FIT Biotech Oy: FIT Biotech’s HIV vaccine demonstrated to be safe and well tolerated in two clinical studies


Company announcement
June 9, 2016 at 2.40 pm

FIT Biotech's HIV vaccine demonstrated to be safe and well tolerated in two clinical studies

Robust immune response with viral inhibition reported in one study. New gene-based immunotherapy will be further tested in clinical studies by the European HIV Vaccine Alliance Consortium.

Finnish biotechnology company FIT Biotech Oy's (Nasdaq Helsinki: FITBIO) experimental HIV vaccine, FIT GTU® HIV vaccine, has been clinically tested by two leading European HIV research centers with encouraging results. According to these two investigational studies, FIT Biotech's DNA vaccine was found to be safe and well tolerated.

The Imperial College, London, recently completed a preventative Phase 1 study in 30 healthy subjects comparing multiple routes of administration of FIT GTU® HIV vaccine on cellular immune response. Viral inhibition was seen in all groups with the highest and broadest inhibition after intramuscular administration enhanced by electroporation. These results confirm that FIT Biotech's HIV DNA vaccine is able to induce relevant immune responses associated with viral inhibition. The therapy was also found to be safe and well tolerated.

ANRS, Paris, recently completed a Phase 2 study of FIT GTU® HIV vaccine that enrolled 103 HIV-infected patients to assess safety when combined with Lipo-5 vaccine. A prime and boost regimen of FIT GTU® HIV vaccine combined with ANRS Lipo-5 vaccine also looked at possible effect on HIV reservoir. Preliminary safety data indicate that the vaccines were not associated with major clinical or biological safety concerns. All patients showed viral rebound after analytical treatment interruption.

FIT Biotech's HIV DNA vaccine will be tested in additional clinical trials sponsored by the European HIV Vaccine Alliance. These studies are funded by the EU-Horizon 2020 program. The HIV consortium plans to test the effect of immunological intervention on the HIV reservoir with a novel study design.

FIT GTU® HIV vaccine is based on the company's patented vector technology, GTU® (Gene Transfer Unit vector), which the company is now also testing in gene-based treatments for expression of therapeutic proteins such as monoclonal antibodies commanding multi-billion dollars of sales.

FIT GTU® HIV vaccine was shown in a previous Phase 2 clinical study conducted by the company to have statistically significant log reductions in HIV titers while increasing CD4+ T cell counts.

"We are highly encouraged by these two clinical studies of FIT GTU® HIV vaccine," said Dr. James Kuo, CEO, FIT Biotech. "The studies conducted by these two leading European HIV research centers demonstrated that the therapy was safe and tolerable. We look forward to the publication of these results in peer-reviewed scientific journals."


Further information:
James Kuo
CEO, FIT Biotech Oy
Tel: +358 3 3138 7000

Certified Advisor: Translink Corporate Finance Oy, tel. +358 20 743 2790

FIT Biotech in brief
FIT Biotech Oy is a biotechnology company established in 1995 that develops and licenses its patented GTU® (Gene Transport Unit) vector technology for new-generation medical treatments. GTU® is a gene transport technology that meets an important medical challenge in the usability of gene therapy and DNA vaccines.

FIT Biotech applies GTU® technology in its drug development programmes. Application areas include cancer (gene therapy) and infectious diseases such as HIV and tuberculosis, as well as animal vaccines.

FIT Biotech shares are listed on the First North Finland market maintained by Nasdaq Helsinki Oy.

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