Minister for Health, Lawrence Springborg MP Minister for Agriculture, Fisheries and Forestry, Dr John McVeigh MP Minister for Primary Industries and Small Business, Katrina Hodgkinson MP
Thursday 31 October 2013
World-first Hendra treatment one step closer Queensland researchers are about to take a major step closer towards proving the safety of the only known effective treatment for preventing human disease with Hendra virus once a person has been exposed. Queensland Health Minister, Lawrence Springborg, New South Wales Minister for Primary Industries, Katrina Hodgkinson, and Queensland Minister for Agriculture, Fisheries and Forestry, Dr John McVeigh, today announced a $1.2 million grant to fund a clinical trial of a human monoclonal antibody capable of neutralising Hendra virus. “This world-first trial will test the monoclonal antibody in a small group of people for the first time to evaluate its safety, determine a safe dosage range and identify any side effects,” Mr Springborg said. “There are many organisations involved in Hendra virus research and treatment as it’s a problem that knows no borders. “This is a collaboration between groups in Queensland, NSW and the United States to develop a new medicine that could save lives in the event of a Hendra virus incident in Australia.” “Funding for the trial was drawn from $9 million provided for Hendra virus research from the Queensland, NSW and Commonwealth governments National Hendra Virus Research Program, which all contributed $3 million each for Hendra virus research. “The Commonwealth Government also provided a separate $400,000 National Health and Medical Research Council grant to the University of Queensland,” Mr Springborg said. Ms Hodgkinson said this research was a significant step forward in combating a deadly virus. “This work is globally significant and, along with advancements in horse vaccine development, is critical in our future control strategies,” Ms Hodgkinson said. “The NSW Government is pleased to be able to team up with our Queensland and Commonwealth counterparts to help develop scientific solutions to tackle Hendra virus, which has caused so much concern to our communities over many years.
Minister for Health, Lawrence Springborg MP Minister for Agriculture, Fisheries and Forestry, Dr John McVeigh MP Minister for Primary Industries and Small Business, Katrina Hodgkinson MP
“This project, combined with others funded through the Hendra Virus Taskforce, brings together leading researchers from NSW, Queensland, Victoria and the USA to tackle this deadly virus.” The antibody for the trial was developed through a long-standing association between Queensland Health and the laboratories of Professor Christopher Broder of the Uniformed Services University of the Health Sciences and Dr Dimiter Dimitrov of the National Cancer Institute, National Institute of Health in the United States. They also worked with researchers at the Australian Institute for Bioengineering and Nanotechnology (AIBN) at the University of Queensland, and clinicians at Princess Alexandra Hospital in Brisbane. AIBN Director Professor Peter Gray said the monoclonal antibody to be used in the trial – known as m102.4 – was classified as a biologic medicine and was manufactured at the AIBN’s National Biologics Facility using specialised cell factories developed by US collaborators, and a production process developed at AIBN. “Biologics are medicines based on natural proteins made using recombinant DNA technology with the potential to target medical conditions for which there are no other treatments,” Professor Gray said. “It is important to understand that monoclonal antibody therapy is not a vaccine for the general population, but a treatment which is expected to improve a person’s chance of survival should they have come into contact with the Hendra virus. “The Phase I clinical trial is planned for early 2014 upon approval from a Human Research Ethics Committee and in compliance with National Health and Medical Research Council guidelines. “The United States is also interested in the results of the clinical trial as Hendra virus is similar to the Nipah virus which can cause death and severe illness in people and animals. Nipah virus is regularly found in humans in Bangladesh and India,” he said.
