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New technology to combat HIV and tuberculosis

The success of a Phase II clinical trial in South Africa using an immunomodulator from FIT Biotech is the first time that an immune-based HIV intervention has reduced viremia in previously untreated patients.

There are more than 33 million HIV-positive people around the world and some 5.7 million people in South Africa alone. Many other countries in Africa are also facing major problems with the disease.

While most HIV vaccine efforts have been aimed at developing a preventive HIV vaccine to protect non-infected individuals against future exposure, vaccinating individuals already infected offers the best hope for chronically infected individuals not eligible for antiretroviral therapy (ART). This is especially important in South Africa, since access to ART through publicsector health care there is limited.

The South African trial is the first demonstration that an immune-based therapy can interfere with HIV replication in infected people who have not yet started ART.
A vaccine that can modify the course of the infection by maintaining a low viral load and high or constant CD4 cell counts is needed to do this. To address the ability of the virus to mutate rapidly, FIT Biotech has used its novel GTU® vector technology to produce the FIT-06 immunomodulator. This is based on an antigenic artificial protein composed of sequences from six HIV genes with antigens from the A, B, C, and FGH HIV clades and estimated to cover more than 95% of the theoretical antigenic variability within HIV strains.

A Phase II therapeutic clinical trial with 60 treatment-naïve HIV-infected individuals in Soweto by the University of Witwatersrand’s Perinatal HIV Research Unit showed a significant reduction in viral load and an increase in CD4 cell counts in vaccinated individuals. The door is now open for Phase IIB/III studies to confirm the clinical efficacy of the product. While FIT-06 was tested as a standalone treatment, it could in principle also be deployed in conjunction with ART where appropriate.

Phase II therapeutic trials have started in Britain and France with people infected with HIV and already on medication for the disease, while Phase I trials are scheduled in the US for people who have not been infected.

A powerful platform

FIT Biotech’s GTU® technology platform – which lies behind the FIT-06 immunomodulator used in the South African trials – is based around a special DNA plasmid capable of delivering selected genes to human cells.In addition to providing up to 100 times stronger and more persistent gene expression than standard plasmids, it offers versatility, cost-efficient production opportunities, together with freedom from the safety risks typical of viral vectors.

In addition to HIV, GTU® technology is also being used to develop a more efficient vaccine against tuberculosis than the existing BCG vaccine. Based on an immune response induced by genes of mycobacterial origin, a DNA vaccine using GTU® technology has the potential to elicit long-lasting, cell-mediated immunity.

Tuberculosis remains a major global health problem, as a third of the global population is estimated to be infected with mycobacterium and almost 2 million people die of tuberculosis annually.

> Kalevi Reijonen
(Published in HighTech Finland 2011)