Genetic Immunity, a US/Hungarian clinical-stage company focused on development of nanomedicines for targeted immune amplification, today announced it has treated the first subject in a Phase II clinical study to evaluate DermaVir Patch.
DermaVir Patch, the Company's lead nanomedicine candidate for treatment-naïve HIV-infected individuals, is designed to amplify de novo HIV-specific memory T-cell responses of HIV-infected individuals and improve the ability of their own immune system to control the disease.
The placebo controlled, multicenter, Phase II study (GIEU006) is designed to evaluate safety, immunogenicity and antiviral activity while establishing a safe, well-tolerated dosing regimen for DermaVir Patch. The trial is being conducted in HIV-infected individuals not yet eligible for antiretroviral drug treatment according to present guidelines.
Previous studies demonstrated that DermaVir Patch differs from traditional therapies in safety, mechanism of action and dosing. A Phase I/II trial has shown DermaVir Patch induces long-lasting HIV-specific memory T-cells that play an important role in controlling viral load and disease progression. DermaVir Patch toxicities have been limited to mild, reversible local skin reactions. The needle-free, topically-applied DermaVir Patch could be administered nine times per year or less, contrasting sharply with traditional antiretroviral drugs that require continuous daily dosing.
Principal investigator Jan van Lunzen, MD of the University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit said, "Our clinical team is excited to participate in research therapies that can feasibly offer clinical benefit to HIV patients around the world. An early stage immune therapy that can slow disease progression would provide a significant public health benefit and encourage more people to pursue AIDS testing and enter treatment. Therefore, we are excited to observe the outcome of DermaVir Patch administration on HIV-infected patients who are not yet sick enough to receive antiretroviral drugs."
Julianna Lisziewicz, PhD, CEO of Genetic Immunity, said, "Each trial is an important step toward marketing approval and our ability to help people living with HIV. We are excited to bring DermaVir Patch to Phase II and are optimistic that it might be possible to prolong patients' time before requiring antiretroviral therapy. In previous trials, this nanomedicine candidate has demonstrated amplification of the immune system and the reconstitution of HIV-specific T-cell precursors that expand to kill HIV-infected cells. This novel mechanism of action makes DermaVir Patch attractive for early-stage HIV-infected individuals who are not yet eligible for traditional antiretroviral therapy."
GIEU006 is a Phase II, randomized, placebo-controlled, multi-center study being conducted in Germany to evaluate DermaVir Patch in 36 treatment-naïve HIV-1-infected patients. The primary objectives are to evaluate safety and tolerability while establishing a safe and well-tolerated dosing regimen. Secondary objectives assess DermaVir Patch's antiretroviral activity via HIV-1 RNA measurements and immunogenicity as well as changes in CD4+ and CD8+ T-cell counts during treatment.
Patients will be randomized to six treatment arms to receive one of three doses of DermaVir (two, four or eight patches with 0.1 mg DNA per patch) or equivalent placebo patches. The total group of 36 patients will consist of nine in each treatment dosing group and three in each placebo group.
Subjects will be immunized every six weeks over an 18-week period with assessment of primary endpoints at Week 24. After Week 24, subjects will be followed for additional safety and immunogenicity evaluations through Week 48, after which safety follow-up will be performed every 26 weeks for an additional 234 weeks.
Genetic Immunity's nanomedicine immune amplification platform technology is comprised of two principal components: NanoComp and DermaPrep. NanoComp is a patented nanoformulation technology that includes disease-specific plasmid DNA encoded antigens. DermaPrep is the topical administration device that delivers NanoComp to lymph node dendritic cells to induce targeted T-cell-mediated immune responses. These two components, together with the Company's proprietary plasmid DNA, make up the DermaVir Patch. The plasmid DNA within the NanoComp nanoparticles is HIV-specific and topically delivered via DermaPrep to amplify the immune system to kill only HIV-infected cells.