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."