Preclinical Data Shows Promise For New Drug In Repairing Nerves

Ed. Note: The following is a press release from Oxford Biomedica Plc.


Oxford, UK: 3 June 2005 - Oxford BioMedica (LSE: OXB), the leading gene therapy company, is today presenting encouraging Innurex preclinical efficacy data at the Annual Meeting of the American Society of Gene Therapy (ASGT) in St. Louis, Missouri, USA. The data show, for the first time, that Innurex, Oxford BioMedica's gene-based product for nerve regeneration, is able to induce nerve repair in spinal cord (corticospinal tract) injuries and restore both sensory and motor functions in a placebo controlled preclinical model. Very few products have been able to show nerve repair in models of spinal cord injury and no products to date have achieved this in the clinical setting.

In this preclinical study of spinal cord injury, Innurex stimulated cellular repair in the form of nerve regrowth across the injury. Functional repair was assessed by measuring time taken or movement during certain tasks, such as ladder crossing and grid walking. Following Innurex treatment, there was a statistically significant improvement in functional ability compared to placebo on most measures. These new data add to previous observations in preclinical models of avulsion (stretch) injury and suggest that Innurex may be useful in the clinical treatment of both stretch injury and the technically more challenging spinal cord damage.

Commenting on the Innurex data, Oxford BioMedica's CEO, Professor Alan Kingsman, said: "These new results substantially strengthen the preclinical data set for Innurex. We are now working towards an assessment of how to move Innurex into initial Phase I/II clinical trials so that this innovative product can be evaluated for the treatment of patients with these devastating injuries as quickly as possible."

Innurex delivers the RAR2 gene to damaged nerve cells using the Company's proprietary LentiVector® gene delivery technology. The gene causes nerve cells to 'sprout' new nerve fibres that have the potential to remake connections that may restore both sensation and movement to afflicted limbs.

The preclinical evaluation of Innurex and today's ASGT presentation are part of an ongoing collaboration with scientists at King's College London, who received a grant from the Christopher Reeve Paralysis Foundation to pursue the study of Innurex in spinal cord injury. Details of the ASGT presentation are as follows:

"Lentiviral vector expressing retinoic acid receptor 2 promotes regeneration in a rat spinal cord injury model" (Abstract #648)

Session title: Neurologic - Spinal Cord Injury and Motor Neuron Disease

Friday, 3 June, 4:00pm to 7:30pm, Exhibit Hall 2, America's Center, St. Louis, Missouri

About Oxford BioMedica

Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in the development of novel gene-based therapeutics with a focus on the areas of oncology and neurotherapy. The Company was established in 1995 as a spin out from Oxford University, and is listed on the London Stock Exchange.

Oxford BioMedica has core expertise in gene delivery, as well as in-house clinical, regulatory and manufacturing know-how. In oncology, the pipeline includes an immunotherapy and a gene therapy in multiple Phase II trials, and a preclinical targeted antibody therapy in collaboration with Wyeth. In neurotherapy, the Company's lead product is a gene therapy for Parkinson's disease, which is expected to enter clinical trials in early 2006, and four further preclinical candidates. The Company is underpinned by over 80 patent families, which represent one of the broadest patent estates in the field.

The Company has a staff of approximately 65 split between its main facilities in Oxford and its wholly owned subsidiary, BioMedica Inc, in San Diego, California. Oxford BioMedica has corporate collaborations with Wyeth, Intervet, Amersham, Viragen, MolMed and Kiadis; and has licensed technology to a number of companies including Merck & Co and Biogen Idec.

Further information is available at

About Innurex(R) and Nerve Repair

Innurex is Oxford BioMedica's gene-based product for nerve regeneration for the treatment of spinal cord and related injuries. Based on the LentiVector technology, the product carries the gene for a subtype of the retinoic acid receptor (RAR2) that induces nerve cells to regrow by a process known as 'sprouting'.

Within the field of neurobiology nerve repair has been a long sought goal for the treatment of nerve damage and spinal injury. The objective is to develop treatments that induce nerve cells to regrow and bridge sites of injury, thereby reconnecting the nerve fibres and restoring function. Spinal cord and nerve injuries affect approximately 20,000 people per year in Europe and the United States. There are no effective products to treat these debilitating conditions and prognosis for functional recovery is generally poor. Innurex seeks to address this unmet medical need that could represent a market of up to US$2 billion.

During 2004, Oxford BioMedica reported that Innurex restores function to damaged limbs in a preclinical model of avulsion or stretch injury. These results indicate that Innurex may benefit patients with nerve damage resulting from severe pull or stretch injury, a common consequence of sporting and motor accidents. Today's presentation at ASGT shows that Innurex may repair nerve damage in spinal cord injuries. Further preclinical studies and clinical planning are underway.

The company's collaborator on Innurex, King's College London, was awarded a grant of US$150,000 for the programme in April 2004 from the Christopher Reeve Paralysis Foundation. This grant supports studies to explore the use of Innurex in spinal cord injury.

About ASGT

The American Society of Gene Therapy (ASGT) is a professional non-profit medical and scientific organisation dedicated to the understanding, development and application of gene and related cell and nucleic acid therapies and the promotion of professional and public education in the field. ASGT is the largest medical professional organisation representing researchers and scientists dedicated to discovering new gene therapies.