November 30 2002, Press release
FIT Biotech Plc announced today results of its Gene Transport Unit (GTU®) technology based DNA vaccine aimed for use in prevention and therapy of the human immunodeficiency virus (HIV) infection. FIT Biotech's investigational vaccine (GTU®-Nef) was able to induce cell-mediated immune response in HIV-infected patients. The investigational vaccine was well tolerated and no safety concerns were raised. The company believes that the results of the first Phase I/II study confirms the proof-of-concept for its novel DNA vaccination technology(GTU®) and its HIV vaccine product line.
HIV infection is characterized by a strong antibody response to HI-virus but low or lacking cell- mediated immune response towards HIV-infected cells. It is believed that a strong cell-mediated response could either prevent infection in non-infected individuals or have a favorable effect on the clinical course in those already infected with the virus.
One way to induce a cell-mediated immune response is so called genetic vaccination, in which either viral vectors or naked DNA vectors that express some of the proteins of the virus are used. FIT Biotech has used its proprietary GTU®-Nef vaccine, a DNA vector expressing Nef, which is one of the regulatory proteins of HIV. In infected cells, Nef is expressed early during viral cycle and therefore an immune response to Nef could destroy infected cells before they release new infectious viral particles capable of spreading the infection in the body.
FIT Biotech is performing clinical trials among HIV infected and non-infected healthy volunteers with the preventive and therapeutic HIV vaccine developed by the company. This information was released for the media on the 30.11.2001 and 13.09.2002.
FIT Biotech's clinical trial among HIV infected patients is based on its investigational vaccine (GTU®-Nef) and was performed at Helsinki University Central Hospital in Finland. In the phase I/II clinical trial, 14 voluntary HIV-infected patients, who also received anti-retroviral therapy (HAART), received three different doses of the investigational GTU®-Nef vaccine. The doses were 1, 20 or 400 micrograms given intramuscularly twice within two weeks. The vaccinated persons were then followed up for 12 weeks clinically and by an extensive pattern of laboratory measurements to study the safety and tolerability of the vaccine and whether it would induce an HIV-specific cell mediated immune response.
FIT Biotech´s GTU®-Nef vaccine trial was used to test the proof-of-concept trial for GTU® technology and HIV vaccine product pipeline, and it is not intended as the final HIV vaccine product. The company is currently developing multiepitope HIV vaccines, based on the GTU®-technology and including Nef protein, and is planning to start new clinical trials in 2003.
None of the vaccinees showed signs nor symptoms of any adverse effects. GTU® technology based vaccine (GTU®-Nef) can thus be declared well tolerated. In immunological assays, more than half of the vaccinees showed a cell-mediated immune response towards HIV-1 Nef. Most importantly, this favorable response was seen even with the lowest dose used, 1 micrograms in four out of five vaccinees.
This dose is less than 1/1000 of the doses that other groups developing DNA vaccines have been used in order to obtain an immune response in their vaccine trials. The fact that very low doses can be used with FIT Biotech´s GTU®-vectors may have favorable effect on safety profile of the vaccine and it may have significant impact on the development of cost effective vaccines for developing countries.
FIT Biotech Plc is an innovative medical biotechnology company engaged in the development and commercialisation of its proprietary Gene Transport Unit (GTUÒ) technology and GTUÒ's product applications in DNA vaccination and immune therapy. The Company's other areas of expertise are artificial immunogen (multiepitope), recombinant protein and antibody technologies, and GMP class process development for DNA based vaccines. In addition, the Company has developed and launched diagnostic products for the detection of natural latex allergens. The Company was established in 1998 and is located in Tampere, Finland, with operations also in Tartu, Estonia, and in Bangkok, Thailand.
CEO & President Pekka Sillanaukee
Tel. +358 3 3138 7000
Fax +358 3 3138 7050
Mobile +358 40 833 1313
Prof., SVP Vaccine BA Kai Krohn
Tel. +358 3 3138 7000
Fax +358 3 3138 7050
Mobile + 358 40 833 1366
www.fitbiotech.com /news/news in Finnish/ Press release of FIT Biotech Plc in Friday November 30th, 2001 and September 13th, 2002 www.iavi.org /need for a vaccine
Appendix: Reference IAVI - Wold needs a HIV vaccine
• More than 25 million men, women and children have died from AIDS.
• AIDS now kills more people worldwide than any other infectious disease.
• More than 40 million people are living with HIV. Nearly all will die from AIDS- related complications within the next two decades.
• An estimated 5 million people were newly infected with HIV in 2001.
• More than 13 million children worldwide have been orphaned by AIDS. Their numbers are expected to top 40 million in the next decade.
• More than 95% of all new infections are in developing countries, making HIV/AIDS among the most serious threats not only to global health, but to global development.
• Prevention programs-including education, condom and clean needle distribution and peer counseling-have slowed the spread of HIV, but have not stopped it.
• Treatment advances have yielded important new AIDS therapies, but the cost and complexity of their use put 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.
Only an HIV vaccine can end the HIV/AIDS pandemic.