BioWorld International Correspondent

PARIS - Polyplus-transfection produced the first clinical batch of its transfection reagent in vivo-jetPEI, manufactured in full compliance with good manufacturing practice (GMP).

The company pointed out that GMP compliance in vivo-jetPEI is required for clinical trials involving the delivery of nucleic acids (DNA and siRNA) and that the agent is due to be used in a Phase II clinical trial in a cancer indication later this year.

Polyplus-transfection, of Strasbourg, France, is specialized in the development and marketing of reagents for RNA interference (RNAi) and transfection. It is developing several in vivo siRNA formulations based on two lead compounds, the main one being in vivo-jetPEI, which allows intracellular delivery of nucleic acids. The compound is derived from the synthetic molecule polyethylenimine (PEI), for which Polyplus-transfection holds an exclusive worldwide license for the transfection of nucleic acids.

Polyplus-transfection's technology allows its customers to use the same transfection reagent from the early stages of preclinical research to clinical trials in humans. The company said in vivo-jetPEI molecule is able to transfect effectively both in vitro and in vivo, which is not the case with most transfection reagents on the market.

The development of the in vivo-jetPEI GMP-compliant process required the design of new quality-control tests to meet current requirements in the U.S. and the European Union. A Drug Master File describing the manufacturing of in vivo-jetPEI has been filed with the FDA.