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Minister for Health, Lawrence Springborg MP Minister for Agriculture, Fisheries and Forestry, Dr John McVeigh MP Minister for Primary Industries and Small Business, Katrina Hodgkinson MP
Background Hendra virus is a rare zoonotic disease. Since 1994, there have been 48 incidents of Hendra virus in horses in Australia including 13 in NSW and 35 in Queensland. Eighty five horses have died from the Hendra virus during this period. There have been seven human cases, all in Queensland. Four of those cases were fatal. The broad collaboration involves: the Queensland and NSW Governments; the Commonwealth Department of Health; AIBN, UQ; the Australian Animal Health Laboratory; Q-Pharm; and in the U.S., the Uniformed Services University of the Health Sciences and The Henry M. Jackson Foundation for the Advancement of Military Medicine Inc, which coordinated the agreements for the transfer of the m102.4 monoclonal antibody to Queensland for compassionate use. The monoclonal antibody has been administered to four Brisbane people who had high-level exposure to the Hendra virus. At present, the monoclonal antibody is considered an experimental medicine and can only be used in emergency situations for compassionate use with approval from an ethics committee and representatives from the Therapeutic Goods Administration. AIBN researchers have produced batches of a monoclonal antibody, which may offer hope as a potential therapeutic for Hendra virus infection in humans. US Hendra virus expert Professor Chris Broder developed the antibody, which binds to a protein on the surface of virus particles, blocking entry to healthy human cells. It is hoped that this will then allow the immune system to fight off the virus. Hendra virus can be passed from bats to horses and in rare cases from horses to humans. Dr Alister Rodgers became the first person to receive the antibody treatment in a desperate bid to save his life. He was working as a vet in Rockhampton when he came into contact with an infected horse and died in 2009.
Minister for Health, Lawrence Springborg MP Minister for Agriculture, Fisheries and Forestry, Dr John McVeigh MP Minister for Primary Industries and Small Business, Katrina Hodgkinson MP
The antibody was also given in 2010 to two people from the Sunshine Coast exposed to the Hendra virus. Queensland Health sourced these antibody stocks from the US. It became clear a Queensland solution was needed to supply larger amounts of the antibody in case of future Hendra outbreaks. In late 2010, Queensland Health provided $300,000 to AIBN to produce batches of the antibody for humans. Last month AIBN received $180,000 in additional funding from Queensland Health to continue producing the antibody, adding to $40,000 received from the Alister Rodgers Memorial Fund early in 2011. The Alister Rodgers Memorial Fund honours the life of Dr Rodgers and was established through The University of Queensland’s School of Veterinary Science at the request of his family, to raise money for research into Hendra virus. It is considered an experimental therapy because large-scale clinical testing has not been completed on the antibody. It can only be used in emergency situations with approval from an ethics committee and representatives from the Therapeutic Goods Administration. To date the AIBN has produced enough of the experimental antibody to treat up to 20 people, with further material to be produced later this year. In addition, AIBN has produced the antibody for collaborators at the CSIRO Australian Animal Health Laboratory in Geelong for testing in animal trials. Other CSIRO research developed a vaccine for horses designed to prevent Hendra infection. AIBN biotechnologist and antibody project overseer Associate Professor Stephen Mahler said the institute had specialist equipment able to make highquality batches of the antibody for humans. Dr Mahler said the antibodies were originally created under the leadership of Professor Broder at the Uniformed Services University, Bethesda, Maryland in the US as part of a long-standing collaboration with the CSIRO. The US lab was able to synthetically produce a portion of the virus and create an antibody that specifically recognised it. Antibodies can be produced using recombinant DNA technology, where the gene encoding the antibody is transferred to a cell that is able to express large amounts of the protein. The US lab provided the cells that were producing the antibody and the AIBN developed a process to produce larger amounts of the antibody. AIBN did not produce any part of the Hendra virus.
