Genetic Immunity has successfullty developed a stable, liquid formulation of a topically-administered nanomedicine vaccine for the treatment of HIV/AIDS. With results reported in the International Journal of Pharmaceutics, the company's DermaVir product is entering Phase II/III human trials.
"One challenge in clinical nanomedicine development is to produce a stable formulation with reproducible manufacturing methods," explains Genetic Immunity's Enikõ Tõke in a statement. "We found several additional quality requirements of the components that were essential both to establish the optimal relationship between physicochemical properties and biological activity of DermaVir and to ensure reproducible manufacturing of a stable formulation. It became apparent that the current state-of-the-art approaches to sourcing, testing and manufacturing were insufficient."
To deal with the problem, Genetic Immunity developed a new formulation of pDNA surrounded by a chemical polymer capable of maintaining the physical stability and biological activity of DermaVir at 4oC.
Genetic Immunity CEO Julianna Lisziewicz says the company believes DermaVir will become the first nanomedicine vaccine developed to reconstitute HIV-specific immunity with the potential to maintain the health of people living with the disease.
- here's the Genetic Immunity release