A new treatment developed by Walter and Eliza Hall Institute
researchers to promote the cure of chronic hepatitis B virus (HBV)
infection is now recruiting patients for a phase I/2a clinical trial.
Dr Marc Pellegrini, Dr Greg Ebert and colleagues developed the new treatment in collaboration with TetraLogic Pharmaceuticals,
a biotech company based in Malvern, Pennsylvania, US. The clinical
trial will be held at sites across Australia and New Zealand, with
planned sites in Melbourne, Adelaide, Perth and Auckland.
Hepatitis B is a viral disease that infects liver cells. Although a
vaccine has been available since 1982, more than two billion people
worldwide are infected with the virus. Most patients will recover from
the disease, but 5-10 per cent of patients will develop a chronic
infection, with children most at risk. More than 780,000 people die
every year from complications associated with chronic hepatitis B
infection, including cirrhosis and liver cancer.
The new treatment uses TetraLogic Pharmaceutical’s drug birinapant,
which triggers the breakdown of proteins that prevent infected cells
from self-destructing. Dr Pellegrini said these proteins, known as
‘inhibitors of apoptosis proteins’ (IAPs), can be targeted to allow
infected cells to die.
“Our preclinical models have shown that birinapant kills infected
liver cells, while not harming uninfected cells,” he said. “Used in
conjunction with an existing treatment for hepatitis B, this drug has
the potential, for the first time, to functionally cure chronic
hepatitis B infections.”
Dr Pellegrini said the new treatment had the potential to
revolutionise the way chronic HBV infections were treated. “Patients who
develop chronic infections can be treated with drugs that prevent the
virus from replicating, reducing the amount of virus in the liver, but
do not completely eliminate the virus,” he said. “These patients are
dependent on anti-viral drugs that need to be taken for a very long
period of time to reduce the risk of virus-induced liver damage and the
complications that come with it.
“Our new therapy combines an existing anti-viral drug, which reduces
the viral load, with birinapant that promotes efficient killing of
hepatitis B infected cells and clearance of the virus from the system.”
“We are really excited that this treatment has entered phase 1/2a
clinical trials as it is a culmination of many years work in developing
new strategies to tackle chronic infections.”
Based on his crucial research, Dr Pellegrini is the key scientific
and clinical advisor for the clinical study that is now underway. The
study is sponsored by TetraLogic Pharmaceuticals Corporation in
collaboration with Nucleus Network in Melbourne and hospitals across
Australia and New Zealand.
The phase 1/2a clinical trial will involve approximately 50 patients
and is currently recruiting eligible participants. For more information
about the trial and eligibility, contact Nucleus Network on 1800 243 733
or contactus@centreforclinicalstudies.com.au.
Download the media release (PDF).
Further information:
Alan Gill
Science Communications Officer
P: +61 3 9345 2719
M: +61 419 591 102
E: gill.a@wehi.edu.au
Press Release Source: http://www.wehi.edu.au/site/latest_news/potential_cure_for_hepatitis_b_enters_phase_1_2a_clinical_trial
Labels: birinapant, clinical trials, Cure, TetraLogic