Viral Genetics announced today that the results of a clinical trial of its investigational therapy for HIV infection, VGV-1, were recently published in a peer reviewed journal, HIV & AIDS Review.
The investigators observed that in patients failing anti-retroviral drug therapy, treatment with VGV-1 for sixty days was associated with undetectable viral load (level of virus in the blood as measured by HIV RNA) in half of the patients (5/10) within three months of treatment. Furthermore, by six months there was an average one-log drop in virus levels. VGV-1 (formerly called TNP) is a purified protein extracted from mammalian thymus tissue through a proprietary process.
The trial in Mexico enrolled 10 HIV positive patients who were failing to respond to their second or third regimen of anti-retroviral drug therapy. Patients develop resistance to current regimens of anti-retroviral therapy because of the HIV virus's ability to mutate. This resistance results in declining efficacy of anti-retroviral therapy and increases in viral load. Enrolled subjects in the Mexican study, had been receiving anti-retroviral therapy but were demonstrating decreasing viral control, and received VGV-1 injections twice weekly for eight consecutive weeks. They were then followed for safety and efficacy on markers of disease progression such as HIV-1 RNA (viral load or virus in the blood) for six months.
The authors of this study, commenting on these results, said, "Our patients had been suffering from advanced stages of their disease, and conventional anti-retroviral strategies applied to them were failing until we used TNP. This is a preliminary study, and it shows that TNP therapy may be safely associated with other antiretroviral therapies, and may therefore have value in promoting the available therapeutic combination when antiviral drugs fail. The availability of complementary medications such as TNP is desirable, considering that some 30% of patients fail to suppress their HIV infection despite the use of potent combined therapy."
The Company believes that publication of this study supports the investigational use of VGV-1 as a potential salvage therapy for treatment of HIV infected people who have failed anti-retroviral therapy. The study additionally supports the Company's efforts to develop strategic partners and pursue Investigational New Drug status in the United States.
Further details on this study can be found on the Company's web site or emailing [email protected]
VGV-1 is currently being studied in a multi-center randomized double blind trial in South Africa. The Medicines Control Council of South Africa has designated this trial "Phase III." For more information on this trial, please see the company's press release on August 3, 2004.