"The first winter cold and flu treatment that may actually work" is how UWA researchers describe the medication they are testing over winter.
Associate Professor Manfred Beilharz, Chair of Discipline, Microbiology and Immunology (School of Biomedical, Biomolecular and Chemical Sciences), Clinical Professor David Smith (Division of Microbiology and Infectious Diseases/ Medical Microbiologist, PathWest) and UWA PhD student Alayne Bennett are running a clinical trial of some 200 people to confirm the effect and safety of oral low dose interferon alpha, a naturally-occurring protein which inhibits respiratory viruses of most kinds in humans and other mammals. "If this trial works as cleanly as we think it will, it won't take long before the tablets are on the pharmacy shelf,"
A/Professor Beilharz said. "And it should be inexpensive - the tablets we are using in our trial are very cheap to manufacture, particularly in comparison to Tamiflu and Relenza, the current antivirals in use."
A cure at last for the common cold? Not quite, but perhaps the best preventative treatment yet.
"Swine flu provided a tremendous bonus for us," the investigators said. "It made people nervous and the enrolments in our clinical trial soared. We hoped we would have 80 people taking the interferon tablet and 80 taking a placebo, but we have nearly 200 altogether."
The trial, mostly funded by the Health Department of WA, is double-blinded, that is neither the participants nor the researchers know who is taking which tablet. There are two clinicians (the required safety monitoring board for such clinical trials) who do know which volunteers are taking the interferon, and they monitor the weekly online health diaries of participants.
The oral low dose interferon story began more than 20 years ago when a vet in Texas discovered interferon in the nasal secretions of cows developing respiratory infections during shipping. This led to the development of a theory that interferon in the nasal secretions was part of an early warning system, telling the body that a virus had entered the system via the nose.
A/Professor Beilharz pioneered research in support of this notion, but acceptance by mainstream medicine has been slow.
In the late 1960s and early 1970s, the Soviets claimed they had great success with intra-nasal interferon drops for colds and flu but subsequent tests in the West in the 1980s showed it did not work.
"But this was probably because they were using very high doses of oral interferon. More is not always better in these situations mimicking a natural process. Also the Western tests used large viral challenges which again do not mimic a natural infection," said A/Professor Beilharz.
The tablets in this trial contain 150 international units of interferon alpha, a tiny amount when compared with doses of 1.5 million international units injected into patients with Hepatitis C, Multiple Sclerosis and some cancers.
"As well as the Health Department funding, the American pharmaceutical company Amarillo Biosciences Incorporated has supplied the tablets for the trial free of charge and also the web-based data collection system we are using. We didn't really have a sufficient budget to conduct this clinical trial but our laboratory results with mice were so stunning that we just had to. Better to run it on a shoestring than not at all," he said.
"Alayne did a grand job of recruiting for the trial, focusing on occupationally exposed people including kindergarten teachers, GPs, hairdressers and hospital receptionists, spending very little money on advertising, and doing a lot of leg work."
The cohort is now taking a tablet every day for three-and-a-half months. Towards the end of October, the study will be unmasked and the data analysed. "We will publish as soon as possible thereafter," A/Professor Beilharz said.
He expects his American colleagues to conduct a bigger follow-up clinical trial in the US during the coming northern cold and flu season. In the meantime, the NHRMC has offered additional funding for research undertaken before December that can influence public policy regarding swine flu (H1N1) here in Australia.
"We have put our hand up because, with a clinical trial already in place, it would be easy for us to send out swabs and ask our participants to take a nasal swab if they have a runny nose," he said.
This addition to the protocol will allow effectiveness against swine flu to be simultaneously evaluated.
This story is featured in UWA NEWS 27 July 2009 Volume 28 Number 10