The study will test the vaccine's efficacy at reducing the viral load of current HIV patients, in conjunction with AIDS medication.
The Tampere-based biotechnology company plans to begin testing some time after spring 2014. Previous tests have shown that the vaccine may have the ability to stop the progression of the disease, or at best to eliminate the HIV virus completely.
The company is working in collaboration with two leading European Universities, in addition to one or two large American pharmaceutical companies, according to medical doctor and FIT Biotech’s CEO, Kalevi Reijonen.
“The study will last two to three years. Then, of course, applications will be made to the FDA in the USA and the EMA in Europe to authorise the marketing of the drug,” explains Reijonen. “Dealing with the regulations may take a year and a half. So we’re still looking at about five years before the drug would become available.”
Some 1,000 patients throughout France and Switzerland will take part on the trials, with the first phase involving hundreds of HIV sufferers. Participant numbers will increase as the programme progresses.
Revolutionising HIV treatment
FIT plans to test the efficacy of the vaccine when used in conjunction with AIDS medication. If all goes well, the vaccine should be approved and will become available within 5 years.
Reijonen claims that the medication will revolutionise the treatment of HIV. At present, the drug related medical treatment of an HIV-patient in an industrialised country costs some 10-15,000 euros per year. With vaccination, the cost could be around a tenth of that figure.
FIT Biotech does not intend to manufacture the vaccine for sale itself, but will license production to a partner.
The company expects the vaccine to generate advance payments of tens of millions of euros and to attract royalties in the realm of hundreds of millions of euros every year.
“Our licensing negotiations will certainly be launched early next year because when these studies begin an agreement must also be negotiated. So, we are trying to move forward now on quite a tight schedule,” says Reijonen.
GTU technology "gentle on the body"
According to Reijonen, the GTU technology developed by FIT Biotech is also suitable for use as a preventive HIV vaccine, however, he says that such a drug is still ten years away.
The central idea behind HIV vaccine development is the use of genetic immunization. Genes are introduced into the body in order to generate a controlled immune response against HIV. Gene Transport Unit (or GTU) technology refers to FIT Biotech’s patented method by which genes can be safely introduced into the body.
“It could be described as a lorry that transports the load required for treatment or prevention into the body,” describes Reijonen.
According to him, GTU technology has a great advantage compared to earlier methods, in that the vaccine is pure DNA.
“There is not much to cause side-effects and the effect mechanism on the human body is also gentle,” Reijonen adds.