Phase II data on Genetic Immunity's DermaVir vaccine to be presented at XVIII International AIDS Conference

Genetic Immunity, a US/Hungarian biopharmaceutical company developing nanomedicine-based immunotherapies for HIV/AIDS and other chronic diseases, is releasing Phase II data on the Company's novel DermaVir therapeutic vaccine for HIV/AIDS during the XVIII International AIDS Conference this week in Vienna, Austria. DermaVir, the first dendritic cell-targeting topical HIV vaccine candidate, employs nanotechnology to induce multi-faceted and long-lived immune responses capable of eliminating HIV infected cells.

“The treatments were very well-tolerated and CD4+ cell counts did not decrease.”

"Unlike traditional vaccines that prevent disease, therapeutic vaccines are given to people who are already infected to enhance and broaden the body's immune response. Our Phase II trial provides evidence that DermaVir immunizations improve natural immunity against HIV and suppress virus replication. Our goal is to preserve the health of individuals early following HIV infection," said Julianna Lisziewicz, PhD and CEO of Genetic Immunity. "The FDA approved the first therapeutic vaccine, Dendreon's Provenge^®, in April of this year. Dendreon removes a patient's dendritic cells, transports them to a facility where they are "trained" ex vivo to orchestrate an immune response to seek and destroy prostate cancer cells, and then re-infuses them to the patient. Applied to the skin, DermaVir avoids the complexity and cost of the Dendreon approach while accomplishing the same training of the body's dendritic cells in vivo, in this case to seek and destroy HIV-infected cells."

DermaVir, a synthetic plasmid DNA-containing nanomedicine designed to resemble a naturally occurring pathogen, is administered topically with the dendritic cell-targeting DermaPrep medical device. Lymph node dendritic cells then express 15 HIV clade B protein antigens that can self assemble to form HIV virus-like-particles. These HIV antigen presenting dendritic cells prime naïve T cells and expand the HIV-specific T cell pool to kill HIV-infected cells.

In a randomized, placebo-controlled, dose-ranging Phase II study conducted in Hamburg, Germany, thirty-six HIV-infected individuals not yet taking antiretroviral drugs received one of three DermaVir doses or placebo every six weeks. "The treatments were very well-tolerated and CD4⁺ cell counts did not decrease." explained the study's Principle Investigator, Jan van Lunzen, MD of the University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit. "At 24 weeks, the individuals' HIV viral loads were compared to their baseline values. A statistically significant reduction of 0.5 log₁₀ copies/mL - a 70 percent reduction equivalent to that produced by several anti-HIV drugs - was seen in the cohort receiving 0.4 mg DermaVir vaccinations. Also in this group, HIV gag-specific precursor/memory T cells increased by 97 percent as the viral load decreased, a relationship not seen with the presently available drugs. Based upon our study results, the immune boosting and antiviral activity of DermaVir immunizations may provide a unique treatment approach for people with HIV/AIDS."

Genetic Immunity also reports progress in its proprietary technology employing nanotechnology to improve the biological activity of DNA vaccines. "We have optimized the nanomedicine size, compactness and excipients to obtain a stable liquid nanomedicine formulation. This has been a significant challenge in the industry" stated Genetic Immunity's Enikő Tőke, PhD. "The new DermaVir formulation is developed for large scale manufacturing and filling into a needle-free applicator suitable for topical administration with DermaPrep."