Sunday, November 18, 2012

AASLD - BIT225 Hepatitis C Virus 48-week data

Biotron Limited : 16/11/2012 - Presentation of BIT225 Hepatitis C Virus 48-week data at AASLD conference, Boston MA

11/18/2012| 03:13am US/Eastern        
- 100% SVR in patients receiving 400mg BIT225 in combination with standard of care
- No detectable antiviral resistant variants generated during treatment
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Sydney, Australia: 16 November, 2012: Australian drug development company Biotron Limited (ASX:BIT) has presented the latest data from its Phase 2a trial of BIT225 in patients infected with hepatitis C virus (HCV) in a presentation at the American Association for the Study of Liver Diseases (AASLD) 2012 annual conference that took place this week in Boston MA, USA.

The poster entitled "High sustained viral response with a HCV p7 inhibitor, BIT225: Antiviral activity and tolerability of BIT225 plus pegylated interferon alfa 2b and weight-based ribavirin for
28 days in HCV treatment-na├»ve patients" is attached in the Appendix that follows. It was presented in a late-breaking poster session at The Liver Meeting® 2012, the 63rd annual meeting of the AASLD.
The new data shows that 100% of patients who were treated with 400mg BIT225 in combination with the current approved anti-HCV treatment had no detectable virus at the 48-week time point. This compares to 75% of patients who only received the approved treatment, and demonstrates that in this trial BIT225 improved the outcome in patients infected with hard-to-treat genotype 1 HCV infection.
Analysis of blood samples taken from the patients after dosing with BIT225 indicated that the drug did not induce antiviral resistance.
The 48-week data extends the previous three-month data, and demonstrates that BIT225 appeared to continue to provide additional benefit to patients after the conclusion of dosing.
"The data from this trial are very encouraging - to see no detectable virus at the 48 week follow-up is a good outcome for the patients, who are infected with the hard-to-treat genotype 1 version of the virus," reported Michelle Miller, Managing Director of Biotron. "During preclinical development of BIT225, laboratory studies indicated that BIT225 could potentially improve the activity of interferon and ribavirin, and this trial has confirmed that this has translated into benefit for the patients. In addition, the drug does not appear to readily generate resistance, which can be a problem with some of the other new classes of anti-HCV drugs in development."
Biotron's BIT225 targets the HCV viral protein p7, which has crucial roles in virus replication and reproduction. It is a new target, and BIT225 is a first-in-class direct acting antiviral for the treatment of HCV.
BIT225 is also in development for treatment of HIV, with a Phase 1b/2a trial currently in progress. BIT225 offers a unique opportunity for potential use in the HIV/HCV co-infected population. A phase 2 trial in this patient population is current recruiting.   
About Biotron
Biotron Limited is engaged in the research, development, and commercialisation of drugs targeting significant viral diseases with unmet medical need, with a major focus on HIV and HCV. The Company has BIT225 in clinical development for both HIV and HCV, and also has several earlier stage preclinical and research programs for several other viral infections including Dengue.

About BIT225 and HCV
BIT225 represents a first-in-class drug for treatment of HCV, targeting the p7 protein of HCV. It is estimated that in the USA alone, some 4 million people have been infected with Hepatitis C with 2.7 million suffering from chronic infection. Worldwide, 170 million people are infected. HCV causes inflammation of the liver, which may lead to fibrosis and cirrhosis, liver cancer and, ultimately, liver failure. Existing drugs for HCV have limited effectiveness and toxicity issues, leaving a significant need for new therapies. The worldwide market is currently almost US$3.3 billion, but is estimated that this market will expand to over US$10.0 billion as safe, effective therapies enter the market.

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