Australian drug development company Biotron Limited has commenced a landmark phase I b/II a proof-of-concept human trial of its lead HIV drug candidate, BIT225.

Eighteen HIV-positive, treatment-naive patients will be treated with the drug over 10 days. A further eight patients will be given a placebo and both groups will then have a 10 day drug-free follow up.

Biotron scientists have previously established that the oral drug is able to inhibit replication of the HIV virus in monocyte lineage cells, where until now the virus has been able to 'hide' from current drug treatments.

Biotron managing director Dr Michelle Miller said she was confident this trial would further demonstrate the ability of BIT225 to reduce HIV loads in HIV-infected reservoir cells. She described the commencement of the HIV trial as a major milestone for the Company and its lead drug candidate, which has also recorded encouraging data in previous trials in healthy volunteers and Hepatitis C virus-infected patients.

“Treatment and elimination of this virus reservoir remains a major  therapeutic challenge globally,” she added. “BIT225 represents an extremely promising first-in-class opportunity and its progress is being keenly followed by the international pharmaceutical industry and investors.”

Dr Miller said that while current treatments have resulted in reduction of HIV levels in the body, they have not been effective in eliminating virus from underlying reservoirs. “By specifically targeting HIV in reservoir cells, Biotron's BIT225 offers the potential to stop the on-going cycle of infection in the body,” Dr Miller said.

BIT225 is synergistic with commonly used anti-retroviral therapies and, if successful, would potentially be used in conjunction with these treatments. The trial is expected to be completed and results announced in the first quarter of 2012.

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.

BIT225 represents a novel, first-in-class approach to the treatment of HIV.  BIT225 specifically targets HIV in reservoir cells and represents an opportunity to attack HIV at its source in the body. Current HIV therapies have little or no effect on HIV  in the underlying reservoir of infected cells where the virus 'hides' from the immune system. The market for HIV is very large, with the US market alone for HIV worth over US$ 3.3 billion per annum.