Viral Genetics says optimal dose not yet identified for VGV-1

By Elaine Rigoli

Tampa, Fla., June 19 - Viral Genetics, Inc. said the results of its 137-patient "TNP-001" clinical trial of VGV-1 were consistent with the company's four prior prospective clinical studies of VGV-1, confirming immunological bioactivity and antiviral properties while also suggesting that the optimal dose has not yet been identified and requires further study.

Specifically, the company said the results indicate that a proportion of patients receiving eight weeks of treatment with VGV-1 and no additional anti-HIV therapy experienced a decrease in viral load measured by polymerase chain reaction (PCR) at day 150 that diminished at day 240.

Additionally, VGV-1-treated patients demonstrated positive changes in immune markers associated with HIV infection and proviral peripheral blood mononuclear cells (PBMCs).

Proviral PBMCs are cells that have been infected with HIV and produce additional copies of the virus, according to a news release.

Viral load endpoints were measured by PCR twice at baseline, during treatment at day 23 and 51, and post-treatment at days 90, 120, 150 and 240.

There were statistically significant reductions in the PCR viral load in 22.2% of treated patients (14 patients) at day 150 with a 0.5 log or greater drop in viral load at this time versus 6.25% (3 patients) for patients on a placebo.

This effect diminished at day 240 where results were not statistically significant, the release said.

This analysis excluded patients who received antiviral medications due to severe deterioration of CD4 counts or development of full-blown AIDS.

Viral load did not show statistically significant changes during treatment, or afterwards at day 90, day 120 or day 240.

A 0.5 log decrease is roughly equivalent to a 70% decrease in the amount of virus in the blood.

Accordingly, at day 150, which is about three months after completion of treatment, 22.2% of patients receiving VGV-1 had a decrease of about 70% or more in the amount of blood-borne virus as compared to 6.25% of the placebo patients.

Viral Genetics is a drug-development company based in Azusa, Calif.

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