Oxford, UK: 13 November 2003 – Oxford BioMedica announced today that it is presenting the first preclinical data from its motor neuron disease programme at two consecutive conferences: the 11th Congress of the European Society on Human Gene Transfer and Therapy held in Edinburgh, UK, on 13-17 November; and the 14th International Symposium on Amyotrophic Lateral Sclerosis and Motor Neuron Disease held in Milan, Italy, on 17-19 November 2003.  Drs. Nick Mazarakis and Mimoun Azzouz, from the Company’s neurobiology group, will present data showing that the MoNuDin^TM programme has achieved a major technical milestone.  In an industry standard animal model of motor neuron disease, treatment with MoNuDin resulted in significant motor (movement) improvement, a substantial delay in the onset of disease and increased survival time.

 

MoNuDin comprises a neuroprotective gene delivered by the Company’s proprietary LentiVector system.  The product is designed to be injected into muscle, but mediates its therapeutic effect within the nerve cells of the spine.  There is currently no known cure for motor neuron disease, a condition that affects approximately 100,000 people in Europe and the US.  Oxford BioMedica’s novel programme is supported by the largest US charitable organisation for this condition, the Amyotrophic Lateral Sclerosis (ALS) Association. The ground breaking technology employed in MoNuDin is also used in the Company’s spinal muscular atrophy (SMA) programme. The Company estimates that, if successful, these two products could reach markets in excess of $300 million per annum.

 

Commenting on the presentations , Oxford BioMedica’s Chief Executive, Prof. Alan Kingsman said, “The Company’s neurobiology programme goes from strength to strength. These new data pave the way for MoNuDin to enter clinical development on schedule and, in addition, they bode well for the SMA programme.”

 

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Notes to editors:

 

1. Oxford BioMedica

Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in the development of gene-based products for a range of unmet medical needs with an emphasis on new cancer products, which combine novel mechanisms of action with very low side effects, and innovative neurotherapy products, which address large and, in several areas, untapped markets. The products are all protected by multiple patents comprising a total intellectual property portfolio of approximately 70 patent families.

 

In addition to its technical research skill-base, Oxford BioMedica has in-house clinical, regulatory and manufacturing know-how. The development pipeline includes two novel anti-cancer products in clinical trials and a gene-based treatment for Parkinson’s disease, which is in late preclinical studies.

 

TroVax®, Oxford BioMedica’s lead cancer immunotherapy product, is in Phase II trials for colorectal cancer. Further Phase II trials are planned for breast and renal cancer. MetXia®, Oxford BioMedica’s lead gene-based cancer therapeutic, is based on a highly engineered retrovirus gene delivery system expressing a specific human cytochrome P450 gene. MetXia is being investigated in a Phase I/II trial in breast cancer, and is scheduled to start further clinical trials in pancreatic cancer.

 

Oxford BioMedica has a wholly owned subsidiary in San Diego, USA. Oxford BioMedica has corporate collaborations with Wyeth, Intervet, Kiadis, Amersham, Arius Research and Viragen.

 

Further information is available at www.oxfordbiomedica.co.uk  

 

2. MoNuDin™ and Motor Neuron Disease   

MoNuDin comprises a neuroprotective gene delivered by the Company’s proprietary LentiVector system. The product is designed to be injected into muscle, where it enters motor neurons via the neuromuscular junctions. It then travels along the nerves to the spinal cord by a process known as retrograde transport and then mediates its therapeutic effect within the body of the nerve cells in the spine.

 

Motor Neuron Disease (MND) is the name given to a group of related diseases affecting the motor neurons in the brain and spinal cord. Motor neurons are the nerve cells along which the brain sends instructions, in the form of electrical impulses, to the muscles. Degeneration of the motor neurons leads to weakness and wasting of muscles. This generally occurs in arms or legs initially, some groups of muscles being affected more than others. MND is generally a steadily progressive disease, but the rate of progression varies greatly from one person to another.

 

MND can affect any adult at any age but most people who have MND are over the age of 40 and the highest incidence is in the 50-70 age range. Men are affected slightly more often than women.

 

The precise figures for the incidence and prevalence of MND are still uncertain. In the US, more than 5,600 people are diagnosed with MND each year. As many as 30,000 Americans may currently be affected by MND and the average life expectancy of a patient is two to five years from time of diagnosis. The estimated number of people with MND in the UK is up to 5,000.

 

3. The US ALS Association  

Amyotrophic Lateral Sclerosis or Lou Gehrig’s disease (Lou Gehrig was a Yankee Hall of Famer who died of ALS in 1939) is the most prevalent form of motor neuron disease. The ALS Association in the US is the largest private source of funding for ALS-specific scientific research in the world, seeking to identify the cause, means of prevention, and cure for ALS. The ALS Association has some 82 active scientific research projects in its portfolio representing a total commitment of $12 million.

 

Further information on the ALS Association is available at www.alsa.org