Minister for Health, Lawrence Springborg MP Minister for Agriculture, Fisheries and Forestry, Dr John McVeigh MP Minister for Primary Industries and Small Business, Katrina Hodgkinson MP
For Hendra virus information, visit www.dpi.qld.gov.au/4790_2900.htm. *taken from http://www.aibn.uq.edu.au/hendra-virus-facts
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Minister for Health, Lawrence Springborg MP Minister for Agriculture, Fisheries and Forestry, Dr John McVeigh MP Minister for Primary Industries and Small Business, Katrina Hodgkinson MP
Frequently asked questions What is an antibody? An antibody is a blood protein produced in response to – and counteracting – a specific antigen. What diseases are antibody therapeutics used for? Antibody therapeutics, also known as biologics, are now widely used for autoimmune diseases such as cancer, arthritis and psoriasis. What does the Hendra virus antibody do? The antibody binds to protein on the surface of Hendra virus particles, blocking entry to healthy human cells. The immune system is then able to fight off the virus. How many people have been given the antibody treatment so far? Four. Three of these people were given an antibody treatment produced at the Walter Reed Army Medical Center in Washington DC. The fourth person was given an antibody produced at the AIBN at the University of Queensland. Why is the antibody considered an experimental therapy? The antibody has not been through human clinical trials. Phase two and three Clinical trials take years and involve large numbers of people. The small number of people exposed to the Hendra virus make clinical trials difficult at this stage. Who makes the decision about giving people the antibody? Decisions on administration of the antibody are handled by Queensland Health, specifically the Chief Health Officer and infectious disease experts at the Princess Alexandra Hospital. Any human treatment requires a special approval from an ethics committee and the Therapeutic Goods Administration. How much of the antibody is available for humans? A batch of more than 20g has been given to Queensland Health – enough to treat up to 20 people. How can the Hendra virus kill? People develop a flu-like illness, including fevers and respiratory symptoms. The virus causes inflammation in the cells that form in the lining of the body’s small blood vessels, particularly those in the brain and the lungs. The virus predominantly infects the cells which form the inside layer of blood vessels. Infection can cause small blood vessels, which supply oxygen to the body, to become obstructed.
Minister for Health, Lawrence Springborg MP Minister for Agriculture, Fisheries and Forestry, Dr John McVeigh MP Minister for Primary Industries and Small Business, Katrina Hodgkinson MP
Collaboration Partners University of Queensland’s AIBN The University of Queensland's Australian Institute for Bioengineering and Nanotechnology (AIBN) is an integrated multi-disciplinary research institute bringing together the skills of world-class researchers in the areas of bioengineering and nanotechnology. It is home to 19 research groups working at the interface of the biological, chemical and physical science to alleviate current problems in human health and environmental issues. The Institute has three key areas that collectively distinguish it from other institutes in the country, namely AIBN's: Research excellence Industry focus, and Dynamic research environment. These characteristics focus AIBN research efforts on developing new products, processes and devices for improving human health and quality of life. In this way the Institute goes beyond basic research to promote and develop the growth of innovative industries, which will benefit the Queensland and Australian economies. Q-Pharm Q-Pharm specialises in the conduct of early phase (Phases one and two) clinical trials, bioequivalence and bioavailability studies and vaccine studies. These studies are conducted in a state-of-the-art facility within the QIMR Berghofer precinct at the Royal Brisbane and Women’s Hospital, Brisbane, Australia. They provide a comprehensive, high quality service to our clients, and conduct clinical trials in accordance with all applicable national and international standards and guidelines. Q-Pharm’s strength is its highly-qualified clinical trial team, whose leaders have a wealth of experience in clinical development. This experience enables Q-Pharm to understand the needs of our diverse range of clients and thereby deliver on time the highest quality clinical services to satisfy client needs.
Minister for Health, Lawrence Springborg MP Minister for Agriculture, Fisheries and Forestry, Dr John McVeigh MP Minister for Primary Industries and Small Business, Katrina Hodgkinson MP
Q-Pharm has more than 11 years of experience in healthy volunteer and patient studies from first time in human through to Phase three and the founders had over 20 years of prior experience. We have conducted studies using biological agents, vaccines and pharmaceutical agents using a range of delivery modalities including oral, intra-venous, sub-cutaneous, implant, inhalation and trans-dermal routes of administration. Australian Animal Health Laboratory CSIRO's Australian Animal Health Laboratory (AAHL) provides world-class capability in bio-containment research, with a special focus on serious emerging zoonotic diseases such as Hendra virus. AAHL has already played a critical role in the evaluation of the efficacy of the Hendra mAb in prevention of disease following exposure to Hendra virus, and it will provide a safe and secure environment for critical aspects of ongoing evaluation of the antibody during this phase of safety testing in the human population.
