Reports and Releases
FIT Biotech Oy: EHVA starts recruiting participants to clinical trial testing FIT Biotech’s vaccine
FIT Biotech Oy
Company release 27.11.2018 at 03:00 PM EET
EHVA starts recruiting participants to clinical trial testing FIT Biotech's vaccine
European EHVA-vaccine alliance (European HIV Vaccine Alliance, EHVA) starts clinical trials including FIT Biotech Oy's ("Company", FITBIO: FN Finland) therapeutic HIV vaccine candidate, FIT-06 by initiating recruitment of participants in Switzerland.
Evaluation of the safety and preliminary efficacy of FIT Biotech's FIT-06 vaccine is scheduled to start in six European countries in a multicentric phase I/II trial coordinated by EHVA. The clinical study will evaluate in participants living with HIV a prime-boost vaccination regimen of FIT-06 with an MVA-based vaccine candidate (developed by the French research institute ANRS) in combination with an immunotherapy drug. FIT-06 is used as the priming vaccine to induce immune responses. Clinical trial applications have been approved in Great Britain and Switzerland. Additional trial approvals are expected in four other EU-countries. The final study results are anticipated to become available in 2021.
CEO Erkki Pekkarinen comments:
"Commencing the clinical trial evaluating FIT-06 by starting participant recruitment marks a major milestone for FIT Biotech. We are extremely proud of our pivotal role in the EHVA-consortium and its research for therapeutic HIV vaccines. Subject to the outcome of the clinical trial, a new therapy may be developed as an alternative to conventional therapy with antiviral drugs. Our objective is to offer people living with HIV a cost-effective, efficacious and safe treatment with no need for daily intake of antiviral drugs. Positive results would also represent an important breakthrough for FIT Biotech in business development, future product development as well as commercialization."
Worldwide, almost 37 million people are living with HIV and approximately 2 million new infections occur every year. The Company's clinical stage candidate FIT-06 aims to contribute to addressing challenges of standard therapies that include restricted access to medication, continuous patient retention in lifelong therapy, social stigma and side effects. There is a need to provide a safer and more cost-effective alternative to current HIV therapies.
For further information please visit: http://www.ehv-a.eu/news
FIT BIOTECH Oy
Board of Directors
For further information:
CEO Erkki Pekkarinen
Tel: +358 44 027 0080
Certified Advisor: Aalto Capital Partners Oy, tel. +358 40 587 7000
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 its GTU® technology in its development projects, which at the time include gene-based treatments, genetic vaccines and research collaboration. Application areas include cancer (gene therapy) and infectious diseases such as HIV.
FIT Biotech K-shares are listed on the First North Finland market maintained by Nasdaq Helsinki Ltd.
The European HIV Alliance (EHVA) is a five year project funded by the European Union's Horizon 2020 Research and Innovation Programme and the Swiss government, and designed to foster the development of an effective vaccine to prevent HIV infection and AIDS. The Alliance encompasses 39 academic, non-profit, community and industry partners from across Europe, as well as partners from sub-Saharan Africa and North America. The multidisciplinary team encompasses all aspects of vaccine development from early-stage discovery to clinical trials, and its work will build on the latest advances in preclinical and clinical vaccine development. For more information about the EHVA, please visit: www.ehv-a.eu