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Ed. Note: The following is a press
release from Oxford Biomedica Plc.
OXFORD
BIOMEDICA PRESENTS ENCOURAGING INNUREX(R) PRECLINICAL EFFICACY DATA IN
SPINAL CORD INJURY
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
http://www.oxfordbiomedica.co.uk/.
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.
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