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2005/OB/40
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OXFORD BIOMEDICA
COMMENCES SECOND PHASE II TRIAL WITH TROVAX®
IN RENAL CELL CARCINOMA
Oxford
BioMedica (LSE: OXB), a gene therapy company, announced
today that the first patient has been treated in a second
Phase II trial with TroVax in combination with interleukin-2
(IL-2) in patients with metastatic renal cell carcinoma
(RCC). There are now five Phase II trials ongoing with
TroVax in RCC and colorectal cancer.
The first patient was treated in a second Phase II trial
in RCC at the Methodist Hospital in Texas, US, on 14 November
2005. This open label trial is expected to recruit up to
25 patients. The Principal Investigator for the trial is
Dr Robert Amato, who is an internationally recognised opinion
leader in the treatment of RCC. The trial is designed to
evaluate the safety and immunogenicity of TroVax in conjunction
with low dose IL-2, which is commonly used in the treatment
of RCC. Initial data from this trial are expected in the
first half of 2006.
The Company is targeting RCC as a lead indication for the
development of TroVax, in addition to colorectal cancer.
As reported on 2 November 2005, the Company believes that
RCC is an indication where TroVax might achieve a rapid route
to product registration. The Company aims to initiate a Phase
III trial of TroVax in RCC in 2006 and is targeting product
registration in 2009. In parallel, the Company is conducting
negotiations with potential partners for TroVax. The current
treatment market for RCC is approximately US$600 million
according to Datamonitor.
Commenting on the news, Oxford BioMedica's Chief Medical
Officer, Dr Mike McDonald, said: "We are delighted
to have Dr Amato's support for the TroVax programme
as we also prepare to begin a large randomised Phase III
registration trial in mid 2006. The Phase III trial will
assess the impact of TroVax in prolonging survival of patients
with this rapidly progressive disease."
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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 70
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, Sigma-Aldrich, Viragen, MolMed
and Kiadis; and has licensed technology
to a number of companies including Merck
& Co, Biogen Idec and Pfizer.
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| 2. |
TroVax®
cancer immunotherapy |
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TroVax
is Oxford BioMedica's leading cancer
immunotherapy product. It is designed specifically
to stimulate an anti-cancer immune response
and has potential application in most solid
tumour types. TroVax targets the tumour
antigen 5T4, which is broadly distributed
throughout a wide range of solid tumours.
The presence of 5T4 is correlated with poor
prognosis. The product consists of a poxvirus
(MVA) gene transfer system, which delivers
the gene for 5T4 and stimulates a patient's
body to produce an anti-5T4 immune response.
This immune response destroys tumour cells
carrying the 5T4 protein.
TroVax
is currently in five Phase II trials, including
an investigator initiated trial sponsored
by Cancer Research UK. Over 85 patients
have been treated with TroVax (collectively
over 350 doses) in five clinical trials
in colorectal cancer and renal cell carcinoma.
Clinical results have shown that the product
is safe and stimulates an anti-tumour immune
response against 5T4 in the majority of
patients. Data from the completed Phase
I/II trial and ongoing Phase II trials suggest
that the magnitude of the immune response
induced by TroVax correlates with clinical
benefit including tumour responses and time
to disease progression, both of which have
exceeded expectation based on published
historical data. An initial Phase III trial
in renal cell carcinoma is planned to start
in 2006.
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| 3. |
Renal
Cell Carcinoma |
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Renal
cell carcinoma (RCC) is the most common form
of kidney cancer and the tenth most common
cancer in the United States. More than 150,000
people are newly diagnosed with RCC worldwide
each year. Prognosis is very poor. If RCC
has metastasised to other organs at the time
of first diagnosis, the five-year survival
rate is less than five per cent. In the United
States and Europe, RCC accounts for more than
33,000 deaths each year.
There
are no approved treatments to date that
prolong the survival of metastatic RCC patients.
Commonly used treatments for patients with
metastatic RCC include cytokines such as
interferon-alpha, which has limited efficacy,
and interleukin-2, which is associated with
side effects. About 40 per cent of patients
with RCC develop metastases after surgery.
Analyses
of sample tissues from patients with RCC
have shown that the 5T4 tumour antigen is
present at high levels on approximately
90 per cent of tumours. Hence, RCC is a
logical target for a 5T4-targeted immunotherapeutic.
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For
further information please contact:
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Oxford BioMedica plc
Professor Alan
Kingsman, Chief Executive
Peter
Nolan, SVP Commercial Development |
Tel: +44 (0)1865 783 000 |
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Enquiries
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Baderoon/Mark
Court/Mary-Jane
Johnson
Buchanan Communications |
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Scientific/Trade
Press Enquiries
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Stout/Hannah
Carter
College Hill - Life Sciences |
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