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
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