Apr. 2, 1998 The Australian influenza drug, GG167, today begins a regulatory and commercial phase which could see the drug, now called Relenza TM, available to the public by next winter. The obstacle course of scientific and clinical development was completed today with application by Biota Holdings Limited for regulatory approval for Relenza's clinical use.
CSIRO's Dr Tom Spurling, who now heads the laboratory where the drug development program was initiated, praised the scientists involved in the research and Biota, the Australian pharmaceutical company who championed it.
"This is the culmination of 20 years of Australian research and development," said Dr Spurling. "The team, led by Dr Peter Colman, and collaborating with Professor Mark von Itzstein's group at the Victorian College of Pharmacy, received commercial backing from Biota. In 1989, Biota formed a partnership with Glaxo Australia Pty Ltd to develop and market the research internationally. The result has been the world's first anti-viral drug for the treatment of all strains of 'flu."
"Influenza has always been a problem because of its rapid rate of mutation, resulting in the continuous development of new strains like the virulent strain which hit Hong Kong recently," explained Dr Spurling. "This makes the development of new vaccines difficult and keeps 'flu one step ahead. What Peter Colman and his colleagues did was to determine the structure of part of the virus and identify a small pocket on the surface which is constant in all strains. This pocket became the target for a designer drug molecule which plugs the pocket, preventing the virus from replicating."
Dr Spurling said that initially there had been a degree of scepticism about CSIRO's approach. "It is a tribute to the tenacity of Peter Colman and his colleague Dr Jose Varghese that the drug has reached this stage," he said.
Dr Colman, along with Professor von Itzstein and Dr Graeme Laver, who was involved in the early stages of the research, shared the 1996 Australia Prize for their contributions to this project.
Colman, who now heads Melbourne's Biomolecular Research Institute, explained that the 'flu virus is characterized by the variability of two proteins, haemagglutinin and neuraminidase, which make up the envelope of the virus particle.
"The virus uses this variation to disguise itsef and our immune system and any vaccines we have developed just can't get a good hold on each new variant. New pandemics of 'flu , such as Asian, Spanish or the various outbreaks in Hong Kong, arise from major changes in one or other of these proteins. Often the changes are from cross-overs from other species, such as pigs or poultry, which makes it even more difficult to predict and counter new strains," he said.
CSIRO and the Biomolecular Research Institute have maintained their involvement in the project through ongoing studies to evaluate the likelihood that the virus might develop resistance to the drug. "There are grounds for optimism that resistance to Relenza TM will not occur readily," says Colman.
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Mr Doug Gale -- 03 9662 7332; email@example.com Dr Tom Spurling -- 03 9545 2470
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