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2006/OB/25
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OXFORD BIOMEDICA'S TROVAX® RECEIVES POSITIVE RECOMMENDATION FOR ORPHAN DRUG DESIGNATION IN RENAL CANCER FROM EMEA
Oxford,
UK - 8 December 2006: Oxford BioMedica (LSE: OXB), a leading gene therapy company, announced today that it has received positive opinion from the Committee for Orphan Medicinal Products (COMP) recommending orphan drug designation for TroVax for the treatment of patients with renal cancer in the European Union (EU). The COMP is part of the European Medicines Agency (EMEA). Final adoption of the opinion is expected from the European Commission in early 2007.
European
orphan drug designation ensures a ten-year marketing exclusivity
for TroVax within the EU. In addition, Oxford BioMedica and
its prospective partner will benefit from a simplified, accelerated
and cost-effective approval procedure under the consultative
guidance of the EMEA. The Company plans to request the equivalent
orphan drug status in the USA.
EU orphan
drug designation was designed to encourage the development
of products that demonstrate promise for the diagnosis, prevention
and/or
treatment of life-threatening or very serious conditions
that are rare and affect not more than 5 in 10,000 persons
in the EU. Renal cancer represents any malignant tumour
with its origin in the tissues of the kidneys. More than
150,000
people are newly diagnosed with renal cancer worldwide
each year. Prognosis is very poor. If renal cancer has metastasised
to other organs at the time of first diagnosis, the five-year
survival rate is less than 5%. In the USA and Europe, renal
cancer accounts for more than 33,000 deaths each year.
Data
from IMS suggest that over 5,000 patients in the UK received
treatment for metastatic renal cancer in 2005.
Dr Mike
McDonald, Oxford BioMedica's Chief Medical Officer, commented on the news: "This positive recommendation from the EMEA for orphan drug designation adds further momentum to the development of TroVax. It underscores the need for effective treatments for renal cancer, where treatment options are limited and the prognosis is poor."
Oxford
BioMedica commenced a pivotal multi-centre Phase III trial
of TroVax in renal cancer in November 2006. The Phase III
trial, denoted TRIST (TroVax Renal Immunotherapy Survival
Trial), is designed to evaluate whether TroVax immunotherapy,
added to first-line standard of care therapy, prolongs the
survival of patients with locally advanced or metastatic
clear cell renal carcinoma. Approximately 700 patients will
be recruited from about 120 centres in the USA, EU and Eastern
Europe. The primary endpoint for the trial is survival improvement.
Oxford BioMedica received a Special Protocol Assessment agreement
for the TRIST study from the US Food and Drug Administration
(FDA). The trial is expected to reach a conclusion in 2008-09,
which would support the Company's objective of reaching product registration in 2009 in the USA and 2010 in the EU.
Oxford
BioMedica has a key strategic objective of securing a major
corporate partner for the ongoing development and commercialisation
of TroVax. The Company has progressed to negotiations of
terms with its lead prospective partners and remains committed
to finalising a deal expeditiously.
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| Notes
| 1. |
Oxford
BioMedica plc |
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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 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 two
clinical candidates and a preclinical
targeted antibody therapy, which is being
developed in collaboration with Wyeth.
The Company has started Phase III development
of its lead cancer immunotherapy product,
TroVax, in renal cancer and multiple
Phase II trials in various cancer settings
are ongoing or planned. In neurotherapy,
the Company's lead product, ProSavin, is expected to enter clinical trials in Parkinson's disease in 2007. The preclinical pipeline includes gene-based products for vision loss, motor neuron disease and nerve repair.
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, Virxsys and Kiadis;
and has licensed technology to a number
of companies including Merck & Co, Biogen
Idec and Pfizer.
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| 2. |
TroVax® |
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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. The Company is targeting colorectal
cancer and renal cell carcinoma as lead
indications for the development of TroVax.
Renal cell carcinoma is an indication
where TroVax might achieve a rapid route
to product registration. Oxford BioMedica
has started a Phase III trial (TRIST - TroVax
Renal Immunotherapy Survival Trial) in
700 patients with advanced renal cell
carcinoma (www.trovax.co.uk). The TRIST
study received a Special Protocol Assessment
from the
US Food and Drug Administration in May
2006. A Phase II trial in prostate cancer
is ongoing and a trial in breast cancer
is due to start under the auspices of
the US Southwest Oncology Group.
To
date, over 160 patients with colorectal,
renal or prostate cancer (collectively
over 550 doses) have been treated with
TroVax. The product has attracted support
from Cancer Research UK, the US National
Cancer Institute, and the UK clinical
trials network, QUASAR. These organisations
are already conducting or plan to conduct
clinical trials with TroVax.
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