| Polyplus-transfection will deliver GMP-compliant in vivo-jetPEI for a Phase II clinical trial Strasbourg, February 1st 2008 — Polyplus-transfection, a company specialized in the research, development and marketing of innovative reagents for transfection and RNA interference (RNAi), announces today the production of the first batch of its transfection reagent in vivo-jetPEI manufactured in full compliance with Good Manufacturing Practice (GMP). This GMP-compliant in vivo-jetPEI is required for clinical trials involving nucleic acids delivery (DNA and siRNA). |   |
Polyplus-transfection carried out preliminary work to transfer production to GMP-compliance in 2007 thanks to financial support from the AFM, France's Muscular Dystrophy Association. This has made it possible for a Phase II clinical trial to start in the field of cancer therapy this year using Polyplus' GMP-compliant in vivo-jetPEI. Details of the clinical trial have not yet been disclosed.
Polyplus-transfection offers its customers the possibility of using the same transfection reagent from the early stages of preclinical research to clinical trials in humans. The in vivo-jetPEI molecule is able to transfect effectively both in vitro and in vivo — which is not the case with most of the commercially available transfection reagents.
A Drug Master File (DMF) describing the manufacturing of in vivo-jetPEI has been filed with the United States Food and Drug Administration (FDA). The DMF provides confidential detailed information about the manufacturing process of the reagent, thus simplifying the FDA documentation required for clinical trial applications. "We are proud to have delivered this first GMP-compliant batch of in vivo-jetPEI and to have completed the production process transfer," said Joëlle Bloch, CEO of Polyplus-transfection. "The GMP-compliant availability of our leading product for human clinical use is a crucial advantage in the choice of a transfection agent for therapeutic projects. It will speed up the growth of all Polyplus' in vivo transfection agents." And she added: "We are eagerly awaiting the beginning of this Phase II clinical trial using in vivo-jetPEI that is scheduled for 2008 in the field of anti-cancer therapy."
The development of the in vivo-jetPEI GMP-compliant process has required the design of new quality control tests to meet the current requirements in the US and the EU.
About Polyplus-transfection
Polyplus-transfection is focused on developing innovative solutions for intracellular delivery of nucleic acids. The company has been marketing its transfection reagents worldwide since 2001 and is reinvesting most of its revenues into research and development. Transfection consists in introducing a gene or a small interfering RNA into cells. This technique makes it possible to cross the cellular barriers and deliver such biomolecules into the cell for research or therapeutic purposes.
Customers of Polyplus-transfection's products and services include biotechnology and pharmaceutical companies as well as life science academic laboratories. Polyplus-transfection offers high quality consultancy, personalized scientific support and expertise in regulatory affairs related to the use of its reagents in clinical trials. Phases I/II cancer gene therapy and AIDS trials are underway in Israel, USA, Sweden and Germany using GMP-compliant reagents from Polyplus-transfection.
Polyplus-transfection R&D has well-established partnerships with biotech companies and is also involved in several European research collaboration networks, such as GIANT (Gene Therapy, an Integrated Approach to Neoplastic Treatment) and RIGHT (RNA Interference Technology as Human Therapeutic Tool). The company also drives the OligoPlus research program for the "Therapeutic Innovations" Competitiveness Cluster, focusing on new tools for diagnostic.
The Strasbourg-based company is recognized as a leading innovator in the transfection market, with ISO 9001:2000 certification, three exclusive licenses from the CNRS and numerous patent filed.
For more information, visit: http://www.polyplus-transfection.com
Source: Polyplus-transfection
