FIT Biotech, a medical technology company based in Finland, plans to begin testing an HIV vaccine on human subjects sometime after the spring of 2014. Hundreds of HIV-positive patients in France and Switzerland will participate in the trials, which are expected to last several years before the company applies to the FDA and its European equivalent the EMA. In previous non-human testing, the vaccine has been shown to stop the progression of the virus and even eliminate it entirely.
Currently it costs HIV patients up to $20,000 a year for drug treatment of the disease. If the vaccination works as expected, it could reduce costs up to 10 times. On top of that, the company believes that the vaccination could eventually be used as a preventative measure to help stop the spread of the disease, although that use could be at least a decade away.
FIT Biotech doesn’t plan on manufacturing the drug once human testing is complete. Instead, they will license the technology to a production partner. “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 Kalevi Reijonen, FIT Biotech’s CEO.
The great thing about the vaccine is that it works with the body’s own system to fight the disease, creating a controlled immune response. The vaccine is purely DNA-based, which means that it is gentle on the body. “There is not much to cause side-effects and the effect mechanism on the human body is also gentle,” Reijonen says.