VGX Pharmaceuticals Signs Multi-Year Production Agreement With the United Kingdom Cystic Fibrosis Gene Therapy Consortium
Posted on: Monday, 12 May 2008, 09:01 CDT
VGX Pharmaceuticals (VGX) today 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."
About VGX Pharmaceuticals
VGX Pharmaceuticals is a biopharmaceutical company with small molecule and biologic product candidates for the treatment of infectious diseases, cancer, and inflammatory diseases. The Company's clinical development programs include PICTOVIR™ for HIV infection, which is in Phase II clinical trials, PENNVAX™-B for HIV infection, which is in 2 separate Phase I clinical trials, and VGX-1027 for inflammatory diseases, which is in Phase I clinical trials. In addition, The Company has filed an IND for VGX-3200, a novel DNA therapy that utilizes GHRH for the treatment of cancer cachexia and anemia. VGX has established a vertically-integrated DNA Vaccines and Therapies Platform with extensive capabilities including SynCon™ DNA-based product candidates, the patented CELLECTRA® delivery device, and efficient cGMP plasmid manufacturing facilities. The cGMP facilities are used for VGX's own product supplies and for contract manufacturing. Vertical control over key aspects of product development has enabled the Company to consistently develop multiple product candidates, from bench-to-IND filing, within 1 year. The product candidates and technology programs are protected by the Company's extensive global intellectual property portfolio. More information about VGX can be found at www.vgxp.com.
About Cystic Fibrosis Trust
The Cystic Fibrosis Trust (www.cftrust.org.uk) is the UK's only national charity dealing with all aspects of Cystic Fibrosis (CF). It funds research to treat and cure CF and aims to ensure appropriate clinical care and support for people with Cystic Fibrosis. For further information on the work of the UK CF Gene Therapy Consortium, please visit www.cfgenetherapy.org.uk.
About Cayla-InvivoGen
Cayla-InvivoGen (www.invivogen.com) is a biotechnology company developing innovative products based on breakthroughs in molecular and cell biology. The company clinical development program includes a phase I non-viral clinical trial in pancreatic cancer (www.invivogen-therapeutics.com). The new family of plasmids used for this clinical trial is completely devoid of CpG dinucleotides and has been developed for non-viral gene therapy application. These CpG-free plasmids are non-immunostimulatory even at high doses and allow for sustained expression. This technology and its use are covered under US patent number 7244609 and are distributed for research purposes by InvivoGen.
Source: Business Wire
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