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news.Genetic Immunity, a clinical-stage company focused on the development of nanomedicines for targeted immune amplification, has treated the first subject in a Phase II clinical study to evaluate DermaVir patch.
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DermaVir Patch, the company’s nanomedicine candidate for treatment-naive 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 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.
Julianna Lisziewicz, CEO of Genetic Immunity, said: “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.”