Positive Opinion on Trovax
Oxford Biomedica PLC
08 December 2006
For Immediate Release 8 DECEMBER 2006
OXFORD BIOMEDICA'S TROVAX(R)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.
-Ends-
For further information, please contact:
Oxford BioMedica plc: Tel: +44 (0)1865 783 000
Professor Alan Kingsman, Chief Executive
City/Financial Enquiries: Tel: +44 (0)20 7466 5000
Lisa Baderoon/ Mark Court/ Mary-Jane Johnson Buchanan
Communications
Scientific/Trade Press Enquiries: Tel: +44 (0)20 3008 7555
Gemma Bradley/ Susan Yu/ Katja Stout
Northbank Communications
Notes to editors
1. Oxford BioMedica
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.
Further information is available at www.oxfordbiomedica.co.uk
2. TroVax(R)
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. 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.
This information is provided by RNS
The company news service from the London Stock Exchange
IBDDXGGGGLR
Latest directors dealings
- 1 day ago Savannah Energy
- 1 day ago Buccaneer Energy PLC
- 1 day ago Savannah Energy
- 1 day ago Carclo
- 1 day ago Schroder Japan Growth Fund