A promising prospective treatment for HIV infection and AIDS studied in several clinical trials, VGV-1 is a suspension of TNP in adjuvant administered through 16 intra-muscular injections over an eight-week period. The recent South African Phase III trial showed a statistically significant antiviral effect in a group of patients three months after the last treatment. Click here for a sample chart: Percent_Responders.PDF. In a subgroup of patients with lower CD4 counts (less than 300), the effect seemed stronger and persisted through to 6 months post-treatment. Click here for a sample chart: CD4_Responders.PDF.

Five human clinical trials outside the US have been conducted with HIV infected individuals with varying viral load and CD4 levels, who were treatment-naïve as well as those off antiviral drugs, multi-drug resistant or on failing ART regimens. These studies suggested VGV-1 is well-tolerated and associated with decreasing viral load.

The current approach to treatment of HIV/AIDS involves the use of antiretroviral drugs and combinations of them. These drugs are very effective at controlling the levels of virus and prolonging life, but they do carry significant side effects, have sometimes complex dosing regimens, are usually quite expensive, and require daily ingestion of pills indefinitely. All drugs approved for treatment of HIV infection work by directly affecting the virus itself, whether its reproductive cycle or its ability to enter the immune system cells it hijacks in order to propagate.

Unlike other HIV/AIDS treatments, VGV-1 appears to have minimal side effects, an apparent immunological mechanism, minimal compliance issues, and is projected to be cost-effective. Because a treatment cycle with VGV-1 consists of just 16 injections, it is substantially less expensive than ART or HAART which require that drugs be taken once a day, or even more frequently. VGV-1 also appears to work through a mechanism that involves the use of the immune system, rather than attacking the virus itself. We are still working to understand this, but we believe VGV-1 is markedly different than existing anti-HIV drugs.

We believe that the current dosing of VGV-1 may not yet be optimized and could possibly be improved to generate a stronger result in controlling virus. We believe that we may be able to accomplish this as a result of our research and the technology we recently licensed from the University of Colorado. In essence, optimization means adjusting the dosing amounts, timing and frequency in an effort to achieve a better, stronger result in more patients.

With over 40 million cases of HIV in the world and growing, including over 25 million in Sub-Saharan Africa alone, we believe that such an optimized therapy with the apparent advantages it could have would be of significant interest.

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