Power of the Dream Ventures, a Hungarian technology acquisition and development company, has reported that Genetic Immunity, a US/Hungarian biopharmaceutical company, has completed patient enrollment in its Phase II randomized, placebo-controlled, multi-center study to evaluate the safety, tolerability, immunogenicity, and antiretroviral activity of DermaVir patch in treatment-naive HIV-1-infected patients.

The study is conducted in Hamburg, Germany with a total of 36 patients. The primary outcome of this Phase II study measures safety and tolerability of DermaVir patch, while secondary outcome includes HIV-1 RNA measurements to assess the antiretroviral activity of the DermaVir patch, changes in CD4+, CD8+ T-cell counts and HIV-specific immunogenicity during DermaVir patch treatment.

The study randomized patients into one of six arms: arm one patients will receive low dose DermaVir patch (0.2mg DNA, n=9); arm two patients will receive low dose placebo patch (n=3); arm three patients will receive medium dose DermaVir patch (0.4mg DNA, n=9); arm four patients will receive medium dose placebo patch (n=3); arm five patients will receive high dose DermaVir patch (0.8mg DNA, n=9); arm six patients will receive high dose placebo patch (n=3).

Immunization will be done on days zero, 42, 84, and 126. The total number of patches that a patient will receive throughout the study will be eight, 16, or 32 in the low, medium, and high dose arms, respectively. The patch sites for immunization are preferably the left or right upper back and left or right upper ventral thighs. The same skin sites might be used for all patch immunizations that last for three hours.

Patients will be on-study for 282 weeks. The immunizations will be administered over an 18-week period with an identical follow up schedule continuing until week 24; patients will be followed for an additional 24 weeks for additional safety and immunogenicity evaluations. An additional 234 weeks safety follow-up will be performed including chemistry and hematology assessments and physical examinations.

Julianna Lisziewicz, CEO of Genetic Immunity, said: "We are very happy with completion of patient enrollment in this seminal trial because it allows us to conclude the immunization schedule in 2009. With this trial we plan to demonstrate the safety and efficacy of DermaVir patch as monotherapy administered every six weeks for the treatment of HIV."

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