Trovax Update & Clarification
Oxford Biomedica PLC
31 July 2006
For immediate release 31 July 2006
OXFORD BIOMEDICA PLC
('Oxford BioMedica' or 'the Company')
UPDATE AND CLARIFICATION on TROVAX
Oxford, UK - 31 July 2006: Oxford BioMedica (LSE:OXB), a leading gene therapy
company, today issues an update on TroVax, the Company's leading cancer
immunotherapy product. The update provides information on progress with
clinical trial programmes and a marketing partner deal for TroVax.
The Board is pleased to confirm that the TroVax clinical development plan is on
track with appropriate regulatory submissions being made and trial centres for
the phase III TRIST study being set up in the US and Western and Eastern Europe.
Other product development programmes are also progressing according to plan. A
full update will be given with the Company's interim results on 5 September
2006.
A number of shareholders have asked for information on progress towards a TroVax
deal. The Company is in active discussions with a number of potential commercial
partners for TroVax. Inevitably those discussions are highly sensitive. All the
potential partners are substantial companies and have the capability to support
the Company's plans for TroVax and the successful marketing of this product.
Clarification as regards Therion Biologics
The Company has noted some speculation in the market that the failure of
clinical trials of PANVAC-VF, developed by the privately owned United States
company, Therion Biologics, might suggest that phase III trials of TroVax will
not be successful.
Although the Directors do not have access to detailed information on the
PANVAC-VF study, they wish to make the following comments:
• While PANVAC-VF uses a similar viral delivery system to TroVax, the active
antigenic components of TroVax are completely different to those used in
PANVAC-VF. PANVAC-VF comprises CEA and Muc-1 whereas TroVax comprises the
Company's proprietary antigen, 5T4.
• The PANVAC-VF phase III study was in pancreatic cancer patients who had
already failed chemotherapy. This is a particularly challenging target where
no product has shown a survival benefit. In the case of a vaccine the
problem is that the patients' disease advances significantly before a strong
immune response has time to be established by the product. The planned
TroVax phase III TRIST trial is in advanced renal cell cancer patients who
will have received no prior therapy for their metastatic disease and who
have a median survival, with current care, of about 12 months. As has been
shown in a number of phase I/II and phase II studies of TroVax, this is
ample time for an immune response to be established.
In summary, the Directors do not believe that data from the PANVAC-VF trial have
a significant bearing on the future of TroVax.
-Ends-
For further information, please contact:
Oxford BioMedica plc:
Professor Alan Kingsman, Chief Executive Tel: +44 (0)1865 783 000
City/Financial Enquiries:
Lisa Baderoon/ Mark Court/Mary-Jane Johnson Tel: +44 (0)20 7466 5000
Buchanan Communications
Scientific/Trade Press Enquiries:
Katja Stout/ Susan Yu/Gemma Bradley Tel: +44 (0)20 7886 8150
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 candidates in multiple Phase II trials, and a preclinical targeted
antibody therapy in collaboration with Wyeth. A Phase III trial in renal cancer
with TroVax, the lead cancer immunotherapy candidate, is expected to start in
the second half of 2006. In neurotherapy, the Company's lead product is a gene
therapy for Parkinson's disease, which is expected to enter clinical development
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, 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. TroVax has attracted
external support from Cancer Research UK and the US National Cancer Institute.
Over 120 patients have now been treated with TroVax in eight clinical trials
(collectively over 450 doses). The Company is targeting colorectal cancer and
renal cell carcinoma (RCC) as lead indications for the development of TroVax.
Renal cell carcinoma is an indication where TroVax might achieve a rapid route
to product registration. A clinical trial in prostate cancer is also underway
and a trial in breast cancer is planned.
This information is provided by RNS
The company news service from the London Stock Exchange
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