LANDMARK HIV TRIAL UNDERWAY
Unique approach to eliminate viral reservoir
First-in-class therapy
Sydney, Australia: 29 September 2011: Australian drug development company Biotron
Limited (ASX:BIT) has commenced a landmark phase 1b/2a 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.
2
"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.
Good results will put BIT in a league of its own and will be re-rated accordingly.
BIT - making the incurable curable.
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