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Biotron Limited (BIT:AU) BIT225 Reverses HIV-Induced Impairment Of The Immune System

7/23/2014 8:29:07 AM

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• BIT225 treatment results in normalisation of the immune activation marker sCD163
• BIT225 reduces HIV levels in reservoir-seeding cells
• Potential to prevent reseeding of HIV infection in T cells of patients on current antiretroviral treatment (ART)

Biotron Limited (ASX: BIT) has presented new data from its trial of BIT225 in HIV-infected subjects at AIDS 2014, the 20th International AIDS Conference, underway in Melbourne, Australia this week.

The latest findings have shown that BIT225 is able to reverse HIV-induced impairment of the immune system.

HIV infection causes immune activation and inflammation, which are associated with adverse outcomes in patients, including accelerated aging and neurological dysfunction. Immune activation is detected by elevated levels of specific markers in the blood.

Blood samples taken from HIV-infected patients treated for 10 days with BIT225 showed a significant reduction in levels of the inflammatory marker sCD163. sCD163 is a marker of immune activation associated with cells known as macrophages. At the end of treatment, sCD163 returned to pre-treatment levels. This was in contrast to samples from placebo-treated controls in which levels of sCD163 remained unchanged throughout the study.

Previously released data from this trial (BIT225-004) showed that BIT225 successfully reduces virus levels in reservoir precursor cells known as monocytes. These cells turn into macrophages in tissues, where they act as long-term reservoirs of virus that is not cleared by current antiretroviral drugs. The presence of these pools of virus, which are below the limit of detection of standard assays, puts continual pressure on the immune system, resulting in ongoing immune activation.

Dr John Wilkinson, Biotron's Senior Virologist, commented - "The aim of drug treatment for HIV is to not only reduce virus levels, but also to dampen down the associated immune activation. BIT225 can potentially target both sides of the problem, resulting in reduction of virus and a normal functioning immune system."

Targeting virus within monocyte/macrophage cells is central to prevent the ongoing cycle of infection and re-infection of T cells with HIV in infected patients. This trial is the first demonstration of the feasibility of such an approach.

The BIT225 trial was conducted on 21 patients at an international clinical trial unit in Bangkok, Thailand. Patients enrolled in the study were HIV-infected, with high levels of virus and good CD4+ T cell counts. None had previously received treatment with anti-retroviral drugs. Patients received either BIT225 (400 mg; twice daily) or placebo for a period of 10 days.


Dr Michelle Miller
Managing Director
Biotron Limited
Rudi Michelson
Monsoon Communications
+61-3 9620 3333

About Biotron and BIT225
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 Hepatitis C virus (HCV). The Company has BIT225 in clinical development for both HIV and HCV, and also has earlier stage preclinical and research programs for other viral infections including Dengue.

BIT225 has recorded encouraging data against HCV in clinical trials. A phase 2a trial in HCV demonstrated that 100% of HCV genotype 1 infected patients receiving BIT225 (400 mg) in combination with current standard of care therapies interferon and ribavirin had undetectable virus after 48 weeks.

A phase 2 trial in HIV/HCV co-infected patients showed that all HCV genotype 3 patients completing 28 days of treatment with BIT225 in combination with interferon and ribavirin were clear of virus at the 3 and 6 month time points of the trial.

BIT225 is also in development for treatment of HIV, and is the first in a new class of antiviral drugs that may provide a new approach to eradication of this virus. It has shown clinical efficacy against HIV in reservoir cells, and has the potential to be combined with new or existing anti-retroviral drugs to eradicate long-lived pools of virus that are not eliminated with current treatments and prevent reseeding of infection in T cells of patients.

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