VIENNA–(Business Wire)–
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.
FIT Biotech Ltd.
Dr. Kalevi Reijonen, + 358 408 435 695
CEO & President
kalevi.reijonen@fitbiotech.com
Web: www.fitbiotech.com
Copyright Business Wire 2010