Biotron Limited · ASX:BIT
Biotron — Shareholder Meeting (October 2009)
14 slides from Biotron's shareholder meeting presentation, Oct 16, 2009
Slide 1: AGM 16 October 2009
Biotrormn AGM 16 October 2009
Slide 2: Key Highlights for 2008/2009
Key Highlights for 2008/2009 • Successful completion of Phase I/IIa clinical trial (BIT225-003) of BIT225 in Hep C+ subjects • Successful rights issue, raising $0.8 million in March 09 1
Slide 3: BIT225-003: Proof-of-Concept Trial
BIT225-003: Proof-of-Concept Trial A Phase Ib/IIa, Placebo-Controlled, Randomised Study of the Safety, Pharmacokinetics and Antiviral Activity of BIT225 in Patients (Males and Females) with Hepatitis C Virus Infection. Objectives: 1. To assess the safety and tolerability of 35 and 200 mg of BIT225 t
Slide 4: BIT225-003 Shows Proof-of-Concept
BIT225-003 Shows Proof-of-Concept • BIT225 was well tolerated with no serious adverse events reported and no discontinuations from the study. • BIT225 reached good levels in the blood, that are within the potential therapeutic range and are consistent with the potential for once or twice-daily oral
Slide 5: Trial Reflects HCV Types in the Community
Trial Reflects HCV Types in the Community Genotype Frequency of Specific Genotypes BIT225-003 Trial Australia 1a/b 56% 50% 2 6% 7% 3a 38% 35% Not all HCV genotypes respond equally to current treatment; Genotype 1 is particularly resistant to interferon and ribavirin 4
Slide 6: BIT225 – Potential New Treatment for HCV
BIT225 – Potential New Treatment for HCV Preclinical studies indicated: Activity against hard-to-treat genotype 1 Synergistic with current standard-of-care (IFN/ribavirin) Clinical trials have shown: Good PK (half-life, bioavailability, etc) and safety profile in studies to date Statisti
Slide 7: Further Development of BIT225
Further Development of BIT225 • Focused on developing products we can sell to a pharma partner – Aim is to maximise value to shareholders • Future HCV therapies expected to be a cocktail of antiviral drugs – Industry focus on developing new, specific antiviral drugs to use in combination – P7-inhibi
Slide 8: Further Development of BIT225 (cont)
Further Development of BIT225 (cont) • BIT225-003 – extend to do 400 mg dose – Protocol amendment to existing trial – One more cohort (6 subjects) – Timeframe – submit amendment in Oct; Approvals early Nov; Conclude early Q1 2010 – Aim to show higher dose further improves activity of BIT225 • BIT225
Slide 9: Beyond HCV - Pipeline of Antiviral Drug Programs
Beyond HCV - Pipeline of Antiviral Drug Programs • Developing new generation antiviral drugs with large, expanding world markets. • Current major focus on developing new drugs to treat Hepatitis C virus (HCV) and HIV; pipeline of earlier stage projects Project Target Discovery Preclinical Phase I Ph
Slide 10: SUMMARY
SUMMARY • Biotron has a strong competitive position in a high profile therapeutic area • New mode of action drug for HCV • Proven activity in Phase Ib/IIa clinical trial • Strong patent position (applications for drug itself as well as usage) • New mode of action drug for HIV - Ib/IIa trial ready to
Slide 11: Dr Michelle Miller, Chief Executive Officer
Dr Michelle Miller Chief Executive Officer +61 2 9805 0488 mmiller@biotron.com.au www.biotron.com.au
Slide 12: Commentary for a Presentation to the 2009 Annual General Meeting
COMMENTARY FOR A PRESENTATION TO THE 2009 ANNUAL GENERAL MEETING 16 OCTOBER 2009 I am pleased to be able to present this update on the Company’s activities. Slide 1 The last 12 months have seen significant advances on clinical progression of Biotron Limited's ('Biotron' or the 'Company') antiviral d
Slide 13: Commentary: trial results and analysis
Results from the trial were only available after the end of the study, at which time they were unblinded and analysed. It was important to take the necessary time to perform a complete analysis of all the data. This is not something that can be rushed and the fact that Biotron completed its analysis
Slide 14: Commentary: further trials and pipeline
most easily be done by extending the recently completed trial to include another group of patients to receive a higher dose of drug. We also know from preclinical cell culture assays that the potency of BIT225 appears to be significantly increased in combination with the current drugs used to treat