FIT Biotech to present results of FIT-06 Phase II clinical trial at XVIII International AIDS 2010 Conference

Jul 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.

“This is the first demonstration that an immune-based therapy can interfere with HIV replication in infected people who have not yet started ART”

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.