Phase II Data from FIT Biotech's HIV Immunotherapy Show Reduction in Viral Load and Increase in CD4 Cell Count

FIT Biotech announced results today from a Phase II clinical trial

VIENNA, AUSTRIA | July 19, 2010 | FIT Biotech, a privately held biotechnology company developing novel, proprietary immunotherapies for HIV/AIDS and other viral diseases, announced results today from a Phase II clinical trial. The company’s immunomodulator FIT-06 showed unprecedented long-term reductions in viral load (approximately 0.5 log) and statistically significant CD4 cell count increases in HIV-infected, previously untreated patients. The effect lasted longer than two years in the absence of any anti-retroviral therapy.

The study, carried out in South Africa, represents the first time that an immune-based HIV intervention has reduced viremia in previously untreated patients. The results offer hope for an eventual alternative to antiretroviral therapy (ART) for those millions of HIV-infected patients in the developing world who have no access to ART. “This is the first demonstration that an immune-based therapy can interfere with HIV replication in infected people who have not yet started ART,” said Professor of Medicine Giuseppe Pantaleo of the University of Lausanne, Switzerland, an investigator on the study. “By analyzing these patients’ immune responses in detail, we will gain invaluable information to guide us in further improving the vaccine.”

“These results are very exciting as an early indicator that this approach can work. Treatment of infected individuals with an immunomodulator that can modify the course of the infection and progression to AIDS has the potential to offer hope to many chronically infected individuals in South Africa not yet eligible for antiretroviral therapy” said Dr. Eftyhia Vardas, the Principal Investigator of FIT Biotech’s clinical study. Dr. Vardas was recently nominated as Honorary Professor in the Department of Clinical Virology, University of Stellenbosch, South Africa.

“Once it has been tested in additional clinical trials, FIT-06 has the potential to offer several big advantages,” said Kalevi Reijonen, President & CEO of FIT Biotech. “Immediate benefits to patients include the possibility that the start of antiretroviral therapy could be delayed and that patients might be able to take longer drug holidays. Also, by reducing their lifetime drug burden, FIT-06 therapy might lessen the side effects associated with long-term use ofo antiretroviral therapy. Finally, FIT-06 could contribute to a slowing in the evolution of drug-resistant strains of HIV.”

The results will be presented today at the XVIII International AIDS 2010 Conference in Vienna. There will be both a poster presentation as well as a press conference featuring Drs. Pantaleo and Vardas as well as a representative of FIT Biotech.

FIT-06 is a DNA-based vaccine developed by FIT Biotech and based on FIT Biotech’s novel, proprietary GTU® technology. As a therapeutic vaccine, it is distinct from prophylactic (preventative) vaccines currently in development. FIT-06 is used to treat patients who are already infected. FIT-06 in particular and GTU technology in general represent an exciting new platform that, compared to many other HIV vaccine technologies, offers advantages such as more sustained expression of the inserted sequences, low dose requirements and an excellent safety profile. In this trial, FIT-06 was tested as a standalone treatment but in principle it could also be deployed in conjunction with ART.

The placebo-controlled Phase II study included sixty previously untreated volunteers recruited at the University of Witwatersrand Clinic in Soweto, Johannesburg, South Africa. At enrollment, patients had a plasma viral load of greater than 38,000 copies per ml and a CD4 cell count of more than 500 cells per µl. Patients were dosed either intramuscularly (IM) or intradermally (ID). The results, which were more impressive in the intramuscular group, were analyzed at the end of the study, which concluded after 108 weeks. Viral loads were reduced by 0.47 log with a p-value of 0.001 in the intramuscular group. CD4 cell counts increased by 72 cells per µl with a p-value of 0.013.

There are more than 33 million HIV-positive people in the world today, with 5.7 million in South Africa alone, including 3.2 million women. The country’s anti-retroviral programme has been in place since 2004 and more than 500,000 people have been treated.

FORUM

In addition to presenting these data in a poster session at the XVIII International AIDS Conference on July 19, FIT Biotech will be presenting its approach at a Community Forum entitled "Research Advances from Therapeutic HIV Vaccines and Other Immune-Based Therapies." The Forum takes place on Thursday, July 22 in room Schubert 5, first floor, from 9:45 to 11am.

PARTNERS

Based on these excellent results, further studies with FIT-06 are planned both in a standalone setting and in conjunction with ART. These trials will be conducted in conjunction with FIT Biotech’s public partners:

* ANRS - Agence Nationale de Recherches sur le Sida et les hépatites virales (www.anrs.fr);
* HVTN – HIV Vaccine Trial Network (www.hvtn.org)
* Imperial College London (www.imperial.ac.uk), Medical Research Council
* EU-FP7, EU Framework 7 Funded Large Integrated Project CUT’HIVAC (http://cordis.europa.eu/fp7)

ABOUT FIT BIOTECH

FIT Biotech (www.fitbiotech.com) is an innovative medical biotechnology company based in Tampere, Finland and Tartu, Estonia. FIT Biotech is developing and commercialising its proprietary Gene Transport Unit (GTU®) technology including FIT-06 for HIV/AIDS. Other GTU product applications include novel DNA vaccination and immuno- and gene therapies for other infectious diseases including neglected and emerging diseases with high unmet medical need.

SOURCE: FIT Biotech Ltd.

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