tenofovir'.  It may show higher potency and/or lower toxicity compared to Viread because of this different side chain (At least that's what Agenix is hoping for).

Gilead's GS-7340 is another prodrug of tenofovir with yet a different side chain.  It's now in phase II clinical trial on HIV.  Here's Gilead's claim: "In previous studies, GS-7340 has demonstrated the ability to provide greater antiviral efficacy at a dose that is ten times lower than Viread."


My guess is:  since Viread's patent will expire in 2-3 years, Gilead is trying to come up with a new drug (Well, sort of 'new').  And Agenix is competing with them.

P.S.  I had some training in medicinal chemistry.
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Avatar universal

it is so increadible how politicians/medical institutions are so corrupted to allow patents to same active ingredients for just such a small change....the all medical system is disgusting if they will allow this ridiculous fraud
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