Oxford BioMedica presents manufacturing process for gene therapy, ProSavin during BIO 2003

Oxford, UK: 23 June 2003. Oxford BioMedica announced today the details of its novel manufacturing process for ProSavinâ, for the treatment of Parkinson’s disease, that will be presented at the BIO 2003 Annual Convention in Washington DC on 25 June. The new manufacturing process has the capacity to satisfy all of the Company’s requirements up to Phase II clinical trials and the team is currently working on a refinement of the process to scale-up for Phase III trials and commercial production.This will be the first time that Oxford BioMedica has disclosed details of its novel production approach for LentiVector®-based products. LentiVector is able to deliver genes to non-dividing cells, such as brain cells, and ProSavin delivers the genes for dopamine synthesis directly to the striatum of the brain, thereby creating endogenous production of dopamine, the neurotransmitter that is lost in Parkinson’s patients. The target market is late stage disease where ProSavin could offer significant advantages over existing therapy. 

Dr Carlos Ibanez, Director of Process and Product Development at Oxford BioMedica’s US subsidiary BioMedica Inc., will give a presentation during a panel discussion on innovative manufacturing strategies for viral and non-viral gene based therapies. The establishment of effective manufacturing processes represents a key milestone on the path to the IND submission that is planned for ProSavin later in 2003 following the completion of preclinical efficacy and toxicity studies. Phase I trials are planned for 2004. 

Commenting on the development Dr Doug Jolly, CEO of BioMedica Inc., said, “We are delighted to have brought the LentiVector production system successfully from laboratory bench to manufacturing for clinical trials. The process has been developed following constructive dialogue with the FDA and UK regulatory authorities and through close collaboration with the technical team in Oxford. Gene therapy has been limited in the past by production problems. This will not be the case for Oxford BioMedica’s products.” 

During the past 18 months the technical team at BioMedica Inc has been developing a cost effective, GMP-compatible manufacturing process that can be used for ProSavin and all of the Company’s other LentiVector®-based products. The vector production process is at the 40 litre scale by transient transfection. The clinical trial material is processed by chromatographic methods and packaged in single use glass vials containing 100-200 μl of product. This yields 2-5 ml of high titre product (>109 TU/ml), which is sufficient for 15-40 human dose equivalents. It can be transported and stored at –70oC with an expected shelf life in excess of 12 months. 

The obvious regulatory issues for a novel gene therapy such as appropriate safety and product release assays, including those for replication-competent virus, have been discussed with the FDA. Based on these discussions, relevant assays have been developed. 

Ends- 

Notes to Editors 
1. Oxford BioMedica 
Established in 1995 as a spin out from Oxford University, Oxford BioMedica plc specialises in the development of novel gene-based therapeutics for the treatment of cancer, neuro-degenerative disease and other disorders with major unmet clinical needs. The development pipeline includes two novel anti-cancer products in clinical trials and a gene therapy treatment for Parkinson’s disease, which is in late preclinical studies. This is underpinned by a broad research pipeline and over 70 patent families, about quarter of which are issued.  

Oxford BioMedica’s products use genes as the mediators of a therapeutic effect and/or immune response. The Company’s gene therapy products deliver therapeutic molecules in vivo whilst its gene-based immunotherapy products deliver genes that recruit the patient’s immune system to mediate a therapeutic effect. The genes are delivered by the Company’s highly engineered viruses or cells. 

BioMedica’s lead product TroVax® is an anti-cancer therapeutic vaccine expected to be useful against a broad range of tumour types. It is entering Phase II trials in a number of indications including colorectal and renal cancer, and is expected to be ready for Phase III trials at the end of 2003. The Company’s second cancer product, MetXia®, is completing Phase I/II studies in breast cancer. 

Oxford BioMedica is headquartered in Oxford, UK and has a wholly-owned subsidiary in San Diego, USA. BioMedica has corporate collaborations with Wyeth, IDM, Intervet, Aliga Pharmaceuticals, Amersham, Arius Research and Viragen.  

Oxford BioMedica plc was floated on the Alternative Investment Market of the London Stock Exchange in December 1996, and was promoted to the United Kingdom Listing Authority Official List in April 2001 following a successful £35.5 million fund-raising.  

Further information is available at http://www.oxfordbiomedica.co.uk  

2. ProSavinâ and the LentiVector® technology 
ProSavin is Oxford BioMedica’s most advanced programme that uses the proprietary LentiVector® gene delivery system.  

Oxford BioMedica’s LentiVector gene delivery technology is arguably the most potent system currently available for treating diseases of the central nervous system, particularly chronic neurodegenerative disorders. LentiVector is a new gene delivery vector that is based on lentiviruses. The system contains only the few viral components that are required for efficient gene delivery. Oxford BioMedica has shown that minimal lentiviral vectors are able to deliver genes to a wide range of dividing and non-dividing cells, including neurones in the brain. Oxford BioMedica has granted and pending patents on the technology which provide a sound basis for freedom to operate in this field. 
This technology forms the delivery system for several of the Company’s products that are approaching the clinical development stage. In addition to ProSavin, there are three further research/preclinical stage programmes using the LentiVector system: RetinoStatÔ, for retinopathy (vision loss), InnurexÔ, for nerve repair in spinal cord injury, and MoNuDinÔ, for motor neuron disease. 

For immediate release: 7am BST, 23 June 2003		2003/OB/11
For further information, please contact:
Oxford BioMedica plc
Professor Alan Kingsman, Chief Executive	Tel: +44 (0)1865 783 000
City/Financial Enquiries: Mike Wort, James Chandler: Beattie Financial	Tel: +44 (0)20 7398 3300
Scientific/Trade Press Enquiries: Sue Charles, Katja Stout: Northbank Communications	Tel: +44 (0)20 7886 8150