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November 30 2001, Press release
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| FIT Biotech's novel gene technology based HIV/AIDS vaccine enters human studies |
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| Summary |
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FIT Biotech Plc announced today that the company will initiate Phase I clinical trial testing with its unique Gene Transport Unit (GTU™) technology based DNA vaccine aimed at use in prevention and therapy of the human immunodeficiency virus (HIV) infection. The trial is designed to test the safety and tolerability of FIT Biotech's investigational vaccine (GTU™-Nef) among HIV -infected human volunteers.
"Completion of the pre-clinical phase of product development and entering human studies allows FIT Biotech to document the proof-of-concept for it's novel GTU™ technology platform and is a significant milestone in the development of the preventive and therapeutic HIV-vaccine" says CEO & President Pekka Sillanaukee.
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| The first DNA vaccine study in Finland |
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FIT Biotech Plc announced today that the company will initiate Phase I clinical trial testing with its GTU™ technology based DNA vaccine aimed at use in prevention and therapy of the human immunodeficiency virus (HIV) that causes acquired immunodeficiency syndrome (AIDS). "The National Agency for Medicines in Finland has approved FIT Biotech´s clinical trial notification on 20th November 2001, which means that the trial may be commenced" says Ms. Ioana Stanescu, M.Sc., the Director of Regulatory Affairs and Project Management of FIT Biotech.
The trial, which will start within two months at the Department of Dermatology and Venereology of Helsinki University Central Hospital is designed to test the safety and tolerability of FIT Biotech's investigational vaccine (GTU™-Nef) among HIV -infected human volunteers.
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| FIT Biotech offers unique vaccine products |
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Vaccines are generally recognized as the most cost-effective way to prevent infectious diseases. However, the technical limitations of conventional vaccine approaches have constrained the development of effective vaccines for many diseases. FIT Biotech's unique vaccine products are based on a novel Gene Transport Unit (GTU™)technology that may offer a new technology platform for many therapeutic and preventive vaccine applications.
"Completing the pre-clinical phase of product development and entering the phase of human studies allows FIT Biotech to document the proof-of -concept for its novel GTU™ technology platform and is a significant milestone in the development of the preventive and therapeutic HIV-vaccine" says CEO & President Pekka Sillanaukee, PhD, eMBA.
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| Intensive and long discovery history behind HIV vaccine |
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"FIT Biotech and it's researchers have, for a long time, been committed to developing HIV/AIDS vaccines for a global need" says FIT Biotech's Senior Vice President of Science & Technology, Professor Kai Krohn MD, PhD, who together with Professor Annamari Ranki, MD, PhD, started HIV research in 1983, HIV vaccine research in 1987, and DNA-based HIV vaccine studies in 1992. FIT Biotech has participated in the first HIV vaccine program co-ordinates by the EU's Science & Technology program since 1996 and its vaccine development is supported by the National Technology Agency of Finland. The product design is based on the intensive work of experts in Finland, Estonia, Sweden, Germany and the USA coordinated by Prof. Kai Krohn and by FIT Biotech's Vice President of Vaccine Design Development, Professor Mart Ustav, PhD. The prototype vaccine has been developed in FIT Biotech's development facilities in Finland and Estonia.
Clearly, vaccination is a cost-effective weapon for disease prevention but despite unprecedented efforts, no effective vaccine has yet been developed against HIV. Since the days when HIV was discovered, a lot has been learned about the immune system and virus-targeted immune responses. One of the most important issues is that an effective vaccine should generate two kinds of immune responses; humoral or antibody-mediated immunity, which neutralizes free infectious particles and cellular or cell-mediated immunity which destroys infected cells. Also, selection of the target protein (immunogen) for the vaccine and the route of administration of the vaccine are important.
During HIV infection, viral regulatory proteins are expressed prior to the structural viral proteins. One of the regulatory proteins is Nef, which seems to have several advantages that can be used in vaccination. Although only a few molecules of Nef are present in the infecting virion, more Nef is produced soon after the virus has entered the cell and even before the viral structural proteins are expressed. This makes the Nef protein a tempting candidate for vaccine development as an immune response directed against it may destroy the infected cells before infective virions are released. Nef is also the most immunogenic of HIV-1 non-structural proteins: more than 70% of HIV-1 positive individuals show anti-Nef antibodies and cell-mediated responses have been reported on several occasions. In humans, cell-mediated immune responses towards Nef have been shown to be associated with protection.
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| The concept of DNA vaccine |
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"GTU™ has a specifically designed circular plasmid DNA structure capable of long term and high level expression of the selected immunogen making it useful as a vaccine" says Prof. Mart Ustav, the Vice President of Vaccine Design and Development in FIT Biotech.
DNA or genetic immunization is a new approach of vaccination where the immune response to a protein is induced by direct inoculation of a DNA plasmid that encodes the desired foreign antigen. In contrast to classical vaccines that contain the antigenic material itself, DNA vaccines provide host cells with the genetic code for the intracellular synthesis of the immunizing antigens. The DNA vaccine thus mimics the natural infection as it encodes the antigenic material that is then synthesized in the host cell but, importantly, does not cause infection.
DNA vaccines have several advantages over classical vaccines; 1) the immunizing antigenic protein is produced inside the host cell, and thus it acquires a correctly folded antigenic conformation, whereas, in case of classical vaccines the purification process can disrupt or alter the native structure or simply may allow only a suboptimal posttranslational modification of the antigen. 2) The DNA immunization allows intracellular processing of the immunized protein that in turn will support the processing and presentation of the antigen not only by MHC Class II molecules but also by MHC Class I molecules that result in induction of cytotoxic T-cells. The cytotoxic T-cells are required in the killing of pathogen-containing cells such as HIV-infected CD4+ T cells. Direct injection of DNA plasmid containing antigen-encoding cDNA has been shown to induce an immune response with a strong CTL response and occasionally, depending on the plasmid and antigen used, also a high antibody response.
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| The world needs an HIV/AIDS vaccine |
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More than 36 million people are living with HIV and the epidemic is rapidly expanding. Nearly all of them will develop AIDS-related complications within the next two decades. 16,000 people become infected with HIV every day. More than 13 million children worldwide have been orphaned by AIDS. Their number is expected to top 40 million in the next decade.
Prevention programs - including education, condom and clean needle distribution and peer counseling - have slowed the spread of HIV, but have not stopped it. Drug development efforts have yielded important new AIDS therapies, but the cost and complexity of their use puts them out of reach for most people in the countries where they are needed the most. In industrialized nations where drugs are more readily available, side effects and increased rates of viral resistance have raised concerns about their long-term use. It is widely believed that only an HIV/AIDS vaccine can end the HIV/AIDS pandemic.
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| General information about the company |
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FIT Biotech Plc is an innovative medical biotechnology company engaged in the development and commercialization of analytical and diagnostic products and novel DNA-vaccines for unmet clinical needs. The products are based on the company's Gene Transport Unit (GTU™), recombinant protein and antibody technology platforms. FIT Biotech Plc established its current operations in 1998 and is located in Tampere, Finland and in Tarto, Estonia.
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Tampere, 30th November, 2001
FIT Biotech Plc
Pekka Sillanaukee
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| Additional Information |
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Mr. Pekka Sillanaukee
CEO and President
FIT Biotech Plc.
Tel. +358 3 3138 7000
Fax +358 3 3138 7050
Mobile +358 40 833 1313
pekka.sillanaukee@fitbiotech.com
www.fitbiotech.com
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