Jun 11 2009
Genetic Immunity, a US/Hungarian biopharmaceutical company establishing leadership in Nanomedicines for immune amplification, is pleased to announce completion of patient enrollment in the Company's Phase II randomized, placebo-controlled, multi-center study to evaluate the safety, tolerability, immunogenicity, and antiretroviral activity of DermaVir Patch in treatment-naïve HIV-1-infected patients. The study is conducted in Hamburg, Germany with a total of thirty-six patients.
"We are very happy with completion of patient enrollment in this seminal trial because it allows us to conclude the immunization schedule in this year. This trial has a unique design to investigate DermaVir Patch as mono-immunotherapy in HIV-infected individuals who are not treated with antiretroviral drugs. We are very excited to learn how our immune therapeutic nanomedicine affects the immune system and disease of this patient population. With this trial we plan to demonstrate the safety and efficacy of DermaVir Patch as monotherapy administered every 6 weeks for the treatment of HIV," commented Julianna Lisziewicz, CEO of Genetic Immunity.
This novel plasmid DNA-based nanomedicine vaccine candidate, DermaVir Patch, has been under development in the last ten years. Phase I trial showed preliminary safety and tolerability and induction of memory T-cell immunity in all HIV-1-infected individuals. DermaVir is based on a single plasmid DNA capable to express most HIV antigens and to form a virus-like particle (VLP+). Plasmid DNA is formulated with a polymer to mimic a pathogen. DermaVir enters into the body via the Langerhans cells of the skin and induces memory immune responses in the lymph nodes.
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 6 arms: Arm 1 patients will receive low dose DermaVir patch (0.2 mg DNA, n=9); Arm 2 patients will receive low dose placebo patch (n=3); Arm 3 patients will receive medium dose DermaVir patch (0.4 mg DNA, n=9); Arm 4 patients will receive medium dose placebo patch (n=3); Arm 5 patients will receive high dose DermaVir patch (0.8 mg DNA, n=9); Arm 6 patients will receive high dose placebo patch (n=3).
Immunization will be done on days 0, 42, 84, and 126. The total number of patches that a patient will receive throughout the study will be 8, 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 3 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.