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Polyplus-transfection has produced the first GMP-quality
clinical batch of its nucleic acid transfer agent
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 research 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. Phase I/II cancer gene therapy and AIDS trials are underway
in Israel, USA and Hungary using GMP-grade reagents from Polyplus-transfection.
Polyplus' innovative R&D has well-established partnerships with biotech
companies, and is involved in several European research collaborations 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 one of the technology leaders in the
transfection market with ISO 9001:2000 certification, three exclusive licenses
from the CNRS and numerous patents filed.
For more information, visit:
http://www.polyplus-transfection.com
For further information, please contact:
Andrew Lloyd & Associates
Andrew Lloyd / Neil Hunter
Tel: +44 1273 675100
allo@ala.com
/ neil@ala.com
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