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2005/OB/25
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OXFORD
BIOMEDICA SUCCESSFULLY COMPLETES STAGE ONE OF THE PHASE II
TRIAL WITH METXIA® IN PANCREATIC CANCER
Oxford
BioMedica (LSE: OXB), the leading gene therapy company, announced
today that the first stage of its Phase II trial in pancreatic
cancer with MetXia, the Company's gene targeted prodrug
activation product, has been successfully completed. The objectives
were to assess the safety of administering MetXia locally
to the pancreatic tumour, to confirm gene transfer at the
tumour site following local delivery and to identify an optimal
dose for the second stage of the trial.
The two-stage Phase
II trial is designed to evaluate MetXia and the chemotherapy
prodrug cyclosphosphamide (CPA) in patients undergoing palliative
surgery for pancreatic cancer. The trial is being conducted
at the Royal Liverpool University Hospital. In the first stage
of the trial, two dose levels of MetXia were assessed in six
patients in combination with a low dose of CPA. Each patient
had two administrations of MetXia, prior and subsequent to
surgery, followed by CPA. Both dose levels of MetXia were
safe and well tolerated. Importantly, dose dependent expression
of the specific human cytochrome P450 gene, delivered by MetXia,
was observed in tumour biopsies taken at surgery.
MetXia comprises
a highly engineered retrovirus that delivers the P450 gene
to tumour cells. The enzyme encoded by the P450 gene activates
CPA to a form that destroys cells. With conventional oral
and intravenous administration of CPA, the drug is activated
in the liver by the P450 enzyme. This trial utilises catheter-enabled
local delivery of both MetXia and CPA to the pancreas, thereby
focusing gene delivery and activation of CPA in the target
tissue. This minimises the side effects of liver toxicity
and systemic dispersal of activated CPA that are associated
with oral administration of CPA. The route of administration
represents a novel and potentially highly potent strategy
for optimising chemotherapy at the tumour site.
Following the encouraging
results in stage one of the trial, patient recruitment is
commencing for the second stage with a fixed dose of MetXia
and increasing doses of CPA. Stage two will accrue up to 25
patients and will determine the optimal dose of CPA. This
second stage of the trial is designed to evaluate clinical
benefit as well as safety. An additional clinical trial site
in London is expected to open for part two of the trial, which
will boost patient accrual. Preliminary efficacy data is expected
in early 2006.
Commenting on the
MetXia results, Oxford BioMedica's Chief Executive,
Professor Alan Kingsman said: "It is very encouraging
that MetXia has achieved its endpoints of safety and gene
transfer with this novel route of delivery. We look forward
to evaluating clinical benefit in the next stage of the trial.
There is a clear unmet need for effective therapies for pancreatic
cancer, which MetXia has the potential to address."
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Notes
| 1. |
Oxford
BioMedica |
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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
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, Viragen, MolMed and Kiadis; and
has licensed technology to a number of companies
including Merck & Co, Biogen Idec and
Pfizer. |
| 2. |
MetXia®
and Pancreatic Cancer |
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MetXia is Oxford BioMedica’s lead
gene-based cancer therapeutic. The product
comprises a highly engineered retrovirus
that delivers a specific human cytochrome
P450 gene to tumour cells. The enzyme encoded
by the P450 gene activates the commonly
used cancer chemotherapy drug, cyclophosphamide
(CPA), to a form that destroys cells. MetXia
converts the tumour into a ‘drug factory’,
enabling local production of the anti-tumour,
cytotoxic derivative of CPA. MetXia is potentially
useful in the treatment of all solid tumours
and their metastases, particularly those
where cyclophosphamide has proven efficacy.
The
initial indication for the development of
MetXia is the treatment of pancreatic cancer
through direct administration of both MetXia
and CPA to the tumour. Published data from
trials with locally administered CPA and
encapsulated cells carrying the P450 enzyme
have validated the concept of treating pancreatic
cancer with this approach. MetXia uses Oxford
BioMedica’s gene therapy technology
to deliver the P450 gene efficiently to
pancreatic tumour cells.
Pancreatic
cancer is the fifth leading cause of cancer-related
mortality in the United States with over
30,000 deaths attributable to this disease
annually. Survival time is generally less
than one year. Treatment options are limited,
although chemotherapy is the mainstay for
locally advanced, unresectable tumours.
Since cancer of the pancreas has the shortest
median survival time of all cancer types,
there is a critical unmet need for novel,
safe and effective treatments. |
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further information please contact:
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Oxford BioMedica plc
Professor Alan
Kingsman, Chief Executive |
Tel: +44 (0)1865 783 000 |
| City/Financial
Enquiries
Lisa
Baderoon/Mark
Court/Mary-Jane
Johnson
Buchanan Communications |
Tel: +44 (0)20 7466 5000
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Scientific/Trade
Press Enquiries
Sue
Charles, Katja
Stout, Ashley
Lilly
College Hill - Life Sciences |
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+44 (0)20 7886 8150 |
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