News release
30 March 2006

FIT Biotech’s Investigational HIV DNA Vaccine Candidate Advances To Phase II Trial In A Joint Collaboration with Chris Hani Baragwanath Hospital, Pediatric Research Centre, Soweto, South Africa

FIT Biotech Plc a biotechnological company located in Tampere, Finland and the Perinatal HIV Research Unit, University of the Witwatersrand, located in Johannesburg, South Africa announced today the initiation of a Phase II clinical trial with a candidate HIV vaccine in treatment-naïve HIV infected individuals. This is the first therapeutic HIV vaccine trial to be conducted in South Africa with a vaccine that potentially can control or slow the progression to AIDS in HIV infected individuals. This is different to other HIV vaccine trails conducted in South Africa so far, which have been testing preventative HIV vaccines for uninfected individuals. The primary objective of this Phase II trial is immunogenicity and safety, while as a secondary objective the clinical efficacy of the candidate investigational vaccine will be evaluated.

FIT Biotech’s investigational HIV vaccine is based on its proprietary gene delivery technology. A Phase I safety studies were completed in Finland and showed an excellent safety profile for this vaccine. 

The trial is conducted at the Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.by Dr. Eftyhia Vardas  - “We are very excited about this study, the first to test a therapeutic HIV vaccine in South Africa. There is now also hope for individuals already infected with HIV since further trials with this vaccine will enable the medical community to asses the potential of this agent to control progression of HIV infection to AIDS.”

“This is an important milestone for FIT Biotech as we are advancing in our HIV vaccine development program and we are privileged about the opportunity to collaborate with such an experienced clinical research team in South Africa”, considers Dr. Kalevi Reijonen, CEO and President of FIT Biotech Plc.

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. Company has 40 employees.

The Perinatal HIV Research Unit, University of the Witwatersrand, South Africa

The Perinatal HIV Research Unit (PHRU), is an academic unit of the University of the Witwatersrand based in Soweto. The PHRU established their capability to test HIV vaccines in 2001 and to date have tested eight different preventative HIV candidate vaccines in Phase I and II.

Additional information
FIT Biotech Plc - Kalevi Reijonen;  Tel: +358 408 435 695; kalevi.reijonen@fitbiotech.com
Chris Hani Baragwanath Hospital, PHRU, Soweto, SA - Eftyhia Vardas; +27119899756; vardase@mweb.co.za

Press
Richard Hayhurst
Alto-Marketing
+44 1489 557 672
richardh@alto-marketing.com