Clinical Trials

DermaVir is our lead product candidate developed for the treatment of HIV/AIDS. The API is a pDNA expressing the broadest HIV antigen repertoires and Virus-like Particles VLP+. The API is formulated to a pathogen-like nanomedicine product and administered topically with our DermaPrep medical device. DermaVir exhibits its specific pharmacologic effects by boosting the patient's own immune system to kill HIV-infected cells. This is a novel immunological Mechanism of Action different from antiretroviral drugs that kill the virus but cannot kill the infected cells.

DermaVir Phase II. results

GIEU006 was designed to evaluate safety of repeated DermaVir immunizations in antiretroviral-naïve subjects and also test the immunogenicity and antiviral efficacy to guide later development.

36 HIV-infected adults (HIV-RNA: 5,000 to 150,000 copies/mL and CD4: =400 cells/mm3) were randomized to receive one of three DermaVir doses (0.2, 0.4 or 0.8 mg of pDNA) or placebo at weeks 0, 6, 12 and 18. Standard parameters and HIV(gag)-specific precursor T cells were quantified through week 24. ITT was analyzed by non-parametric statistical tests, the treatment effect with Hodges-Lehmann estimator.

Baseline characteristics were comparable across groups (median age: 38 years; CD4: 506 cells/mm3; HIV-RNA: 20,250 copies/mL; 83% Caucasian; 97% male). No subject stopped vaccinations due to an AE and only one subject initiated ARV. No AE =Grade3 occurred, grade 1 and 2 incidences were similar across groups, and only one Grade2 AE was possibly-related to the vaccine. Anti-dsDNA decreased, ANA and CD4 counts did not change and HIV-RNA did not increase. Based on secondary analyses, the 0.4 mg group was superior to others. In this group the HIVgag-specific precursor T cells increased from 5,055 to 9,978 cells/millionPBMC (P=0.07). The median log10 HIV-RNA decreased from 4.5 to 4.0, significantly different from the placebo (P=0.045). The treatment effect compared to placebo at 95% confidence interval was -0.23 (-0.70; 0.09) for log10 HIV-RNA.

DermaVir did not increase viral load nor reduced CD4 counts and was as safe as placebo. Its antiviral and immune-boosting effects in the challenging antiretroviral-naïve setting support further development. The 0.4 mg dose emerged as the vaccine candidate for the early treatment of HIV infection.

Clinical Trials Involving DermaVir, 2011: