News release
31 August 2007

Preliminary results of therapeutic AIDS vaccine trial presented

Tampere, Finland - FIT Biotech Plc, a Finnish biotech company developing therapeutic and preventive HIV vaccines as well as other novel DNA based products using proprietary technology and the Perinatal HIV Research Unit (PHRU) of the University of the Witwatersrand joined forces to test the first Phase IIA therapeutic HIV vaccine trial in South Africa. This is a single-centre, single-blinded Phase IIA study that enrolled 60 individuals to test the safety, routes of administration and doses required for the vaccine. Initial Phase I safety studies conducted in Finland confirm that the vaccine has an excellent safety profile. The vaccine also known as the first generation GTU®-MultiHIV B clade vaccine can potentially control and ultimately delay the progression to AIDS in HIV infected people. According to the Principal Investigator of the study Dr. Eftyhia Vardas, Director of the HIV AIDS Vaccine Division at the PHRU, it is hoped that the vaccine can control an individual’s viral load at very low levels decreasing the risk of transmission and ultimately help to increase CD4 counts, the health defense cells needs to combat progression to AIDS. “It is very exciting to be working on a therapeutic vaccine in South Africa. Most vaccine efforts to date have focused on preventative vaccines for HIV negative people, but given that almost 5 million people are already living with HIV in South Africa something, in addition to treatment needs to be done”.

Preliminary results of the ongoing Phase IIA clinical trial were recently presented at the AIDS Vaccine 2007 Conference in Seattle, Washington and included a review of the safety and viral load data up to the completion of visit 8 (week 16). FIT Biotech’s investigational vaccine GTU®-MultiHIV B clade was safe and well tolerated. Clinically, the vaccine has a significant impact on the mean change in log viral load overtime for vaccine participants compared to placebo participants. “The preliminary results are very encouraging and continued follow up is necessary to assess whether the clinical responses seen so far are sustainable, maintaining low viral load and steady CD4 counts and to assess the effects of further vaccine boosts on the cellular immune response” commented Dr. Kalevi Reijonen, CEO & President of FIT Biotech. Two further vaccinations or boosts are scheduled for participants as well as continued follow up of all individuals to assess the sustainability of the preliminary responses seen so far. 

For additional information
FIT Biotech Plc
Kalevi Reijonen, CEO & President
Tel: +358 408 435 695
kalevi.reijonen@fitbiotech.com

About FIT Biotech Plc. 
FIT Biotech (www.fitbiotech.com) is an innovative medical biotechnology company based in Tampere, Finland and Tartu, Estonia engaged in the development and commercialisation of its proprietary Gene Transport Unit (GTU) technology and GTU product applications in DNA vaccination as well as in immuno- and gene therapies. The Company has 40 employees.