VGX Pharmaceuticals (VGX) has announced that the Company has signed a multi-year supply agreement to provide plasmid DNA to support the ongoing toxicology and clinical trials of the United Kingdom Cystic Fibrosis Gene Therapy Consortium comprising over 80 scientists and clinicians in Edinburgh, London and Oxford dedicated to the search for effective gene therapy to the lungs of those with Cystic Fibrosis.
Under the terms of the agreement, VGX will provide multiple batches of a CFTR product to support clinical studies planned to run through 2010. If all options are exercised, several hundred grams of plasmid DNA will be provided, making this agreement one of the largest contracts for non-viral gene therapy products ever undertaken.
Alan Larsen, Director of Research at the Cystic Fibrosis Trust, said, "The CF Trust has committed over £30 million to the Consortium's cutting edge work culminating in a phase II clinical trial planned for 2009, and we are proud to be leading the world in gene therapy research for Cystic Fibrosis.”
Consortium Lead Investigator, Dr. Deborah Gill, said, “We are delighted with our relationship with VGX. Our CpG-free product, utilizing technology developed by Cayla-InvivoGen, presented some unique challenges for large-scale production, but the Team at VGX used their vast expertise in producing non-viral products to meet our demanding timelines. Preliminary results suggest that the materials produced at VGX are of a higher purity than previous batches leading to better overall performance in pre-clinical studies."
Dr. J. Joseph Kim, President and Chief Executive Officer, said, “We are pleased that the UK CF Gene Therapy Consortium has validated our processing technology. The signing of the ongoing supply agreement indicates the confidence the Consortium has in our ability and the scalable nature of our manufacturing process."